Tappava Lääketiede osa 2 - Death by Medicine part 2; Medical Ethics and Conflict of Interest in Scientific Medicine

Tappava Lääketiede osa 2/4 - Death by Medicine part 2 of 4;  

Medical Ethics and Conflict of Interest in Scientific Medicine

Lääketieteen etiikka ja eturistiriidat tieteellisessä tutkimuksessa
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD
lyhentäen kääntänyt Riikka Söyring
Jonathan Quick, director of essential drugs and medicines policy for the World Health Organization (WHO), wrote in a recent WHO bulletin: "If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken."(19)
Jonathan Quick (WHO:n johtaja, joka vastaa lääkepolitiikasta) kirjoitti: "Jos kliininen tutkimus muuttuu kaupalliseksi yritykseksi, jossa oma etu ohittaa yhteisen edun ja himo/ahneus tieteen, silloin sosiaalinen sopimus mikä sallii kokeet ihmisten kanssa vastineeksi lääketieteellisestä avusta on rikottu" (suom.huom: Kuinkahan juolahti mieleeni THL, Pandemrix-sikainfluenssarokote, Gardasil-HPV-rokote, AH5N1-rokote jota seuraavaksi tyrkytetään? Kumma juttu).
As former editor of the New England Journal of Medicine , Dr. Marcia Angell struggled to bring greater attention to the problem of commercializing scientific research. In her outgoing editorial entitled “ Is Academic Medicine for Sale?” Angell said that growing conflicts of interest are tainting science and called for stronger restrictions on pharmaceutical stock ownership and other financial incentives for researchers:(20) “When the boundaries between industry and academic medicine become as blurred as they are now, the business goals of industry influence the mission of medical schools in multiple ways.” She did not discount the benefits of research but said a Faustian bargain now existed between medical schools and the pharmaceutical industry.
Entinen New England Journal of Medicinen päätoimittaja Tri Marcia Angell kutsuu tutkijoiden ja lääkeyhtiöiden sopimuksia "Faustin sopimuksiksi" : "Kasvava joukko eturistiriitoja ja jääviysongelmia tahraavat tieteen, tarvitaan tiukempaa sääntelyä."
Angell left the New England Journal in June 2000. In June 2002, the New England Journal of Medicine announced that it would accept journalists who accept money from drug companies because it was too difficult to find ones who have no ties. Another former editor of the journal, Dr. Jerome Kassirer, said that was not the case and that plenty of researchers are available who do not work for drug companies.(21) According to an ABC news report, pharmaceutical companies spend over $2 billion a year on over 314,000 events attended by doctors.
Angell lähti vuonna 2000. Vuonna 2002 the New England Journal of Medicine ilmoitti hyväksyvänsä lääkeyhtiöiltä rahaa ottavia toimittajia, koska oli liian vaikeaa löytää ihmisiä vailla kytköksiä ja kahleita.
http://www.rokotusinfo.fi/  kts. kohdasta Uutisvirta; uutisia koottuna maailman mediasta
The ABC news report also noted that a survey of clinical trials revealed that when a drug company funds a study, there is a 90% chance that the drug will be perceived as effective whereas a non-drug-company-funded study will show favorable results only 50% of the time. It appears that money can't buy you love but it can buy any "scientific" result desired.
ABC-uutiset raportoi, että kliinisten julkaisujen tarkastelu osoittaa että lääkeyhtiö rahoittaa tutkimuksen on 90% mahdollisuus, että tutkittava lääke todetaan tehokkaaksi kun taas ei-lääkeyhtiöllä vastaava luku on 50%.
Cynthia Crossen, a staffer for the Wall Street Journal, i n 1996 published Tainted Truth : The Manipulation of Fact in America , a book about the widespread practice of lying with statistics.(22) Commenting on the state of scientific research, she wrote: “The road to hell was paved with the flood of corporate research dollars that eagerly filled gaps left by slashed government research funding.” Her data on financial involvement showed that in l981 the drug industry “gave” $292 million to colleges and universities for research. By l991, this figure had risen to $2.1 billion.
