Cure vs. Hype - Is new MS research the real thing, or a media-driven frenzy? - National Post

For long-suffering multiple sclerosis patients, it seemed like a miracle: a relatively simple new explanation for what causes the often-crippling disease, and an equally straightforward fix.

Indeed, glowingly positive Canadian media accounts of work by Italy's Dr. Paolo Zamboni, who says the disease can be treated by unblocking veins from the brain, have triggered a sensation across the MS world -- and raised questions about how journalists and scientists portray medical research to the public.

Clinics throughout Canada and the United States have been deluged with calls and emails from patients eager to learn more or demanding immediate treatment with the new technique, often bringing the offices' regular work to a halt, physicians say.

Some doctors report that patients have gone off their medication, with potentially long-term negative implications. Others have talked of taking out loans or even selling their houses to fund the experimental therapy. Almost overnight, the MS Society directed hundreds of thousands of dollars in funding to study of the new concept.

Meanwhile, neurologists trying to explain the limitations of Dr. Zamboni's findings have faced sometimes angry recriminations from patients desperate for a cure.

"Many of the callers were very abusive, right from the start," said Dr. Luanne Metz, director of the Foothills Hospital MS clinic in Calgary. "Nasty to the nurses, accusing us of withholding treatment or playing Big Brother and not letting people have what they want, and arguing and arguing and arguing."

MS specialists blame the over-heated response in large part on that CTV documentary and an accompanying newspaper report, calling the stories one-sided depictions of preliminary, unproven research, including the treatment Dr. Zamboni evocatively terms the "Liberation" procedure.

At best, his work represents a promising new way of looking at MS that requires much more validation and testing before it can be widely applied, experts say. At worst, the more rigorous investigation now getting underway will show it to be a scientific dead end.

Most MS neurologists interviewed recently said they welcome the expanded research into Dr. Zamboni's theory, if only to settle the controversy; others lament what they consider a media-driven distraction. "There have been reverberations across the world as a result of that media story," said Dr. Mark Freedman, a neurologist at Ottawa Hospital and a top MS researcher. "I think there are going to be millions of dollars spent now to follow a hoax.... If I thought for one instant there was substance to this, I'd be all over it. But there really is very, very vague backing for the whole theory."

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http://www.nationalpost.com/news/story.html?id=2475272

Doctor and Patient - Offering Care for the Caregiver - NYTimes.com

The man was nearing 90, losing his sight and showing signs of early dementia. After examining his abdomen, I fumbled trying to help him get his shirt and pants back on. After an awkward few seconds, the patient's middle-aged son sprang forward from his seat near the door and began working through the buttons, zipper and belt with a practiced deftness.

"Daddy," he murmured softly as his fingers nimbly pushed each pearly button through its hole, "you can usually do this yourself, can't you?" He continued cajoling his father, as he cinched the old man's belt and patted the haphazard pleating that appeared around his waistline. "You can even feed yourself if I help get your food on the spoon, can't you?"

My patient nodded absentmindedly, smiling at the fluorescent lights on the ceiling and tapping his fingers against his drooping mouth.

I felt as if I had just witnessed a scene that played itself over and over again every morning.

Later outside the exam room, the son pulled me aside. I noticed the dark circles around his eyes. "You're tired, aren't you?" I asked him.

The man's dark eyes began to fill with tears. I immediately, reflexively almost, started apologizing for not being able to do more for his father. But he stopped me.

"No, no," he said, wiping the tears away with the back of his hand. "It's not that. It's not that at all." He paused and looked toward his father, still lying on the table in the room and smiling at the lights. "It's just that no doctor has ever asked me if I was tired."

In truth, I probably would have never done so either except that a few years ago, I too had spent time caring for a frail loved one.

For all our assertions about the importance of caring in what we do, doctors as a profession have been slow to recognize family members and loved ones who care for patients at home. These "family caregivers" do work that is complex, physically challenging and critical to a patient's overall well-being, like dressing wounds, dispensing medication, and feeding, bathing and dressing those who can no longer do so themselves.

