Archive for October, 2007

Finding — and Fighting — Autism Early

From the earliest months, a healthy baby engages in an astonishing range of social behaviors. Most will begin smiling back at a loved one in the first four months of life. Most will follow a parent's gaze with their own eyes by eight months. Most will also study a caregiver's facial expressions and mimic exhibits of fear, surprise or delight with their own tiny features. They will babble a conversation back and forth by nine months, respond to their names by 10 months, and begin to point to a desired toy or treat by around a year.

But some babies won't do these things, and a pattern of such deficits can be an early sign of autism. Despite these and many other early tip-offs, autism spectrum disorders (ASD) are rarely diagnosed before age 3. More subtle forms, such as Asperger's Syndrome, may not be recognized until the child begins school.

The American Academy of Pediatrics (AAP) would like to change this. At its annual meeting, held in San Francisco on Monday, the AAP released two reports: one aimed at helping pediatricians recognize autism spectrum disorders — in all their varieties — by age 2 and the other at providing guidance for early intervention. At the same time the AAP formally recommended that all pediatricians routinely screen for autism at ages 18 months and 2 years and announced it was making a new "toolkit" of diagnostic information available to all its members — for about $70.

The announcements came in response to a growing consensus that autism can be picked up very early in life and that early intervention holds the best promise for helping affected children. It is also an admission that, despite an explosion of news on autism in recent years, pediatricians are not currently doing an optimal job of identifying the spectrum of conditions now believed to affect as many as 1 in 150 children. A 2004 survey of primary care pediatricians found, for instance, that only 8% were routinely screening for autism, even though 44% said they saw at least 10 kids with autism in their practice.

The AAP had already recommended routine screening for autism in 2006, but the new recommendations are more specific and backed by more information for practitioners. Two screenings are needed — one at 18 months and one at 24 months, explains Dr. Scott Meyers, who authored one of the reports, because about a quarter of children with ASD appear to develop normally at first and then regress — losing early language and social behavior — sometime between 15 and 24 months.

Meyers, a neurodevelopmental pediatrician with Geisinger Health System in Danville, Pa., wrote the AAP's new survey of research on managing the care of children with autism. His report supports intensive behavioral and speech therapy — at least 25 hours a week — beginning as early as possible. But, he concedes, there's a lack of rigorous, randomized research on what interventions work best. The report encourages pediatricians not to condemn parents who turn to alternative therapies, but to help guide them toward the safest and best researched approaches. "Don't just dismiss it out of hand," says Meyers, "It's important to keep communication open and respect the fact that parents are going to be looking of answers."

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Men Get Breast Cancer Too

Brian Place didn't think about breast cancer when he found a lump near his left nipple. He thought about rugby. The lump, he figured, might be an injury from colliding with another player.

Place's doctor didn't think much of the lump either, but recommended a mammogram nonetheless. After that came an ultrasound of the breast and a biopsy, and then, finally, a diagnosis: breast cancer. "I was completely numb," says Place, 41 at the time. "I let my colleagues know," he says — mostly men, as he's a communications technician for the Royal Air Force in Britain. "They were as dumbfounded as I was." Even at his local breast clinic, when Place would arrive, he says, some staff assumed he was accompanying a female patient.

The confusion is understandable. Only a tiny fraction of breast cancers diagnosed — less than 1% — occur in men. And because it happens so infrequently, much is still unknown about male breast cancer. "In women, we have studies based on hundreds of thousands of patients," says Dr. Larissa Korde, staff clinician at the National Cancer Institute's clinical genetics branch. For men, there are simply no studies of that scale. Though much can be extrapolated from research in women, Korde says, often "it's a little bit harder to make recommendations for men based on evidence."

Perhaps the surest risk factor — in both women and men — is family history. By the time Place was diagnosed, for example, two of his female relatives had died of breast cancer and a third of ovarian cancer. Although there are certainly several genes that contribute to breast cancer, mutations in two of them — BRCA1 and BRCA2 — are known to increase the odds of both breast and ovarian cancers. So while most men might never even meet a man with breast cancer, those who have several relatives diagnosed with it should be on the lookout for signs of their own breast tumors. Studies suggest that certain populations with an unusually high proportion of people carrying BRCA2 mutations — in Sweden, Hungary, Iceland, and among Ashkenazi Jews — may have a higher incidence rate of breast cancer in men.