Cynthia Crossen, Wall Street Journal, julkaisi 1996 kirjan Tainted Truth: The Manipulation of Fact in America (Tahrattu Totuus: Faktojen Manipulointi Amerikassa). Kirja kertoo laajasti harjoitetusta valehtelusta tilastojen avulla. Cynthia Crossen kommentoi tieteellistä tutkimusta seuraavasti: "Tie helvettiin oli kivetty yhtiöidern tutkimusdollareilla, joilla innokkaasti ja ahneesti täytettiin aukkoja valtion rahoituksessa." Cynthia Crossen esitti kirjassaan dataa siitä, että 1981 lääkeyhtiöt "antoivat rahaa tutkimukseen 292 miljoonaa dollaria yliopistoille ja tutkimuslaitoksille. Vuonna 1991 summa oli noussut jo 2,1 miljardiin dollariin."

THE FIRST IATROGENIC STUDY

ENSIMMÄINEN TUTKIMUS HOITOVIRHEISTÄ
Dr. Lucian L. Leape opened medicine's Pandora's box in his 1994 paper, “Error in Medicine,” which appeared in the Journal of the American Medical Association (JAMA).(16) He found that Schimmel reported in 1964 that 20% of hospital patients suffered iatrogenic injury, with a 20% fatality rate. In 1981 Steel reported that 36% of hospitalized patients experienced iatrogenesis with a 25% fatality rate, and adverse drug reactions were involved in 50% of the injuries. In 1991, Bedell reported that 64% of acute heart attacks in one hospital were preventable and were mostly due to adverse drug reactions.
Tri Lucian L. Leape avasi lääketieteen Pandoran lippaan vuonna 1994 kirjoituksellaan "Lääketieteen Erheet", joka ilmestyi Journal of the American Medical Association-lehdessä (JAMA). Hän sai selville, että Schimmel raportoi vuonna 1964 että 20% sairaalapotilaista kärsi hoitovirheistä. Vuonna 1981 Steel raportoi, että 36% potilaista kärsi hoitovirheistä ja että kohtalokkaita seurauksia kärsi 25%. Lääkkeiden haittavaikutukset olivat osallisina 50% tapauksia. Vuonna 1991 Bedell raportoi että 64% akuuteista sydänkohtauksista yhdessä sairaaloista olisivat olleet estettävissä ja johtuivat pääosin lääkkeiden haittavaikutuksista.
Leape focused on the “Harvard Medical Practice Study” published in 1991, (16a) which found a 4% iatrogenic injury rate for patients, with a 14% fatality rate, in 1984 in New York State. From the 98,609 patients injured and the 14% fatality rate, he estimated that in the entire U.S. 180,000 people die each year partly as a result of iatrogenic injury.
Leape keskittyi "Harvard Medical Practise Study"-tutkimukseen, julkaistu 1991, jonka mukaan 4% hoitovirheistä johti 14 prosentissa kohtalokkaisiin seurauksiin vuonna 1984 New Yorkin osavaltiossa. Hän arvioi tutkimuksen perusteella (98,609 vammautunutta potilasta/ 14% kohtalokkain seurauksin) että USAssa kuolee vuosittain 180,000 ihmistä osittain hoitovirheiden takia.
Why Leape chose to use the much lower figure of 4% injury for his analysis remains in question. Using instead the average of the rates found in the three studies he cites (36%, 20%, and 4%) would have produced a 20% medical error rate. The number of iatrogenic deaths using an average rate of injury and his 14% fatality rate would be 1,189,576.
Miksi Leape käytti tuota matalaa 4% lukua analyysissaan, on arvoitus. Jos hän olisi käyttänyt keskiarvoa siteeraamistaan tutkimuksista (36%, 20% ja 4%), hän olisi päätynyt paljon korkeampaan lukuun so. 20% keskiarvo hoitovirheissä. Tällöin hän olisi saanut tulokseksi 1,189,576 henkilöä vuodessa.
Leape acknowledged that the literature on medical errors is sparse and represents only the tip of the iceberg, noting that when errors are specifically sought out, reported rates are “distressingly high.” He cited several autopsy studies with rates as high as 35-40% of missed diagnoses causing death. He also noted that an intensive care unit reported an average of 1.7 errors per day per patient, and 29% of those errors were potentially serious or fatal.
