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2012年2月20日星期一

Would the real Malcolm Berko please stand up?

What stock exchange firm do you work for? Is it true that you accumulate a big holding of a stock for all of your clients and then write good things about that stock in your newspaper column so that millions of investors will read about the stock? And when all these people who read about the stock think it’s good, they buy the stock and push it up to a much higher price than what your clients paid, and then you sell it at a profit, don’t you?

Is this how you pay for your big, plush office and big staff? Your huge, multi-million-dollar home and your fancy golf club? Your expensive Mercedes and vacations in Europe?

I think this is terrible and illegal and that you should be prosecuted to the full extent of the law by the New York Stock Exchange and the Securities Exchange Commission people.

I don’t know who you’ve been talking to, but it certainly ain’t the Internal Revenue Service, my barber, my accountant or Kenny Hee, who owns the second best Chinese restaurant in Central Florida. But it’s always a hoot to hear from a reader like you. Even though your questions derive from an enormous superfluity of ignorance and anger, they are fair questions and rightly deserve to be answered.

My 15-by-20-foot office, where I employ 1.5 people, is scrunched between a beauty salon and a travel bureau. It’s located in an older, declining, 31-year-old business center that’s also home to a podiatrist, a chiropractor, a physical therapy center and a Fifth Third branch bank. My office is furnished with second- and third-hand furniture, two IBM wheel-writer typewriters, a couple of computers and an air conditioning unit that’s as old as the original wallpapering and carpets.

I live in a modest house, in a modest neighborhood, in a modest community, and I drive a diesel and an SUV, both of which are American-made. I’m not employed by a brokerage; I don’t play golf, and I’ve not been to Europe in a decade.

I write three columns for weekly publication, and if you objectively read them, common sense will tell you that the brokerage industry and I agree on only one thing: that stocks will go up and that stocks will go down. This column is anathema to the sales practices and products of the brokerage industry.

It’s so anathema, in fact, that on numerous occasions, Merrill Lynch and other brokerages have tried to silence the column through the NYSE, the National Association of Securities Dealers and the Financial Industry Regulatory Authority.

A consultant is a guy with grey hair so he can appear distinguished and hemorrhoids so he can look concerned. And I’m a consultant for several large retirement plans, in which I help the company define and select short-, medium- and long-term investment objectives. Then I help that company to select a money manager or managers who we think may best represent the plan’s objectives. And finally, I monitor the money manager or managers to be sure they’re meeting the plan’s objectives. I do not tell them when to invest or what investments to buy, nor do I tell them where to place their trades.

And if a retiring or retired employee needs to employ a personal money manager, I may be asked to help that person locate a professional he can trust. I do not buy or sell stocks for anybody. I do not have any interest in any brokerage accounts (except family accounts), and I do not participate in any commission arrangements.

I write this column because it gives me enormous satisfaction to know that over the years, it has has helped millions of investors make appropriate decisions and that their lives are much better for it. And I am reminded of this by the emails and letters I receive from folks unlike you.

2011年11月13日星期日

Dabigatran's First A Fib Year Starts Warfarin's Decline

For decades, physicians and patients bemoaned the problems and inconveniences of warfarin to prevent strokes caused by atrial fibrillation. Finding the right dosage was hard and often a moving target, patients needed regular coagulation monitoring, their anticoagulated state often fell out of the ideal range thereby putting them at an increased risk for either a stroke or bleeding complications, and care was needed with diet and other medications to avoid interactions that would throw off the whole delicate balance. A simpler, easier oral anticoagulant was what people wanted and what drove drug companies to try to find alternatives.

The first alternative, dabigatran (Pradaxa), received Food and Drug Administration approval for stroke prevention in atrial fibrillation (AF) patients about a year ago, in October 2010. Just this month, on Nov. 4, rivaroxaban (Xarelto) joined dabigatran on the U.S. market with its FDA approval for the same indication, and two more agents may follow in the next couple of years.

The initial 12-month experience with AF management in a world with a warfarin alternative showed the eagerness of some physicians and patients to embrace a not-warfarin, but also prompted the grudging recognition that warfarin has attractive features despite its flaws.

Simple numbers show that dabigatran had a good first year. In late August, Boehringer Ingelheim, the company that markets dabigatran (Pradaxa), reported that to that time U.S. physicians had prescribed dabigatran to about 350,000 AF patients, roughly 10% of the total number of U.S. patients with AF. That level of market penetration beat expectations, said Matthew Killeen, Ph.D., an analyst with Decision Resources in Burlington, Mass.

The penetration during the first year "is greater than what we previously forecast," Dr. Killeen said in an interview. Dabigatran "has done remarkably well, considering that it represents a completely new treatment strategy. It’s a completely new mindset in how physicians treat AF patients." Boehringer Ingelheim "had to lay the groundwork with physician education so that they were comfortable prescribing a pill that doesn’t need monitoring or dose adjustment."

But while dabigatran’s first year of attempting to eclipse warfarin may have exceeded expectations, it has not been a totally smooth launch, said several cardiologists recently asked about their experiences. Dabigatran succeeded despite some widely acknowledged limitations, some of which have underscored warfarin’s strengths, starting with the issue of cost.

Like any new, proprietary drug, dabigatran is expensive, with an average wholesale price in excess of $7 a day (although some pharmacies sell it for as low as about $4.50 per day), compared with an average wholesale price for warfarin of about $0.22 per day. That can put dabigatran out of the picture for patients with no drug coverage, and even for those with a drug plan, the copay often makes dabigatran a financially tough pill to swallow.

