2010年11月20日土曜日

遺伝子検査ビジネス

遺伝子検査ビジネスが急増しているようだ。
 日本人類遺伝学会は、科学的な根拠、有用性がはっきりしないとして、
専門家による検証や国による監督の体制作りを急ぐべきだとする提言を
まとめた。

経産省
・昨年度まとめた調査結果では、市場規模は9億円。

国民生活センター
・病院でがんに関係する遺伝子検査を受け、40万円を支払った。
・検査結果は「がんに関係する遺伝子はない」。しかし、数カ月後に肺がん
 と診断された。

日本人類遺伝学会
・専門家による第三者の検証機関の創設、法整備などを求める見解案を
 まとめた。
・「検査ビジネスはあたかも病気、能力、性格、進路の適性を確実に
 予測できるかのように誤解を与えている場合も少なくない」と判断。

韓国
・2005年に遺伝学的検査の質の保証と、遺伝子差別の禁止を定めた法律が施行。

米国
・2008年、個人情報の保護を目的に遺伝情報による差別を禁止する法律が
 制定。遺伝情報で医療保険に差をつけることが懸念されたのが一因。
・GINA(Genetic Information Nondiscrimination Act)により、雇用主が
 遺伝情報に基づいて仕事で区別するのを禁じ、雇用主によって養子縁組、
 4親等までの家族を含む遺伝情報の獲得と発表を制限。
 不注意による情報入手、従業員による健康診断依頼等の例外有

英国
・2011年までは、保険業者による自主規制。
・2014年から、遺伝子検査結果を採用する可能性が有。

乳がん、アルツハイマー、ハンチントン病、嚢胞性繊維症等の難病を含む
病気から薄毛、肥満、知能等の遺伝とされる通説までがビジネスになって
いるようだ。

アルツハイマーの遺伝子を保有しても発病しない人もいると言われるし、
肥満や知能は、後天的な原因がほとんどと言われる。
ブームは、健康から、遺伝子に広がったのだろう。

精子や卵子バンクは、遺伝子の固有の特性を特長として、ビジネスが成立
しているように思えるが、GINAは、ここには規制をかけないようだ。
矛盾しないのだろうか。


---遺伝子検査:手軽さと危うさ 科学的根拠乏しく、学会は過熱懸念---
毎日新聞 2010年11月16日 東京朝刊
http://mainichi.jp/select/science/news/20101116ddm016040020000c.html

 依頼に応じて個人の遺伝子を調べ、肥満や生活習慣病などの可能性を予測するサービスが増えている。予防への活用が期待される一方、高額な料金で科学的根拠が薄い予測を出したり、子供の能力を調べる業者も現れた。手軽さの半面、危うさもはらむ遺伝子検査ビジネス。専門家でつくる学会がこのほど、国による監視を求める声明を発表するなど、過熱を心配する声もある。【河内敏康】

■血液や粘膜から
 東京都内のあるクリニックで遺伝子検査を受けてみた。
 腕に注射針を刺し、2ミリリットルほどの血を採る。このクリニックは、血液を大阪市の検査会社「サインポスト」に送って調べている。同社は大阪大医学部発のベンチャー企業で、肥満、糖尿病、脳卒中につながりやすい血栓など、62種類の遺伝子を解析。過去の6000人以上の症例から導いた平均値と比べた、その人の体質の「危険度」を判定する。1~2週間すると、結果がクリニックに送られ、依頼者に通知される。名前などの個人情報は暗号化されている。1回3万1500円で受けることが可能だ。
 人の遺伝子は全体で約2万数千個あるとされる。遺伝子を調べると、何が分かるのか。
 遺伝子検査ビジネスの多くは、病気との関連が明らかになっている遺伝子を調べ、そこにあるDNAの塩基配列を詳しく調べる。調べる対象は多様だ。たった一つの遺伝子の異常が引き起こす遺伝病もあるが、例えばがんは複数の遺伝子異常に生活習慣などが重なって生じる「多因子疾患」だ。薬の効きやすさや副作用の出やすさといった個人差、男性型脱毛症の可能性も分かる。
 採血より手軽に、自宅でほおの内側の粘膜をこすり取り、そこに含まれる細胞からDNAを取り出す方法もある。サインポスト社長の山崎義光・大阪大先端科学イノベーションセンター招聘(しょうへい)教授は「我々の遺伝子検査は確定診断ではなく、どんな体質を持っているかを調べるのが目的。特定の病気や症状へのリスクが高いと分かれば、医師が指導して食事や運動など生活習慣に注意することで、予防に役立てられると期待できる」という。

