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zoom RSS 処方箋なしのボトックスをDIYで/米国医療事情

<<   作成日時 : 2009/10/30 20:06   >>

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画像 ウエブが医学的問題に対する答えを見つけやすくしているとの意見に対して専門家によってはデータ品質が保証されていないと言う。患者に被害が出るかもしれない潜在的な危険を持っている。
 7月にABCの"Good Morning America"で、シリコンを自分で注入して最終的に高価な修復手術が必要となり傷跡も残ってしまった女性の例を報告していた。Wired Science では火曜日に、処方箋なしでウエブサイトからBotoxに類似したボツリヌス菌由来薬物を購入し、顧客自身自らどう使用するかを解説したビデオを公表した。
(書きかけ)
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ボトックス指標/米国医療事情
http://kurie.at.webry.info/200902/article_12.html
ボトックスの危険性の警告を
http://kurie.at.webry.info/200801/article_50.html
ボトックス副作用関連死亡で提訴/米国
http://kurie.at.webry.info/200807/article_28.html
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DIY Wrinkle Jabs: Has Internet Medicine Gone Mad?
Why Using Google to Learn About Medicine Won't Get You an M.D.
By JOSEPH BROWNSTEIN
ABC News Medical Unit
Oct. 29, 2009
http://abcnews.go.com/Health/WellnessNews/diy-health-care-twitter-medical-blogs-making-healthier/story?id=8940249

With more information at their fingertips than ever before, people have taken to the Internet to find out about their health and in some cases act as their own doctor.
Photo: More are searching the Web for medical advice
60 percent of adults now use the Internet as a source for medical information.
(ABC News Photo Illustration)

While the Web has made answers to medical questions easier to find , it has not done as much to ensure the quality of the data, according to some health care professionals. And cases where patients have caused themselves harm have illustrated the potential perils of a society where health information and products can be gotten without the benefits of a medical degree or a prescription. Critics say Web sites have cropped up selling dubious or dangerous health products, while others simply misinform.

This change in the workings of medicine has left some wondering whether all of this advice and product availability is a good thing, but also whether it can be harnessed to improve health care.

"It's a good thing if it enables patients to make more informed decisions about their own health care and to interact more effectively with their doctors and the health care system," said Doug Evans, a research psychologist and director of public health communication and marketing at the George Washington University School of Public Health and Health Services.

"What's less clear to me is whether people taking health care into their own hands is a good thing," he said. "There's a lot of misinformation out there. The social media world, the world of blogging and Web sites that are popping up...are the Wild West."

The Web has made information more democratic, but much of it may not be good, particularly when people use it to bypass speaking with their doctors.

"I don't think people are really understanding the expertise that doctors are bringing," said Lisa Gualtieri, an adjunct clinical professor at Tufts University School of Medicine's health communications program. "I think that's part of the problem with something like this. People are thinking, 'Oh, this is less expensive or this is easy, or you don't need a medical professional for something like this.' People don't really understand the complexity of it."

In July, ABC's "Good Morning America" reported on the case of a woman who had injected herself with silicone, and ultimately needed expensive corrective surgery that still left her scarred.

But that has not dissuaded all would-be amateur plastic surgeons. Wired Science reported Tuesday about a Web site that sold botulinum-derived drugs (similar to Botox) -- without requiring a prescription -- and displayed videos of how customers could use these products on their own.

"There have been so many shows on television like "Nip/Tuck" that have really promoted nonessential cosmetic surgery, and I think that also reduces the barriers to something perhaps people wouldn't really know about…all of a sudden becomes much more accessible to people," said Gualtieri.

But then came the economic crash, which reduced incomes, but perhaps not the desire for physical improvement.

"People wanting treatments, they can't really afford it through a doctor," Gualtieri said. "I think that the shows increased people's interests in these kinds of procedures. People see this as a way to satisfy that desire to have these treatments done."

Harnessing the Power of the Web

Dr. Kevin Pho, an internal medicine doctor in Nashua, N.H., is among the most prolific physician bloggers in the United States. He uses his blog and his Twitter account in part to steer patients toward the good medical information the Internet makes available.

"I don't necessarily interact with patients directly [on the Web], but a lot of my patients read my blog," he said. "I can direct them with links pointing them to reputable sources."

Pho said another benefit of his blog is that it allows him to comment on breaking news and give patients his perspective.

"A lot of news that's being reported is not done with a lot of context," he said. While it may not be the reason he started his blog, "I think that over the years, it's certainly evolved to become a big part of why I do it."

And while some doctors may worry about patients bringing in reams of paper they have printed from various Web sites, Pho feels otherwise.

"I know there are a lot of doctors who are apprehensive, but I encourage that. I would rather have them come to me with information than act on their own."

In fact, Pho said, by being an online presence, he and other doctors can make sure that much of the information patients find is the information they would like their patients to read.

"I think it is imperative for doctors to participate with social media," he said. "We need to flood Google with more legitimate information."