Many of these caregiving tasks were once the purview of doctors and nurses, a central component of the "caring professions." But over the past century, as these duties increasingly fell to individuals with little or no training, doctors and even some nurses began to confer less importance, and status, to the work of caregiving.

It comes as no surprise, then, that physicians now rarely, if ever, learn about what a family caregiver or health care aide must do unless they are faced with caring for their own loved ones. We doctors don't know or aren't always fully aware of what it takes to care for a patient after we leave the room.

In other words, for the 37 million people attending to the health care needs of a relative, partner, friend or neighbor, our best care goes only so far.

"If you look at the amount of time devoted to actual caregiving, the physician contributes a very modest amount," said Dr. Arthur Kleinman, a professor of medical anthropology and psychiatry at Harvard Medical School and now a family caregiver himself.

"We've had outstanding diagnoses and very careful attention to defining the problem," Dr. Kleinman said, referring to his own experience. "But once the problem is defined and the limited pharmacological interventions prescribed, there has been neither interest nor knowledge about the rest of the aftercare, even in the most simple parts like finding a home health aide or getting a needs assessment by a social worker."

But our profession's indifference may hopefully soon be a thing of the past.

This month, the American College of Physicians, the country's leading professional organization of internal medicine physicians, issued its first position paper on working with caregivers. Endorsed by almost a dozen other professional medical organizations, the paper, published in The Journal of General Internal Medicine, highlights the challenges that can arise from the complex interaction among patient, doctor and caregiver and offers guidelines for providing the best care.

Using a framework of broad principles, like the need to respect and maintain a primary focus on the patient's rights, dignity and values, the paper explores specific issues that are likely to arise in a given patient-doctor-caregiver relationship. How, for example, should physicians approach long-distance family caregivers? What should they consider when working with the caregiver of a terminal patient? How can they best support the caregiver who is convinced that he or she can never do "enough"?

"Normally everyone is always focused on the patient, patient autonomy and the patient's wishes in terms of the ethical standpoint," said Dr. Virginia L. Hood, chairwoman of the Ethics, Professionalism and Human Rights Committee of the American College of Physicians and one of the paper's authors. "But family caregivers are an important part of the health care team, too. We need to value these caregivers better, think about their needs and consider how they are central to the patient's care, not just someone who happens to be pushing the wheelchair."

Of particular importance is understanding how the work of caregiving can also give rise to a new set of medical issues: those of the caregiver.

Caregiving duties place tremendous stresses on an individual, and not all of those stressors are simply physical and emotional. "Some of these 37-going-on-40 million family caregivers have had to give up their own jobs in order to care for the patients," Dr. Hood said. "That means they aren't going to be able to put aside money for their retirement. Who is going to take care of them and their medical problems in the future?"

Caring for more people can be difficult for physicians who are already stretched and not reimbursed for additional time spent with patients. "This tension regarding time and reimbursement has to be resolved," Dr. Hood said. But, she added, "if the physician needs to spend more time with patients and their caregivers in order to make things better for the patients, then it has to be done; it's all about the patient."

And perhaps, it is also about how we define care, whether that care is provided by family members and loved ones, or by doctors and other clinicians.

"There is a moral task of caregiving, and that involves just being there, being with that person and being committed," said Dr. Kleinman, of Harvard Medical School. "When there is nothing that can be done, we have to be able to say, 'Look, I'm with you in this experience. Right through to the end of it.' "

http://www.nytimes.com/2010/01/22/health/21chen.html

National Journal Magazine - If Air Travel Worked Like Health Care

"Hello! Thank you for calling Air Health Care, the airline that works like the health care system. My name is Cynthia. How can I give you travel care today?"

"Hi. My name is Jonathan Rauch. I need to fly from Washington, D.C., to Eugene, Oregon, on October 23."

"Yes, I'd be happy to assist you with that. It does look like we can get you on a flight on January 23 at 1 p.m. or February 8 at 3 p.m. Which would you prefer?"

"Neither. I need to be in Eugene on October 23. As in, the 23rd of October."

"I'm sorry, we have nothing open on that date. You might try another carrier."