■信頼性に疑問も
 こうした遺伝子検査ビジネスを疑問視する専門家も少なくない。日本人類遺伝学会理事の福嶋義光・信州大教授(遺伝医学)は「有用性が証明されている検査はほとんどない」と指摘する。
 多因子疾患のリスクを調べる場合、発症に関係する遺伝子は複数ある。一つの遺伝子を調べただけでは、発症にどれほど影響しているのか把握は難しい。
 例えば、アルツハイマー病発症にかかわる危険因子として知られる「アポリポたんぱく質E4(アポE4)」。このたんぱく質を作る遺伝子を持つ人の発症リスクは、持たない人の約4倍だが、実際には持っていても約9割が発症しない。
 遺伝子検査の目的を「あらかじめ危険性を知って予防する」と考えた場合、有効な予防・治療法がまだないアルツハイマー病に関して遺伝子検査をする意義が問われることになる。
 肥満の遺伝子検査にも福嶋教授は疑問を呈する。基礎代謝量に関係する複数の遺伝子を調べ、太りやすい体質かどうかを調べるものだが「肥満は遺伝より、食生活や運動など環境要因の方が大きく影響する。中には依頼者に、肥満予防のための健康食品などを勧める場合もある。その健康食品に確実に効果があるという科学的根拠も示すべきだ」と話す。
 実際、トラブルも起きている。国民生活センターによると、遺伝子検査をめぐる相談は07年ごろから寄せられるようになった。40万円を支払ってがんに関する遺伝子検査を受け、「がんの因子はない」と通知された依頼者が、2カ月後にがんになったという例もある。

■子どもの能力まで
 特に問題視されているのが、子どもを対象とした遺伝子検査だ。特定の遺伝子を「知能や性格、能力に関係する」と見なし、遺伝子を調べて潜在能力を予測する。韓国では「十分な科学的妥当性がない」として法律で禁止されている。
 東京大医科学研究所の洪賢秀・特任助教(文化人類学)は「遺伝子検査の結果によって親が子どもの進路を大きく変え、子どもに不利益をもたらす可能性がある」と警告する。
 日本人類遺伝学会(中村祐輔理事長)は10月、一般人を対象にした遺伝子検査ビジネスについて「科学的な根拠や有用性が確認されていない」として、専門家による検証や国による監視体制を早急に構築すべきだとする提言をまとめた(右表に要旨)。米国など多くの国が遺伝子検査ビジネスを規制しているのに対し、日本は手つかずなのが現状だ。
 福嶋教授は「遺伝子検査の結果は一生ついて回り、似た遺伝的体質を持った家族にも影響する可能性がある。教育に使えば子どもの可能性を狭める危険性があり、法規制が必要になるかもしれない。また、健康に関係する遺伝子検査ならば、(科学的根拠に基づいて)保険が適用されるような医療の枠組みの中で実施してほしい」と話す。
==============
■日本人類遺伝学会の提言(要旨)
 (1)一般市民対象の遺伝子検査には、臨床遺伝専門医などが関与すべきだ
 (2)消費者が不利益を受けないよう、遺伝子解析の意義や有用性などの科学的検証を継続的に行うべきだ
 (3)(学会関係者は)一般市民や学校教育関係者などに、遺伝子検査がもたらす意味を教育・啓発し、遺伝子検査の理解が促進されるように努力すべきだ
 (4)日本でも遺伝子検査を監視・監督する体制の確立を早急に検討すべきだ


---Fears for genetic test as insurers will review their voluntary ban---
By Daily Mail Reporter
Last updated at 12:53 AM on 17th November 2010
http://www.dailymail.co.uk/money/article-1330301/Fears-genetic-test-insurers-review-voluntary-ban.html?ito=feeds-newsxml

Life insurers will review their voluntary ban on using genetic test results next year.

If someone takes a test and finds they might contract a disease, they do not currently have to declare this to their insurer, as the industry is disregarding genetic testing until 2014.

However, campaigners are worried that when this decision is reviewed in 2011, insurers will abandon the agreement and use genetic testing as an excuse to ‘cherry pick’ customers from 2014.