Leape myönsi, että kirjallisuus hoitovirheistä oli vähäistä ja edustaa vain jäävuoren huippua. Hän huomauttaa myös, että kun virheet etsitään ja nostetaan tarkasteltaviksi, raportoitujen hoitovirhetapausten lukumäärä on kauhistuttavan korkea.
Leape siteeraa useita ruumiinavaustutkimuksia, joissa luvut ovat niinkin korkeat kuin 35-40%. Hän mainitsee myös, että Ensiavun raporttien mukaan virheitä tapahtuu keskimäärin 1.7 virhettä/potilas/päivä ja että 29% virheistä oli kohtalokkaita.      (suom.huom. Ei ihme, että Tarja Halonen siirsi ruumiinavaukset THL:lle erikoismääräyksellä 11.12 2009 kesken kuumimman H1N1-"pandemia"pelottelun! Kyllä tuollaiset lukemat jo vaativat sitä, että autovaras tutkii itse, onko syyllistynyt varkauteen, ja epäilemättä antaa vapauttavan päätöksen itselleen)
Leape calculated the error rate in the intensive care unit study. First, he found that each patient had an average of 178 “activities” (staff/procedure/medical interactions) a day, of which 1.7 were errors, which means a 1% failure rate. This may not seem like much, but Leape cited industry standards showing that in aviation, a 0.1% failure rate would mean two unsafe plane landings per day at Chicago's O'Hare International Airport; in the US Postal Service, a 0.1% failure rate would mean 16,000 pieces of lost mail every hour; and in the banking industry, a 0.1% failure rate would mean 32,000 bank checks deducted from the wrong bank account.
Leape laski hoitovirhelukemat/päivä Ensiavussa: joka potilas oli keskimäärin noin 178 erilaisen "aktiviteetin" kohteena per päivä, joista 1,7 oli erheellisiä ja vaaraa aiheuttavia. Epäonnistumislukemaksi tuli 1%. Se ei kuulosta paljolta, mutta kun sitä vertaa esim. ilmailuun, niin 0,1% virhe päivässä tuottaisi 2 vaarallista laskeutumista Chicagon O´Hare-lentokentälle. Postissa se tekisi 16 kadonnutta lähetystä per tunti, pankissa 0,1% virhe tarkoittaisi 32 shekkiä veloitettuna vääriltä tileiltä.
In trying to determine why there are so many medical errors, Leape acknowledged the lack of reporting of medical errors. Medical errors occur in thousands of different locations and are perceived as isolated and unusual events. But the most important reason that the problem of medical errors is unrecognized and growing, according to Leape, is that doctors and nurses are unequipped to deal with human error because of the culture of medical training and practice. Doctors are taught that mistakes are unacceptable. Medical mistakes are therefore viewed as a failure of character and any error equals negligence. No one is taught what to do when medical errors do occur. Leape cites McIntyre and Popper, who said the “infallibility model” of medicine leads to intellectual dishonesty with a need to cover up mistakes rather than admit them. There are no Grand Rounds on medical errors, no sharing of failures among doctors, and no one to support them emotionally when their error harms a patient.
Yrittäessään selvittää, miksi tapahtuu niin paljon hoitovirheitä, Leape kiinnitti huomiota raportoimattomuuteen. Hoitovirheet tapahtuvat tuhansissa yhteyksissä eri tilanteissa ja eri paikoissa. Niitä tarkastellaan erillisinä ja epätavallisina ilmiöinä. Tärkein syy hoitovirheiden lisääntymiseen Leapen mukaan on kuitenkin se, että lääkärit ja hoitajat ovat kykenemättömiä käsittelemään inhimillisiä erehdyksiä, ja että tämä johtuu lääketieteellisestä koulutuksesta ja käytännöstä. Lääkäreillä opetetaan, että virheitä ei suvaita. Virheitä tarkastellaan tämän takia henkilökohtaisina epäonnistumisina ja joka virhe rinnastetaan laiminlyöntiin. Kenellekään ei opeteta, miten toimia kun virheitä tapahtuu. Leape siteeraa McIntyrea ja Popperia, jotka sanoivat että  lääketieteen "erehtymättömyys-malli" johtaa älylliseen epärehellisyyteen ja tarpeeseen mieluummin peitellä virheet kuin myöntää ne. Ei ole olemassa mitään mallia, jossa epäonnistumiset jaetaan ja niistä otetaan opiksi. (suom.huom. Väistämätön assosiaatio politiikkaan ja THL:n toimintaa iski)
Leape hoped his paper would encourage medical practitioners “to fundamentally change the way they think about iatrogenic errors and why they occur.” It has been almost a decade since this groundbreaking work, but the mistakes continue to soar.