"I suppose I'd better. Who has availability?"

"I'm afraid I have no way to know that. I have no way to look into their systems."

"Who would know?"

"You can call them individually and ask. I'm sure you can find one."

"Look, I don't have time to call two dozen airlines. It's important that I get to Eugene on the 23rd. There must be something you can do."

"Well, it looks like maybe we could squeeze you in on October 26, if you don't mind departing Washington Dulles at 5:35 a.m."

"Good grief. All right, I suppose it will do."

"Great, thank you, I'll be happy to make that booking for you. That's one flight from Washington Dulles to Chicago O'Hare on October 26. Will there be anything else?"

"Wait, hold on. Chicago? I'm going to Eugene. It's in Oregon."

"Yes, sir. The Eugene portion of your trip will be handled by a western specialist. We'll be glad to bring you back from Chicago to Washington, though."

"You mean I have to call another carrier and go through all this again? Why don't you just book the whole trip?"

"Sorry, sir, but you do need to make your own travel appointments. We would be happy to refer you to some qualified carriers. May I have your fax number, please? Before I can confirm the booking, we'll need you to fill out your travel history and send that back to us."

"Cynthia, I have filled out my travel history half a dozen times already this year. I've told six different airlines that I flew to Detroit twice and Houston once. Every time I fly, I answer the same battery of questions. At least a dozen airlines have my travel history. Why don't you get it from them?"

"We have no way we could do that. We do not have access to other companies' records, and our personnel have our own system for collecting travel history."

"But 95 percent of these questions are always the same. Don't you know that every time I fill out one of these duplicative forms I increase the chance of error? Wouldn't it make more sense to hold my travel information centrally, so that everyone could see the same thing?"

"Sorry, sir, we have no capability for that, and we do need to have your travel history at least two weeks before you fly."

"I don't suppose I could fill out these forms online?"

"No, sir. The forms are only about 30 pages, though. Did you have that fax number, please?"

"I don't have a fax machine. No one faxes anymore. Just e-mail me the forms."

"I'm sorry, sir, we don't use e-mail to transmit records and other personal or secure documents. We keep our records on paper."

"What century is this? You think paper is secure?"

"We do keep all your travel records on low-acid paper and in fire-retardant file drawers. When someone needs access to your records, we make a photocopy and put them in the mail. Or fax. How many items of luggage were you wanting to bring?"

"Two."

"OK, good. We suggest you make luggage arrangements with Rapid Air Transport, though of course you're free to use any luggage company you like."

"Luggage company?"

"Yes, sir. You'll need to arrange baggage transport. Would you like a phone number for Rapid, or would you prefer to find your own baggage company? I'm sure Rapid would be pleased to work with you. All you need to do is sign the Personal Travel Records Release form. Where would you like me to mail that?"

"Release form?"

"Yes, sir. You'll need to sign and fax or mail that back to our Travel Records Department so that we can release your travel records to Rapid. Under the privacy rules, we're not authorized to tell them when or where you're flying without your written permission."

"I suppose I couldn't just e-mail you this permission, or grant it online?"

"No. Did you want a list of luggage carriers for your Chicago-Eugene leg?"

"Let me guess. Rapid doesn't operate out West. I have to find a separate luggage company for the second leg."

"Yes, sir."

"And they'll need more copies of all the same paperwork. And they'll ask me all the same questions. And I'll have to arrange to get my travel records to them by mail or fax. And I'll repeat all this nonsense five or six separate times between here and Eugene, because the providers aren't equipped to talk to each other and my records aren't digitized and no two providers use the same system."

"Yes, sir, that's right! Did you have a preferred fuelist, or did you want a reference for a company to provide jet fuel for your flight?"

"Fuelist. That would be a fuel specialist, I suppose."

"We can make a fuel arrangement for you, but please be advised that the fuelist's charge will be billed separately and you will be responsible for it. We'll need to know where to have that bill sent.

"May I have your flight-insurance information, please?"

"Millennium Travel Care, group number 068832, ID number RS-3390041B."

"I'm sorry, sir, we're not in Millennium Travel Care's provider network."