Last week, the Mail revealed that scientists are developing a test for people in their 40s to spot signs of Alzheimer’s.

Similar tests for breast cancer, Huntington’ s disease and Cystic fibrosis are already available.

Ruth Sutherland, of the Alzheimer’s Society, says: ‘Allowing insurers to discriminate against people with a known genetic predisposition is unfair.’

The European Convention of Human Rights, states: ‘Discrimination against a person on grounds of genetic heritage is prohibited.’

Ms Sutherland, says: ‘We want this to be enshrined in law, instead of having a voluntary agreement.’

A spokeswoman for the Association of British insurers, says: ‘Insurers will not ask anyone to undergo a genetic test to get insurance. However, insurers do take into account family illness, so people can notify us if they found they did not have a genetic propensity to a certain illness.

‘We regularly review the moratorium, as medical discoveries are happening all the time.’


---EEOC issues final regulations on genetic discrimination in the workplace---
Kilpatrick Stockton LLP
Thomas H. Christopher, Louis W. Doherty and David C. Lindsay
USA
November 10 2010
http://www.lexology.com/library/detail.aspx?g=cf492682-b9aa-40fc-90ac-3947faef91c0

On November 9, 2010, the Equal Employment Opportunity Commission (“EEOC”) published its long-delayed final regulations interpreting the employment-related provisions of the Genetic Information Nondiscrimination Act (“GINA”), a federal law that went into effect for employers on November 21, 2009. GINA prohibits employers from discriminating in employment on the basis of genetic information (including family medical history) and restricts the acquisition and disclosure of genetic information by employers. The new regulations provide guidance for employers on the practical application of GINA’s provisions and establish new rules that employers should follow in obtaining health-related information about employees and their family members. Highlights of these regulations are discussed below.

The New GINA Regulations

The employment-related provisions of GINA apply generally to employers with fifteen or more employees, as well as to most federal and state governmental offices, regardless of size. Although GINA’s provisions expressly protect employees and applicants, the new regulations clarify that GINA protects former employees as well. For example, GINA would prohibit an employer from disclosing genetic information about a former employee to a prospective employer of that individual.

GINA prohibits employers from discriminating in employment on the basis of genetic information and from limiting, segregating, or classifying employees on the basis of such information. The regulations clarify that an employer will not violate these provisions when its actions are required by a law or regulation mandating genetic monitoring, such as certain regulations issued under the Occupational Safety and Health Act. Moreover, although GINA does not expressly refer to harassment, the EEOC takes the position that GINA’s nondiscrimination provision prohibits workplace harassment based on genetic information.

The provision of GINA likely to have the most immediate and widespread impact on employers is the general prohibition against acquiring genetic information about applicants and employees. GINA broadly defines “genetic information” as information about the genetic tests of an applicant/employee or of the applicant/employee’s family members, information about a request for or receipt of genetic services by an applicant/employee or his or her family members, and information about the manifestation of a disease or disorder of the applicant/employee’s family members. Thus, GINA generally prohibits employers from acquiring an applicant/employee’s family medical history, including any information about a family member’s disease or disorder. The regulations define “family members” as dependents who are or become related to an applicant or employee through marriage, birth, adoption, or placement for adoption and any blood relative within four degrees of relationship to an applicant or employee (that is, as far removed as a great-great-grandparent). The inclusion of persons who are not blood relatives of an applicant or employee may seem odd because they share no inherited genes with the applicant/employee, but the EEOC reasoned that an employer could discriminate against an employee based on the genetic information of a spouse or adopted child out of fear that the family member’s condition could run up health insurance costs. The new regulations note that information about race and ethnicity that is not derived from a genetic test is not genetic information under GINA. Thus, employers may continue to invite applicants and employees to identify their race and ethnicity for applicant-flow and affirmative action purposes without running afoul of GINA.

GINA’s restrictions on acquiring genetic information generally bar employers from requesting such information. The EEOC takes the position that requests for genetic information are not limited to inquiries directed to an applicant, employee, or health care provider, however. The regulations state that a request for genetic information includes conducting an Internet search on an individual in a way that is likely to produce results containing genetic information. For example, running an Internet search linking an individual’s name with a particular genetic trait would constitute a prohibited request for genetic information.