Survival rates for men and women are similar, adjusting for stage of the disease at diagnosis — but men are more likely to be diagnosed at a later stage. That's probably because women undergo regular screening, Korde says. In men, "because it's not on their radar, [a lump] might not be something they get seen immediately." In men, as in women, treatment usually includes surgery followed by some combination of radiotherapy, chemotherapy and — because almost all men with breast cancer have tumors characterized as hormone-receptor-positive — hormone treatment.

Two years after his diagnosis, Place is well. His mastectomy was a success, and he's opted to stop taking hormone treatment, a relief, he says, because he found the side-effects, including hot flashes, unpleasant. Today he tries to answer questions from male breast-cancer patients in online cancer forums, and talks with people who contact him through the U.K. nonprofit Breast Cancer Care. But there's no doubt that even a relatively positive experience with male breast cancer can be isolating — even for women. As Place looked for information in online forums, he found that women were used to treating breast cancer sites as women's-only safehouses, a place to discuss their bodies with other women. Some, he says now, "can get quite aggressive that we're invading their area, if you will." But as with breast cancer in women, awareness can make the difference.

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When the Patient Is a Celebrity

The patient in Room Four was a retired NFL lineman. None of the staff had ever heard of him, nor had I, but some of our patients had recognized him and were chatting him up — the buzz in the waiting room was palpable. In the glow of the football player's celebrity, our patients' usual cranky impatience — while waiting for X rays, cast changes, insurance calls, paperwork or simply their turn to be seen — had evaporated , eclipsed that afternoon by sheer delight.

They were waiting for the same doctor who, on the same day, would treat Johnny P.! How many people they would tell! And what confidence my patients had that day — in me. I heard no long-winded rebuttals based on what the lady in the checkout line thought I should do to treat their shoulders. So attentive and so agreeable, my patients hung on every word from Johnny P.'s doctor. Even my administrator felt the change: "We should pay that guy to come here. Everybody's so nice," she said as I gulped coffee between appointments.

A prescient comment, I'd later find out.

Helluva nice guy, this football player — and big. His knee was the size of my head. It was an arthritic knee, as you would expect — a routine problem, like hundreds of others any orthopedist sees every year. Was I extra-nice to him, though, his being a star and all? Did I do anything different that day, just a little? I like to think not, always having tried never to be a "respecter of persons."

But I was feeling the buzz. I'd never heard of Johnny, but my patients' had — and people think that sports stars automatically know who the best doctors are. (They are, of course, quite wrong.) It's a tremendous practice-builder to have a few celebs on your roster. It can also be, if you don't watch out, a tremendous ego-inflator. Not that a surgeon's legendary ego needs growth — it's usually huge enough already. Sometimes that's a good thing: Much as Johnny's star confidence elevated the mood of the office, the surgeon's big ego can often buoy up a sick patient, maybe even firing up a parallel kind of confidence in the patients, which really makes them heal better. Oft-disgusted by the surgical ego, though, I was feeling wary of it and a little embarrassed of myself.

There's a law called HIPPA that makes it illegal for doctors to reveal anything about their patients, not even their names; you are forbidden, for example, from having names written on charts visible to other patients. The goal, I guess, is to avoid situations like: "Hey, Mom, did you know that lady from church has syphilis?" Of course, we couldn't put a bag over Johnny's head, and he wouldn't have wanted that. He seemed happy for everyone to know him. The slow, cheerful deliberateness with which he acknowledged each of his new admirers shone warmly, calming the nervous air of my stressed-out suburbanite waiting room

The second time I saw Johnny P., it was a cold, rainy day. Bad weather brings cancellations and Johnny was one of the first patients of the day, so unlike his previous visit, the office was empty. We had plenty of time and he still had plenty of charm. We discussed his first round of treatment, which had been some pills and physical therapy. They hadn't worked that well but Johnny was OK with that. He made reference to some famous football stories, and I, clueless though I was, chuckled along knowingly. That got us onto the topic of other interesting NFL hijinks, including, naturally, sideline injections, which segued to arthritis injections, which were going to be an option for him, and, oh, by the way, had I thought about using new "superslime" injections for my arthritis patients in the future?

Wait. What?

Turns out the "sales" that Johnny P. was now doing for a living were in pharmaceuticals, and just recently, he said, his company had taken on superslime. Was I aware of the special introductory offer available to new surgeons, for a limited time only?