"Cost is an issue with dabigatran. I’ve had patients tell me that they’ll stay with warfarin for another couple of years until the new drugs get less expensive," said Dr. Gordon F. Tomaselli, professor of medicine and chief of cardiology at Johns Hopkins University in Baltimore.

"I think there has been limited uptake of dabigatran primarily because of cost. The out-of-pocket cost to patients can be substantial," said Dr. Deepak L. Bhatt, chef of cardiology at the Veterans Affairs Boston Healthcare system and a cardiologist at Brigham and Women’s Hospital in Boston. "It can be hard to get patients to agree to the out-of-pocket copay."

But large copays for new, more effective anticoagulants may fade as insurers realize that they can save more money in the long run by having beneficiaries treated with drugs that better prevent ischemic strokes and intracranial hemorrhages. The potential cost saving from cerebrovascular events avoided "will offset the increased drug cost," Dr. Killeen noted.

Another issue that has made physicians think twice about prescribing dabigatran has been the gastrointestinal bleeds it triggers, a 6% rate of major gastrointestinal hemorrhages during each year of treatment, said Dr. Michael D. Ezekowitz, a professor of medicine at Jefferson Medical College, Philadelphia, and one of the researchers who led the clinical trials during dabigatran’s development. Increased gastrointestinal bleeds, and an accompanying gastritis, are "the price to pay" for using dabigatran, he said in an interview, though the risk can be reduced through more careful coadministration of antiplatelet drugs, avoiding the drug in patients with gastritis or hemorrhoids, or by cauterizing telangiectasias.

Other critiques of dabigatran include on the lack of an antidote, which has made some physicians wary of prescribing it, an issue that currently limits all of the new oral anticoagulants. A physician can reverse the effect of warfarin with a simple dose of vitamin K, and some find the lack of a similar maneuver for the new drugs disconcerting, but it may not be a significant problem in actual practice, noted Dr. Lars Wallentin, professor of cardiology at Uppsala (Sweden) University and another leader of the dabigatran trials.

"In the trials [of both dabigatran and apixaban] not having an antidote was not an issue. We’ve seen no concerns" by not having an antidote. "I don’t think it’s a large problem. I think we have overestimated the bleeding risk produced by anticoagulants," he said in an interview.

For dabigatran there are also convenience issues for patients. It’s a b.i.d. drug, compared with warfarin’s once-daily dosing, and dabigatran also has the unusual problem of a very short half-life once removed from its special, desiccant-containing packaging. Once out of the package, "the efficacy of the drug goes away literally within days," noted Dr. Tomaselli. That means that patients can’t set up their dabigatran pills in advance in a Monday-Sunday pill box, something many of them like to do.

2011年7月27日星期三

Top 10 Celebrities Who'd Make Great (or Interesting) Medics

It was a late December night a few years ago, and my partner and I were bored. Perhaps boredom and cabin fever got the best of us, and since it was the holiday season, we got it in our heads to go caroling. So we hit iTunes, downloaded "The Chipmunks Christmas Album" and a few other songs, burned them to a CD, and set forth…in the ambulance.

As my partner drove around the neighborhood, I cranked the stereo up, and held the PA mike to the speaker. Most of the real carolers we encountered seemed to find it amusing, but for some reason a few homeowners weren't in as festive a mood as we were, and lodged complaints.

Later, as I was unsuccessfully feigning shame and remorse to my supervisor, I don't know what I found funnier: the look on the supervisor's face, or the fact that one of the complainants had remarked that whichever medic was singing, did a remarkably accurate impression of Porky Pig singing Blue Christmas.

My partner and I pondered the possibilities afterward (and from the duck blind during our suspension) of what it would be like to have Porky Pig as a partner. Imagine Porky delivering a patient report or asking medical control for orders, or asking a stroke patient to say, "You can't teach an old dog new tricks."

Ultimately, we had to reject the notion of Porky Pig as the perfect paramedic partner, because as funny as it might be to watch him do those things, he'd also be likely to raise his hand and ask questions during those interminably boring CE sessions, and if we ever let him order food in the drive-thru, we'd never get to eat.

2011年4月5日星期二

Plastic Surgery and...Leeches?

You've probably heard the old Bible verse, "there is nothing new under the sun." While just a moment's reflection reveals that the phrase is not really accurate, it may seem otherwise when you read about the comeback leeches are making in medical applications.

Several years ago, it, a website that presents news on science, technology and medicine in an accessible format, reported that both maggots and leeches were again being used by doctors to treat wounds that weren't healing properly and during surgical procedures that were likely to cause blood to pool and restrict healthy circulation.

LiveScience noted that in centuries past, leeches took on all kinds of health challenges from headaches to hemorrhoids--the dubious to the logical, you might say. Today they're most often used to "drain blood from swollen faces, limbs and digits after reconstructive surgery."

You're not alone if the thought grosses you out. You might feel slightly better to know that in 2004 the United States Food and Drug Administration approved the marketing of maggots and leeches for medicinal use in the U.S. and regulates them as they do other "medical devices." Also, today's medical grade leeches are raised in a clean environment, not harvested from muddy rivers and stagnant swamps.

In plastic surgery applications, leeches have several advantages. The first is their efficiency in helping blood to drain from small body parts where veins are easily clogged. The many proteins secreted in leech saliva also help numb pain. All this and a potentially modest price tag too: the article posted on the LiveScience website reported that 500-1,000 medical-grade leeches cost about $70 in 2004.

Plastic surgeons are starting to use leeches more often as a way to promote healing after reconstructive surgery. The creatures, technically segmented worms with the scientific name Hirudo medicinalis, are used primarily after surgery on areas where the blood vessels are small, such as fingers, hands and ears. Leech therapy can also be effective in cases involving skin flaps transplanted from one part of the body to another.