GINA contains a number of exceptions to its general prohibition against acquiring genetic information, and the new regulations address these exceptions in detail. One of the exceptions provides that an employer does not violate GINA when it inadvertently acquires information about family medical history. The EEOC takes the position that this exception applies to the inadvertent acquisition of any type of genetic information about an applicant/employee or his or her family members and not just genetic information in the form of family medical history. The regulations provide several examples of situations in which genetic information may be inadvertently acquired. For example, the exception applies to genetic information disclosed in response to an employer’s casual question about an individual’s general well-being (“How is your son feeling today?”) and to genetic information disclosed by an employee or applicant without any solicitation by the employer. When an employer inadvertently acquires genetic information in this manner, however, it may not ask follow-up questions that probe for genetic information (for example, “Do other family members have the condition?”). Similarly, the exception for inadvertently acquired information will ordinarily apply to genetic information that a manager or supervisor learns while reviewing a social networking profile that the manager or supervisor has permission to access, but if a manager or supervisor accesses a social networking site, even with permission, for the purpose of acquiring genetic information, the exception would not apply.

When an employer legitimately seeks health-related information in connection with employment (such as information relating to a request for a leave of absence or for reasonable accommodation of a disability), the employer may sometimes receive genetic information in response, even though the request did not specifically seek such information. The new regulations create a “safe harbor” to ensure that such genetic information will be deemed inadvertently acquired. This “safe harbor” will apply when the employer warns the person from whom it seeks health-related information not to provide genetic information, and the regulations provide sample language to use in giving that warning. Although failure to give the warning ordinarily will not preclude an employer from arguing that genetic information was inadvertently acquired, the EEOC takes the position that a warning is mandatory when an employer engages a health care professional to conduct any type of employment-related medical examination because the health care professional could be expected to acquire genetic information (for example, family medical history) in the absence of a warning. Moreover, the regulations provide that when a health care professional is engaged by an employer to determine an individual’s ability to perform a job, the employer must direct the health care professional not to collect genetic information as part of the examination.

Another statutory exception to the general prohibition against acquiring genetic information permits employers to acquire such information when they offer employees health or genetic services (such as a wellness program), provided the disclosure of genetic information by participating employees is voluntary, participating employees give voluntary written authorizations relating to genetic information, and certain safeguards are in place. In connection with these programs, the new regulations allow employers to offer certain financial inducements to participate in health or genetic services as long as employers do not offer inducements to disclose genetic information. For example, if an employer offers inducements to employees to complete a health assessment form including questions about family medical history, the employer must specifically identify the questions seeking genetic information and make it clear that employees need not answer those particular questions to receive the inducement.

GINA also provides an exception permitting the acquisition of genetic information (typically, family medical history) in connection with a request for leave to care for a family member with a serious health condition under the Family and Medical Leave Act or a similar state or local law. The regulations add that this exception also applies to employers that are not covered by a leave law but that have a uniformly applied policy granting leaves to care for ill family members. The regulations remind employers that family medical information obtained in connection with a leave request constitutes confidential genetic information under GINA and must be kept in a medical file separate from the employee’s general personnel file.

Another statutory exception to GINA’s general prohibition against the acquisition of genetic information applies to the purchase of commercially and publicly available materials that may include family medical history. The regulations interpret this exception as applying to the acquisition of any type of genetic information (not just family medical history), whether by purchase or otherwise, from commercially and publicly available materials. According to the regulations, this exception applies to genetic information acquired from newspapers, magazines, books, television, movies, and certain Internet resources. With respect to Internet resources, the regulations provide that the exception does not apply to media sources that require permission for access from a particular individual or membership in a particular group such as a professional organization, as those sources would not be considered commercially and publicly available. The mere fact that a website requires visitors to acquire a user name and/or password does not take the site outside the scope of the exception, however. Even when a website or other information source is commercially and publicly available, the regulations state that the exception does not apply when an employer accesses the information source for the purpose of acquiring genetic information.

The new regulations address additional topics relating to GINA, including confidentiality requirements, permissible disclosures of genetic information, and the relationship of GINA to other federal laws such as the Americans with Disabilities Act and the Health Insurance Portability and Accountability Act (“HIPAA”).