"You're listed on their website. It says you accept Millennium."

"We did until last week. If you like, you can pay out of pocket for your ticket."

"How much would that be?"

"Yes, sir, I'll be happy to get that price for you. That would be $17,885.70."

"What? For a flight to Chicago? Does anyone actually pay that?"

"I'm sorry, sir, I wouldn't know. I can tell you that different clients and insurers pay different rates. For individuals, the rate is $17,885.70."

"Oh."

"Plus tax. And fuel."

"Is anyone else cheaper?"

"Sir, again, I couldn't tell you that. Carriers don't have public rate sheets. Prices are privately negotiated, so there's really no way you could comparison shop."

"Oh."

"Did you want to go ahead, then?"

"No. I DO NOT WANT TO GO AHEAD. I do not want to go anywhere! I want to jump off a cliff!

"This system is insane. It is fragmented to the point of incoherence. Record-keeping is stuck in the 1960s. Communication is stuck in the 1980s. None of the systems talks to the others. Everyone reinvents the wheel at every stage of the process. There is no pricing transparency.

"In a sane, modern system, I wouldn't have to arrange each leg of my flight myself. I wouldn't have to fax documents around, find and juggle multiple providers, fill out again and again what are essentially the same forms every time I use a provider.

"In a sane system, I would call an airline and it would give me a price for the whole trip, not just for one part of it. It would sell me a safe round-trip journey, instead a series of separate procedures. It would have back-office personnel using modern IT systems to coordinate my journey behind the scenes. The systems and personnel would talk to each other automatically. At the press of a button, once I entered a password, they would be able to look up my travel history. We'd do most of this stuff online.

"In fact, Cynthia, I would be able to arrange a whole trip with a single phone call!"

"Sir. Please. Calm down and be realistic. I'm sure the system can be frustrating, but consumers don't understand flight plans and landing slots. Even if they did, there are thousands of separate providers involved in moving travelers around, and hundreds of airports, and millions of trips. Getting everyone to coordinate services and exchange information just isn't realistic in a business as complicated as travel."

"Yes. I suppose I'm dreaming."

"Was there anything else I could help you with?"

"No."

"My goal today was to provide you with outstanding service. Did I accomplish that?"

[click]

http://www.nationaljournal.com/njmagazine/print_friendly.php?ID=st_20090926_4826

Is Marijuana Good Medicine? - WSJ.com

Charlene DeGidio never smoked marijuana in the 1960s, or afterward. But a year ago, after medications failed to relieve the pain in her legs and feet, a doctor suggested that the Adna, Wash., retiree try the drug.

Ms. DeGidio, 69 years old, bought candy with marijuana mixed in. It worked in easing her neuropathic pain, for which doctors haven't been able to pinpoint a cause, she says. Now, Ms. DeGidio, who had previously tried without success other drugs including Neurontin and lidocaine patches, nibbles marijuana-laced peppermint bars before sleep, and keeps a bag in her refrigerator that she's warned her grandchildren to avoid.

"It's not like you're out smoking pot for enjoyment or to get high," says the former social worker, who won't take the drug during the day because she doesn't want to feel disoriented. "It's a medicine."

For many patients like Ms. DeGidio, it's getting easier to access marijuana for medical use. The U.S. Department of Justice has said it will not generally prosecute ill people under doctors' care whose use of the drug complies with state rules. New Jersey will become the 14th state to allow therapeutic use of marijuana, and the number is likely to grow. Illinois and New York, among others, are considering new laws.

As the legal landscape for patients clears somewhat, the medical one remains confusing, largely because of limited scientific studies. A recent American Medical Association review found fewer than 20 randomized, controlled clinical trials of smoked marijuana for all possible uses. These involved around 300 people in all—well short of the evidence typically required for a pharmaceutical to be marketed in the U.S.

Doctors say the studies that have been done suggest marijuana can benefit patients in the areas of managing neuropathic pain, which is caused by certain types of nerve injury, and in bolstering appetite and treating nausea, for instance in cancer patients undergoing chemotherapy. "The evidence is mounting" for those uses, says Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego.