Evans noted that the information currently on the Web had helped patients in some ways, particularly when it comes to alternative treatments or medications they may not have known about or that were not done in the U.S. that they can discuss with their doctor.

"My point is not that alternative medicines are a panacea…quite the contrary, but they are a potential source of treatment that people would not have had good access to without the Internet, but they are not things people should think they can use on their own and bypass the health care system, he said. "People can't just think because there's a lot of information out there and they can do Google searches, that they can be doctors."

Getting to Healthy

But sometimes even when patients know which Web sites to go to, they may not get the information they want.

"The [sites] that are most reliable are from the government -- like the NIH, the CDC, the FDA -- certainly tends to be very reliable information, and also up to date," said Gualtieri. "At the same time, it's not always the best-designed information."

"If a physician is using the site, I think he or she is able to plow through it and figure things out, but I think if a health care consumer is using the site, it's difficult to find answers to the questions that are on peoples' minds. I think all the information people want is there, but I think by providing everything to everybody, they don't make it really easy for health care consumers to get answers to their questions."

Of course, some of the most compelling information can be misleading, said Gualtieri.

She tells of reading a story online about attention deficit disorders and then seeing in the comments someone claiming a gluten-free diet helped her to overcome her ADHD.

While the story was compelling, she said acting on it would be a bad way to go about things.

"People, of course, do listen to other peoples' experiences," she said. However, the echo chamber that exists on the Web could sometimes blow a rare case out of proportion.

"That again, I think comes back to poor health literacy skills. Especially if you don't have a trusting relationship with a physician, people are more easily swayed by this kind of information."

Given the power of anecdotes, whether deliberately misleading or a personal story someone believes, "I find it very scary that people could be doing things that are potentially very harmful or disfiguring and basing their decisions on information that they read online," said Gualtieri. "I think a lot of people can be swayed by information, can be swayed by advertising, and can be swayed by other people's experiences."

---------------------------------------------------
DIY Botox: Site Offers Injectable Drug Without Prescription ― With How-To Video
http://www.wired.com/wiredscience/2009/10/botox-without-prescription/
* By Alexis Madrigal Email Author
* October 27, 2009 |
* 4:19 pm |
* Categories: Ethics, Health
*

botox-queen

A website that sells a prescription drug similar to Botox without requiring a prescription claims it has more than 2,000 customers. Some have learned how to inject the botulism-derived drug into their own faces from YouTube videos produced for the site.

Discountmedspa sells a variety of other DIY cosmetic treatments, including prescription Renova, and lip-filling gels. The botulinum toxin-derivative for sale on the site is Dysport, produced by the pharmaceutical company Ipsen and is a competitor of Allergan’s Botox. The site simply calls it “the Freeze.”

A Grand Prairie, Texas, woman, Laurie D’Alleva, who appears to be the site’s proprietor, performs treatments on herself in self-made videos posted to the site’s YouTube channel. In one video, D’Alleva pulls out a vial of what is presumably Dysport and a syringe filled with saline.

“It’s important to remember that you are mixing the potency of the botox,” she says, mixing the contents of the vial with the saline solution. She then injects her forehead and the areas around her eyes.

Ipsen received FDA clearance to sell Dysport in the United States a few months ago, but it’s a prescription medication. It’s the first direct competitor for the branded Botox, which is the most popular cosmetic treatment in America. Doctors did more than 2.4 million Botox procedures in 2008, according to the American Society for Aesthetic Plastic Surgery. In recent years, the vast amounts of money spent on the treatment have attracted scams and knockoffs, which the FDA has had to crack down on. In May, the FDA also ruled the drug needed a tougher “black-box” warning label to reflect an increased understanding of the small, but real risks of the treatment.

In the U.S., it is illegal for anyone but a doctor or nurse practitioner to prescribe drugs to patients and only pharmacists can dispense drugs to people. Yet drug sellers on the internet routinely flout the FDA’s regulations. A review published last month in the Annals of Family Medicine found more than 130 websites offering antibiotics without a prescription. The National Association of Boards of Pharmacy tracks thousands of sites that don’t meet its standards for brick-and-mortar shops. LegitScript, a private firm that works with the NABP, has database of 47,633 internet pharmacies; 46,570 of them aren’t up to snuff.

These sites are brazenly circumventing regulations that protect consumers from bad or fake drugs and ensure that the chemicals are used correctly. The laws were designed precisely to prevent Americans with little to no medical training from doing things like buying a form of toxin, mixing it with saline and injecting it into their faces. Yet, precisely that appears to be possible with the help of discountmedspa.com.

Wired.com was able to complete the ordering process on discountmedspa.com for the Freeze without being asked for a prescription. In fact, the word, “prescription” does not appear anywhere on the website.

The domain’s registration details are private, but medspacanada.com, which refers back to discountmedspa.com, is registered to Cristie Stone, with the same phone number and e-mail address listed on discountmedspa’s website. The physical address listed for medspacanada.com is the home of the Manitoba Society of Pharmacists, which has no record of Stone.