Practical Implications

The foregoing discussion summarizes only those aspects of the new GINA regulations that are likely to have the most immediate impact on employers. In light of these regulations, employers should consider taking the following proactive steps to avoid liability under GINA:

* Train managers and supervisors about what constitutes genetic information under GINA. The broad definition of “genetic information,” which includes information about a disease or disorder that any member of an employee’s extended family has, can be a trap for the unwary.
* Train managers and supervisors about GINA’s general prohibitions against acquiring and disclosing genetic information. Although a casual inquiry about the well-being of an employee’s relative is permissible, follow-up questions seeking more information about any disease the relative might have may violate GINA, even if asked innocently out of genuine curiosity or concern.
* Implement procedures to ensure genetic information legitimately acquired by the employer is maintained in confidential medical files separate from the general personnel files. Most employers are well-acquainted with the Americans with Disabilities Act’s requirement that medical information about employees be maintained in separate confidential medical files, but GINA adds the requirement that medical information about relatives of an employee also be kept in such files. This would include, for example, medical information about an employee’s family member acquired in connection with a request for family and medical leave. Although the new regulations do not require employers to purge personnel files of genetic information acquired before the effective date of GINA, employers would be prudent to do so to prevent managers and supervisors from having access to genetic information that could be used to discriminate against employees in violation of GINA and to prevent an inadvertent disclosure of genetic information.
* Employers should modify any forms they use seeking health-related information (for example, medical certification forms used in connection with leave requests and directions for health care providers performing post-offer, preemployment medical examinations) to add appropriate warnings against disclosing genetic information. Similarly, employers that sponsor employee wellness programs offering inducements for completing a health-assessment form should ensure that the form clearly identifies the questions seeking genetic information and states that employees need not answer those questions to receive the inducement.


---遺伝子検査ビジネスご注意 学会警鐘「根拠あいまい」---
2010年10月29日12時57分
http://www.asahi.com/health/news/TKY201010290205.html

 ほおの粘膜や髪の毛のDNAを調べれば、肥満や薄毛の危険度から病気、知能、将来の進路まで判定できるとPRする遺伝子検査ビジネスが急増している。日本人類遺伝学会は29日、科学的な根拠、有用性がはっきりしないとして、専門家による検証や国による監督の体制作りを急ぐべきだとする提言をまとめた。
 遺伝子検査ビジネスの市場規模は近年、急拡大している。経済産業省が昨年度まとめた調査結果では、2007年の市場規模は9億円。「ここ数年は毎年2ケタ成長が予想されている」という。インターネットなどで遺伝子検査をうたう美容整形クリニックや、健康食品会社、遺伝子情報サービス会社は今年の2月時点で200以上あったという。ダイエット関係が7割を占めている。
 ほおの粘膜の細胞から、肥満などの可能性を調べるという検査の費用は5千円程度。ダイエットを目的に、個人に合った健康補助食品や食生活、運動法が分かるとPRしている健康食品会社もある。
 トラブルも起き始めた。国民生活センターには、がんの遺伝子検査を受けたという70代の男性から相談があった。相談内容によると、男性は09年、病院でがんに関係する遺伝子検査を受け、40万円を支払った。検査結果は「がんに関係する遺伝子はない」。しかし、数カ月後に肺がんと診断されたという。同センターには、630万円を前払いしたのに、遺伝子検査をしないといった別の相談もあったという。
 これに対し、日本人類遺伝学会は29日、専門家による第三者の検証機関の創設、法整備などを求める見解案をまとめた。同学会は「検査ビジネスはあたかも病気、能力、性格、進路の適性を確実に予測できるかのように誤解を与えている場合も少なくない」と判断している。また、子どもが遺伝子検査を受けることについて、結果を知り将来の夢をあきらめたり、遺伝子による差別が起きたりしかねないと心配している。
 遺伝子検査に関係する法律は国内にはないが、海外では整備されつつある。経産省の調査によると、韓国では05年に遺伝学的検査の質の保証と、遺伝子差別の禁止を定めた法律が施行された。子どもの受験競争が激しい韓国では、ベンチャー企業が「子どもの潜在的な特性や個性を磨き、補完できる」とPRし、子ども向けの検査ビジネスが過熱したためだ。
 遺伝子検査が盛んな米国でも08年、個人情報の保護を目的に遺伝情報による差別を禁止する法律が制定された。遺伝情報で医療保険に差をつけることが懸念されたのが一因だ。(杉本崇)

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