The pitch was surprising and off-putting — but salesman or not, this guy was my patient and he was in a lot of pain. I knew about superslime; there are quite a few drugs like it — injectable hyaluronic acids, basically artificial mucus, that seem to lessen joint pain in some arthritis patients. Their effectiveness in advanced arthritis isn't great, but they have little in the way of downsides — and what better psychic enhancer could I ask for than having my patient sell me the product? (Surely, it would encourage recovery more than his star power and my doctor's ego combined.) So, we went for the introductory offer, and he got his shots.

I'm happy to report that today Johnny walks, climbs stairs and cycles; he can even jog a little without knee pain. Was it the superslime? Probably not. Most likely it was the two knee replacements we did over the next six months. I see him now every year or so for a check-up. He's still a great patient and he's sent me other good ones. He called on us for a year after the surgeries selling superslime, but now only sells antihypertensives to the medical guys down the hall.

But missing now, when Johnny comes in, is the buzz. Everyone still likes him, but being a drug rep and having a couple of big knee operations somehow cost Johnny much of his celebrity status. He's still big and no longer sporting a limp, but not even his big, fat football ring elicits comments from the other patients anymore. Johnny's always still talking, joking and nodding, though — and the other patients still like him. There is a gift, some kind of divine favor that fills the air around him and it's not the football. Charisma, star quality — I've learned a little more about this good but mysterious thing since treating him. I doubt it's rubbed off on me, but I have forgiven myself for taking the extra minutes with other patients, even during busy office hours, to hear the stories.

Dr. Scott Haig is an Assistant Clinical Professor of Orthopedic Surgery at Columbia University College of Physicians and Surgeons. He has a private practice in the New York City area.

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Making Gold Miners Pay

"Thanks, mountain!" says the grizzled old prospector played by Walter Huston, in the 1948 movie The Treasure of the Sierra Madre, after he and his young partners erase evidence of their digging before heading back to civilization, burros laden with gold dust.

Huston's benevolent gesture was a sentiment decades ahead of its time. Today, gold and other precious-metal mining companies are extracting bounties of ore, leaving behind scarred mountainsides, toxic acid-rock runoffs and waste-rock dumps — and although much of the damage is on public land, the mining operations, most of which are multinationals, are not required to pay royalties on precious-metals production, and many escape liability for environmental restoration.

That tradition may be about to change. Last week, as the price of gold hit a 28-year high and platinum prices set records, a new bill was being debated by the House Natural Resources Committee, which could force the mines to pay up. For 135 years, the mines have taken wealth out of the public domain under the protection of the General Mining Law — a let-'er-rip relic of the wild frontier past that allows mines to stake claims on almost any federal land. Since the law's enactment in 1872, the U.S. government has given away more than $245 billion in mineral reserves through patenting or royalty-free mining, says Rep. Nick Rahall, the West Virginia Democrat who is behind the new bill. Compare that, he says, to the $35 billion the Treasury has reaped from coal, oil and gas produced on federal lands between 1994 and 2001 alone. "So with that scenario," says Rahall, "we are indeed Uncle Sucker."

Rahall's bill would require companies to make royalty payments on "net-smelter" profits from ore mined off federal claims. Two-thirds of those collections would go toward remediation of the $32 billion in environmental mining damage already incurred in the U.S., and one-third to help local communities adversely affected by mining operations. "We're trying to put some fair return to the American taxpayer for the use of their land," says Rahall, the new chairman of the House Interior Subcommittee. "Whether it's coal or gold mining, there are social and economic impacts that are just the same, which is why we ought to be treating all these extractive industries the same."

Though his original bill called for an 8% royalty (in contrast, companies that lease federal lands to produce crude oil, natural gas and surface-mined coal pay the government a royalty of 12.5% of the current market value of the commodity), in a recent amendment, Rahall suggested restricting the fee to new mines, and exempting existing mining operations — a move that frustrated environmental groups. After a committee vote taken last Thursday, the bill would instead oblige existing mines to pay lower royalties of 4%; new mines, 8%. "We were disappointed," said Lauren Pagel, legislative advisor with Earthworks, a nonprofit dedicated to reforming the mining law. "We're going to fight to get an amendment onto the House floor for an 8% royalty on existing mines. The royalty is needed to clean up abandoned mines. With no royalty, there will be no cleanup money."