But in a range of other conditions for which marijuana has been considered, such as epilepsy and immune diseases like lupus, there's scant and inconclusive research to show the drug's effectiveness. Marijuana also has been tied to side effects including a racing heart and short-term memory loss and, in at least a few cases, anxiety and psychotic experiences such as hallucinations. The Food and Drug Administration doesn't regulate marijuana, so the quality and potency of the product available in medical-marijuana dispensaries can vary.

Though states have been legalizing medical use of marijuana since 1996, when California passed a ballot initiative, the idea remains controversial. Opponents say such laws can open a door to wider cultivation and use of the drug by people without serious medical conditions. That concern is heightened, they say, when broadly written statutes, such as California's, allow wide leeway for doctors to decide when to write marijuana recommendations.

But advocates of medical-marijuana laws say certain seriously ill patients can benefit from the drug and should be able to access it with a doctor's permission. They argue that some patients may get better results from marijuana than from available prescription drugs.

Glenn Osaki, 51, a technology consultant from Pleasanton, Calif., says he smokes marijuana to counter nausea and pain. Diagnosed in 2005 with advanced colon cancer, he has had his entire colon removed, creating digestive problems, and suffers neuropathic pain in his hands and feet from a chemotherapy drug. He says smoking marijuana was more effective and faster than prescription drugs he tried, including one that is a synthetic version of marijuana's most active ingredient, known as THC.

The relatively limited research supporting medical marijuana poses practical challenges for doctors and patients who want to consider it as a therapeutic option. It's often unclear when, or whether, it might work better than traditional drugs for particular people. Unlike prescription drugs it comes with no established dosing regimen.

"I don't know what to recommend to patients about what to use, how much to use, where to get it," says Scott Fishman, chief of pain medicine at the University of California, Davis medical school, who says he rarely writes marijuana recommendations, typically only at a patient's request.

Researchers say it's difficult to get funding and federal approval for marijuana research. In November, the AMA urged the federal government to review marijuana's position in the most-restricted category of drugs, so it could be studied more easily.

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http://online.wsj.com/article/SB10001424052748703626604575011223512854284.html?mod=googlenews_wsj

Researchers Find Study of Medical Marijuana Discouraged - NYTimes.com

Despite the Obama administration's tacit support of more liberal state medical marijuana laws, the federal government still discourages research into the medicinal uses of smoked marijuana. That may be one reason that — even though some patients swear by it — there is no good scientific evidence that legalizing marijuana's use provides any benefits over current therapies.

Lyle E. Craker, a professor of plant sciences at the University of Massachusetts, has been trying to get permission from federal authorities for nearly nine years to grow a supply of the plant that he could study and provide to researchers for clinical trials.

But the Drug Enforcement Administration — more concerned about abuse than potential benefits — has refused, even after the agency's own administrative law judge ruled in 2007 that Dr. Craker's application should be approved, and even after Attorney General Eric H. Holder Jr. in March ended the Bush administration's policy of raiding dispensers of medical marijuana that comply with state laws.

"All I want to be able to do is grow it so that it can be tested," Dr. Craker said in comments echoed by other researchers.

Marijuana is the only major drug for which the federal government controls the only legal research supply and for which the government requires a special scientific review.

"The more it becomes clear to people that the federal government is blocking these studies, the more people are willing to defect by using politics instead of science to legalize medicinal uses at the state level," said Rick Doblin, executive director of a nonprofit group dedicated to researching psychedelics for medical uses.

On Monday, his last full day in office, Gov. Jon S. Corzine of New Jersey signed a measure passed by the Legislature last week that made the state the 14th in the nation to legalize the use of marijuana to help with chronic illnesses.

The measure was pushed by a loose coalition of patients suffering from chronic illnesses like Lou Gehrig's disease and multiple sclerosis who said marijuana eased their symptoms.

Studies have shown convincingly that marijuana can relieve nausea and improve appetite among cancer patients undergoing chemotherapy. Studies also prove that marijuana can alleviate the aching and numbness that patients with H.I.V. and AIDS suffer.