“Not only is Christie [sic] Stone not a member or the Society, I can honestly say that I have never heard her name before,” wrote Jill Ell, executive director of the society, in an e-mail to Wired.com.

Wired.com was unable to track down any trace of Stone anywhere, but did discover that D’Alleva’s maiden name is Stone.

Wired.com reached D’Alleva’s assistant, but had not heard back from D’Alleva at publication time.

The discountmedspa.com blog administrator, presumably D’Alleva posting under the handle Botox Queen, provided an explanation from a purported “long-time customer,” Tamara Lesley, explaining how the site is able to offer a prescription product.

“Laurie belongs to the Texas Medical Council and is licensed to sell these products to the women that want to use them and understand that it is their responsibility to use them safely,” she wrote.

Wired Science could not find an organization called the Texas Medical Council. It does not maintain a website and has not been mentioned in the press. A representative for the Texas Department of State Health Services had never heard of it.

Barry DiBernardo, a plastic surgeon from Mont Clair, New Jersey, had not heard of people home-administering Botox or Dysport, but did not think it was a good idea.

“I’m not aware of that,” DiBernardo said. “You need to know where the muscles are, the depth, the dosage. That doesn’t seem good.”

Short of buying and testing it, there is no way to verify that the product sold on the site is the genuine article, but the site swears by it ― and the legality of its practices.

In a blog post response to a customer’s skeptical query, Laurie provided the following explanation for the legality of her site and the provenance of her products.

I know there is much information out on the net about fillers and Botox ‘knock-offs’. This is not what I am selling! The products I have are from a company names Ipsen… I have a connection that allows me to get products that are not usually available in the states because I purchase other products in their line. Now the trick is I have to market it and label it under my own brand, to keep them and myself from getting into any legal trouble. It does take a leap of faith, but I assure you I have over 2000 customers now who love the products and are saving literally hundreds of thousands of dollars between us!

It’s unclear how D’Alleva obtains the drugs and then resells them. Ipsen did not immediately respond to a request for comment from Wired.com.

Ipsen also sells Dysport in Mexico, so it’s possible the drugs are purchased there and illegally imported into the U.S.

“If it’s prescription-only, it doesn’t matter whether it’s over the counter in Mexico or not,” said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. “Offering a prescription drug without a prescription is illegal any way you phrase it.”

Catizone also cautioned that the drugs might not actually be real, though his organization had picked up some buzz about purchasing Botox and its competitors without a prescription.

“Sometimes, if the site offers Botox, they may not really be selling Botox,” Catizone said.

Users of the site, though, testify to a variety of experiences with the drugs that seem to indicate that the Freeze is actually a botulinum toxin-derivative, as discountmedspa.com’s proprietor claims. If the site’s comments are a con ― it’s a very elaborate one.

In comments on the discountmedspa blog, users testify to watching YouTube videos of doctors doing Botox injections to learn techniques for making themselves look the way they want. Dozens of cosmetic surgeons show off their Botox procedures in videos made to promote their services.

Lesley offered a helpful hint on how to inject the Freeze to make the corners of the mouth turn up so you appear to be always smiling.

“I watched a Doctor on YouTube.com do this to a patient and he warned people not to inject below the eyes however I had to put a smile on my face too,” Lesley commented on a blog post. “The trick to this is to hold a pencil just at the corner of one side of your mouth and inject two units of Freeze at the very bottom of your chin. This will cause your [sic] very end of your mouth to turn up. Then do the other side the same way. If you don’t get it even you may have a crooked smile so be very careful that the injection is placed in exactly the same place as the other side.”

Her recommendation for another user is to “watch YouTube.com and you will learn a lot of some of the Doctors [sic] secrets to recreating your face the way you want to look.”

Other women describe mishaps with over-injecting the drug.

“My Dr. would never inject the crows feet. I did and got GREAT results!” wrote a commenter named Pat. “Unfortunately, I can’t read those little hash marks on the syringe too well and over injected above the brow on one side. A week later I’m now sporting a half closed and swollen eye, and look ready for Halloween!”

In January, Wired.com reported on other similar websites that sell Melanotan, a tanning drug that has not been approved by the FDA, which has cracked down on the drug’s manufacturers and distributors.

In response to queries from Wired.com, the Texas Department of State Health Services released the following statement, but would not comment further.

“The Texas Department of State Health Services is aware of discountmedspa.com through a complaint we received. That complaint status remains open and under review,” the agency wrote.

The complaint was made under the Texas Food, Drug and Cosmetic Act, which regulates the sale of prescription drugs like Dysport in the state.

“Botox is a prescription drug that must be dispensed or sold by a licensee pharmacy and only with a prescription from a licensed practitioner. Any over-the-counter sale of Botox is illegal,” the agency affirmed.

The Food and Drug Administration did not immediately respond to a request for comment about the illegal sale of Dysport, but asked Wired.com for the web address of the offending site.

Video: The original YouTube video was pulled by DiscountMedSpa on Wednesday, October 28. Wired.com had saved the source and has embedded that video in the story.

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