Indeed, in Montana's Little Rockies, a gold mining operation that was abandoned in 1997 after 20 years of cyanide leaching — a method of dissolving gold from ore rocks — is still polluting the area and costing millions in public funds to monitor and treat groundwater. Pegasus Gold, the Canadian mine operator, which has since filed for bankruptcy, paid no royalties on the gold it extracted from the area, and now the Ft. Belknap Tribes of Montana, whose reservations adjoin the Little Rockies mining district, says its surface waters are showing unacceptable levels of iron, arsenic, zinc and nickel. "Our biggest fear is that the [U.S. Bureau of Land Management] and the state will not have to provide enough money to run ... water-treatment plants after August 2008," says Dean Stiffarm, environmental liaison for the tribes. "There will be only enough funding to run them six months a year."

The metals-mining industry is wary even of Rahall's amended bill, saying the fees would still be either exorbitant or unfair. "An 8% royalty for prospective mines ... would be the highest in the world. For existing mines, business plans were undertaken without figuring in paying a 4% royalty — that would be unacceptable to us," says National Mining Association spokesman Luke Popovich. "The World Bank has already said for countries seeking to have a sustainable mining industry that a gross royalty is confiscatory. If we're going to have a royalty fine, but let's put it where it's fair."

But there are some in the industry who think the royalty will actually be a boon for business. Gold mining's biggest market, the jewelry retailers, support Rahall's bill saying that environmental responsibility is what more and more of its customers are looking for: at least 80% of gold consumed goes to the superfluous bling of human adornment, and some of those customers are feeling ethical pangs.

Tiffany and Co. CEO Michael J. Kowalski early last year signed onto the "No Dirty Gold" campaign launched by the mining-reform advocate Earthworks and has drawn most of the large retailers into supporting Rahall's reform effort. The last thing image-conscious companies like Tiffany want is to be linked to controversies such as that over conflict diamonds, portrayed in the movie Blood Diamond, nor do they want to be seen as callous parties to mining disasters. "Our customers were anxious to be assured that the metals and gemstones used in Tiffany products were extracted and processed in socially and environmentally responsible ways," says Kowalski. "We come to this, not as conservationists or environmentalists, but simply as business people who really are responding to market forces. So this is not about opposing mining; this is about supporting responsible mining."

That's a cause Rahall has been trying to set in motion for 20 years. The House Natural Resources Committee made its final amendments today, and the bill is now on its way to the House for a vote. If passed intact, Rahall's bill would better protect wildlife and water sources from mining threats, in addition to requiring mining companies to pay royalties on metals mined on federal lands. Perhaps in this current eco-conscious era, the bill may finally get the green light.

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Are Microchip Tags Safe?

You may not know what RFID stands for, but you're probably using the technology on a daily basis. RFID (that is, radio frequency identification) is in passports, in electronic toll-collection tags, in credit cards, metrocards, library books and car keys. Like conventional bar codes, RFID chips store and relay information, and allow for the identification of commercial products — and, now, of house pets and people too. Human "tagging" was approved by the Food and Drug Administration in 2004 to facilitate retrieval of private medical records, but the procedure has had few takers. It's still purely voluntary and last week, California Gov. Schwarzenegger sought to keep it that way, signing a bill that makes it illegal for employers to force workers to have RFID devices implanted as a means for receiving paychecks or government benefits.

But this summer, a large pilot program involving hundreds of human patients got under way at the Alzheimer's Community Care agency in West Palm Beach, Florida. The maker of the RFID chips used in the program, VeriChip Corporation, a subsidiary of the Delray Beach–based Applied Digital Solutions, is funding the initiative and wants to market its tags to the roughly 45 million high-risk patients in the U.S. with diseases such as Alzheimer's, diabetes, cancer and heart disease. The company says these patients can benefit from having instant and accurate access to medical records, which the chip would provide. "The medical community understands the need for a comprehensive electronic medical record that has portability," says VeriChip Chairman and CEO Scott Silverman. "What goes on in emergency rooms and even in practices today is archaic. Pen-and-paper record keeping is 97% of medical records today; 98,000 deaths occurred last year in emergency rooms because of no information or inaccurate information."