There are strong hints that marijuana may ameliorate some of the neurological problems associated with such degenerative diseases as multiple sclerosis, said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego.

But there is no good evidence that legalizing the smoking of marijuana is needed to provide these effects. The Food and Drug Administration in 1985 approved Marinol, a prescription pill of marijuana's active ingredient, T.H.C. Although a few small-scale studies done decades ago suggest that smoked marijuana may prove effective when Marinol does not, no conclusive research has confirmed this finding.

And Marinol is no panacea. There are at least three medicines that in most patients provide better relief from nausea and vomiting than Marinol, studies show.

Buddy Coolen, 31, of Warwick, R.I., said he tried or continued to use some of those medicines. "Smoking for me is as good as any medicine I have," he said.

Eight years ago, Mr. Coolen contracted gastroparesis and cyclic vomiting syndrome. He lost 50 pounds and, despite being 5 foot 11, weighed 120 pounds.

His doctors gave him myriad anti-emetics, many of which he still takes. They also prescribed Marinol, but it did not work for him, Mr. Coolen said.

"My stepdad is old school and was really against marijuana, but then he saw what it did for me and totally changed his way of thinking," Mr. Coolen said.

Some doctors and law enforcement officials say such anecdotes should not drive public policy. Dr. Eric Braverman, medical director of a multispecialty clinic in Manhattan, said legalizing marijuana was unnecessary and dangerous since Marinol provided the medicinal effects of the plant. "Our society will deteriorate," he said.

Patients who call Dr. Braverman's clinic are, when put on hold, told that the clinic may prescribe supplements and other alternative treatments that have even less scientific justification than marijuana. Dr. Braverman said such alternatives rendered marijuana unnecessary, but his embrace of alternatives is a reminder that medicine has long been driven by more than science.

About 20 percent of drug prescriptions are written for uses that are not approved by federal drug regulators; about half of the nation's adults regularly take supplements; herbal and homeopathic remedies are popular.

The nation's growing embrace of medical marijuana has stemmed from these alternative traditions.

The University of Mississippi has the nation's only federally approved marijuana plantation. If they wish to investigate marijuana, researchers must apply to the National Institute on Drug Abuse to use the Mississippi marijuana and must get approvals from a special Public Health Service panel, the Drug Enforcement Administration and the Food and Drug Administration.

But federal officials have repeatedly failed to act on marijuana research requests in a timely manner or have denied them, according to a 2007 ruling by an administrative law judge at the Drug Enforcement Administration. While refusing to approve a second marijuana producer, the government allowed the University of Mississippi to supply Mallinckrodt, a drug maker, with enough marijuana to eventually produce a generic version of Marinol.

"As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use," said Shirley Simson, a spokeswoman for the drug abuse institute, known as NIDA. "We generally do not fund research focused on the potential beneficial medical effects of marijuana."

The Drug Enforcement Administration said it was just following NIDA's lead. "D.E.A. has never denied a research registration for marijuana and/or THC if NIDA approved the protocols for that individual entity," a supervisory special agent, Gary Boggs, said by e-mail.

Researchers investigating LSD, Ecstasy and other illegal drugs can use any of a number of suppliers licensed by the Drug Enforcement Administration, Dr. Doblin said. And if a researcher wants to use a variety of marijuana that the University of Mississippi does not grow — and there are many with differing medicinal properties — they are out of luck, Dr. Doblin said.

Law enforcement tends to emphasize the abuse potential of medicines without regard to their positive effects. Bureaucratic battles between the D.E.A. and the F.D.A. over the availability of narcotics — highly effective but addictive medicines — have gone on for decades.

So medical marijuana may never have good science underlying its use. But for patients in desperate need, the ethics of providing access to the drug are clear, said Dr. Richard Payne, a professor of medicine and divinity and director of the Institute for Care on the End of Life at Duke Divinity School.

"It's not a great drug," he said, "but what's the harm?"

http://www.nytimes.com/2010/01/19/health/policy/19marijuana.html?th=&emc=th&pagewanted=print