Leape toivoi, että hänen raporttinsa rohkaisisi lääketieteen harjoittajia "perusteellisesti muuttamaan ajattelutapojaan hoitovirheistä ja siitä, miksi niitä ilmenee". On kulunut vuosikymmen tämän uriauurtavan tutkimuksen julkaisemisesta, mutta mikään ei ole muuttunut, hoitovirheet vain lisääntyvät.
In 1995, a JAMA report noted, "Over a million patients are injured in US hospitals each year, and approximately 280,000 die annually as a result of these injuries. Therefore, the iatrogenic death rate dwarfs the annual automobile accident mortality rate of 45,000 and accounts for more deaths than all other accidents combined."(23)
JAMA 1995: hoitovirhekuolemien rinnalla autokolarien ja muiden onnettomuuksien yhteenlasketut uhrit jäävät kauas taa.
At a 1997 press conference, Leape released a nationwide poll on patient iatrogenesis conducted by the National Patient Safety Foundation (NPSF), which is sponsored by the American Medical Association (AMA). Leape is a founding member of NPSF. The survey found that more than 100 million Americans have been affected directly or indirectly by a medical mistake. Forty-two percent were affected directly and 84% personally knew of someone who had experienced a medical mistake.(14)
1997: 42% oli itse kokenut hoitovirheitä, 84% tunsi henkilökohtaisesti jonkun hoitovirheen uhrin
At this press conference, Leape updated his 1994 statistics, noting that as of 1997, medical errors in inpatient hospital settings nationwide could be as high as 3 million and could cost as much as $200 billion . Leape used a 14% fatality rate to determine a medical error death rate of 180,000 in 1994.(16) In 1997, using Leape's base number of 3 million errors, the annual death rate could be as high as 420,000 for hospital inpatients alone.

ONLY A FRACTION OF MEDICAL ERRORS ARE REPORTED

VAIN MURTO-OSA HOITOVIRHEISTÄ KIRJATAAN
In 1994, Leape said he was well aware that medical errors were not being reported.(16) A study conducted in two obstetrical units in the UK found that only about one-quarter of adverse incidents were ever reported, to protect staff, preserve reputations, or for fear of reprisals, including lawsuits.(24). An analysis by Wald and Shojania found that only 1.5% of all adverse events result in an incident report, and only 6% of adverse drug events are identified properly. The authors learned that the American College of Surgeons estimates that surgical incident reports routinely capture only 5-30% of adverse events. In one study, only 20% of surgical complications resulted in discussion at morbidity and mortality rounds.(25) From these studies, it appears that all the statistics gathered on medical errors may substantially underestimate the number of adverse drug and medical therapy incidents. They also suggest that our statistics concerning mortality resulting from medical errors may be in fact be conservative figures.
Leape sanoi vuonna 1994 olevansa tietoinen siitä, että vain murto-osa hoitovirheistä kirjataan. Syitä ovat mm. henkilökunnan suojeleminen, maineen säilyttäminen ja seurausten -kuten esim. syytteiden- pelko. Wald ja Shojania selvittivät, että vain 1,5% hoitovirheistä ja 6% lääkkeiden haittavaikutuksista raportoidaan.
- - - - - Tutkimuksista selvisi, että tilastojen luvut ovat karkeasti alakanttiin.