To date 2,000 people worldwide have voluntarily had the VeriChip tag implanted into their upper right arms, among them patients with chronic or debilitating disease — as well as VIP patrons of a Barcelona nightclub and investigators requiring special access to confidential drug-trafficking case files at the Ministry of Justice in Mexico. Over the next two years, VeriChip and Alzheimer's Community Care plans to inject 110 patients with dementia or Alzheimer's with the chip as well. But VeriChip came under fire in September — shortly after the first 90 or so Alzheimer's patients received its chips in Florida — after an AP report unearthed studies suggesting the chips may cause cancer in laboratory animals. Within two weeks of the AP report, VeriChip's stock plummeted from just under $6 a share to a low of $3.50, a company spokesman says.

The AP cited three studies published between 1996 and 2006 that "found that lab mice and rats injected with microchips sometimes developed subcutaneous sarcomas — malignant tumors, most of them encasing the implants."

In an exclusive interview with TIME, Silverman provided a list of 34 studies the company included in its FDA application, including one of the three mentioned in the AP article, which showed that less than 1% of 4,279 chipped mice developed tumors "clearly due to the implanted microchips" but were otherwise healthy, and that "no clinical symptoms except the nodule on their backs were shown." The second study, conducted in France in 2006, two years after VeriChip's FDA application was approved, found that while 4% of the 1,260 mice in the study developed tumors, none of them were malignant. As for the third study, Silverman says it was conducted in mice specifically bred to produce tumors, and was therefore omitted from the sheaf of studies included in the FDA application. Other studies that were sent to the regulatory agency also showed tumor growth, but associated only with vaccination sites.

Dr. Lawrence D. McGill, a veterinarian and leading expert in animal pathology says the tumor development in rodents is unsurprising. "Even if you put in a bland piece of plastic, it will produce tumors in rats and mice," says McGill, who assessed the studies on behalf of VeriChip. He says it would be a leap to apply the findings of studies in mice to cats or dogs — or to humans, for that matter — which are much more complex animals. Few official scientific studies have been conducted on the effects of microchip implants on house pets, but none have found a link between the chips and cancer, says McGill. If there were a problem, he says, we would have already seen lots of cancer among the approximately 10 million pets that have been chipped over the past 15 years. Says Silverman, "There are no reported incidents to the FDA of any cancer formation around that."

In fact, there has been one case of cancer — in a French bulldog named Leon — according to a 2006 study in Veterinary Pathology. But it remains unclear whether the cancer was caused by a microchip or as the result of an injection, or who the maker of the chip was. The dog's tumor was removed in 2004, and a later examination found no recurrence. It seems that no one notified the FDA about Leon, but his case doesn't appear to worry the agency, as evident from a statement it issued when the AP brought Leon's story to light in September. "At this time, we continue to believe that the VeriChip is safe for humans," the FDA said. "In all the safety data the FDA has reviewed for this device, including extensive animal data, we have seen no evidence suggesting toxic or carcinogenic effects."

News of the tumor studies haven't yet dissuaded other groups, including Alzheimer's Community Care and the American Veterinary Medical Association (AVMA), from encouraging the use of RFID microchips. Given the large number of Alzheimer's patients in South Florida and the potential for natural disasters such as hurricanes and floods, the VeriChip comes in handy, says Mary Barnes, president and CEO of Alzheimer's Community Care, because, unlike a medical medallion, it cannot be taken off or lost. "In Palm Beach County and South Florida, we have projected over 200,000 Alzheimer's patients," Barnes says. "When you've got that kind of risk out there for our family members ... this type of technology is a godsend."

Over the next two years, Barnes will monitor how often medical records change for each of the patients in her agency's RFID program, and will track how the caregivers work with the new technology. "You don't have to be a brain surgeon to figure out this has great possibilities," she says.

Meanwhile, a handful of concerned pet owners have expressed interest in removing RFID chips from their furry companions, but VeriChip hasn't heard of anyone doing so yet. The AVMA officially counsels against removing the chip, while assuring pet owners it will continue to monitor the situation. "At this point we do not recommend that people should stop microchipping," says Dr. Rosemary LoGiudice, a veterinarian and assistant director with the AVMA. "We are actively watching. For the number of animals that are said to actually have microchips, when you consider the number of animals that have been microchipped and returned to their owners, the benefits are huge compared to the few and suspect cases that have been reported to have tumor formation."

At VeriChip, the outlook remains hopeful. Silverman says his company is bracing for the negative press by gathering up studies that prove the safety of its product. Even though the public hasn't yet warmed to RFID tagging, Silverman says that sales are brisk and expects this year to double the 1.7 million chips sold in 2006.

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