An article in Psychiatric Times (April 2000) outlines the stakes involved in reporting medical errors.(26) The authors found that the public is fearful of suffering a fatal medical error, and doctors are afraid they will be sued if they report an error. This brings up the obvious question: who is reporting medical errors? Usually it is the patient or the patient's surviving family. If no one notices the error, it is never reported. Janet Heinrich, an associate director at the U.S. General Accounting Office responsible for health financing and public health issues, testified before a House subcommittee hearing on medical errors that "the full magnitude of their threat to the American public is unknown” and "gathering valid and useful information about adverse events is extremely difficult." She acknowledged that the fear of being blamed, and the potential for legal liability, played key roles in the underreporting of errors. The Psychiatric Times noted that the AMA strongly opposes mandatory reporting of medical errors.(26) If doctors are not reporting, what about nurses? A survey of nurses found that they also fail to report medical mistakes for fear of retaliation.(27)
Artikkeli Psychiatric Times-lehdessä (huhtik.2000): asiakkaat pelkäävät joutuvansa kohtalokkaan hoitovirheen uhriksi, ja lääkärit pelkäävät joutuvansa syytteeseen jos he raportoivat hoitovirheen.
Kuka sitten raportoi hoitovirheistä?
Yleensä potilas itse, tai hänen surevat omaisensa. Jos kukaan heistä ei huomaa hoitovirhettä, hoitovirhettä ei koskaan raportoida. - - - - - - - -  AMA (Amerikan Lääkärien Yhdistys) vastustaa ankarasti pakollista hoitovirheistä raportointia.
Jos lääkärit eivät raportoi, kuinka hoitajat? Kysely paljasti, että hoitajatkaan eivät raportoi hoitovirheistä.
Standard medical pharmacology texts admit that relatively few doctors ever report adverse drug reactions to the FDA.(28) The reasons range from not knowing such a reporting system exists to fear of being sued.(29) Yet the public depends on this tremendously flawed system of voluntary reporting by doctors to know whether a drug or a medical intervention is harmful.
Standarditekstit lääketieteellisestä farmakologiasta myöntävät että varsin harvat lääkärit koskaan raportoivat lääkkeiden haittavaikutuksista. Syyt vaihtelevat; moni ei edes tiedä ilmoittamiskäytännön olemassaolosta; toiset pelkäävät saavansa nuhteita. Kuitenkin yleisö on täysin riippuvainen tästä surkeasta käytännöstä, joka perustuu vapaaehtoisuuteen ilmoitusten tekemisessä!
Pharmacology texts also will tell doctors how hard it is to separate drug side effects from disease symptoms. Treatment failure is most often attributed to the disease and not the drug or doctor. Doctors are warned, “Probably nowhere else in professional life are mistakes so easily hidden, even from ourselves.”(30) It may be hard to accept, but it is not difficult to understand why only 1 in 20 side effects is reported to either hospital administrators or the FDA.(31, 31a)
Farmakologian tekstit kertovat lääkäreille myös, että on vaikea erottaa lääkkeen haittavaikutuksia sairauden oireista. Hoitovirhe pannaan useimmiten sairauden, ei lääkärin tai lääkkeen syyksi. Lääkäreille kerrotaan "Luultavasti missään muussa ammatissa ei virheitä ole yhtä helppo piilottaa, myös itseltämme." Vain yksi kahdestakymmenestä haittavaikutuksesta koskaan ilmoitetaan eteenpäin joko sairaalan johdolle taikka FDAlle (Lääkevirasto).
If hospitals admitted to the actual number of errors for which they are responsible, which is about 20 times what is reported, they would come under intense scrutiny.(32) Jerry Phillips, associate director of the FDA's Office of Post Marketing Drug Risk Assessment, confirms this number. “In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur.”(33) Dr. Jay Cohen, who has extensively researched adverse drug reactions, notes that because only 5% of adverse drug reactions are reported, there are in fact 5 million medication reactions each year.(34)
Jos sairaalat myöntäisivät virheiden todellisen määrän, ne joutuisivat ankaran tarkastelun alaisiksi. - - - - Vuosittain ilmoitetut 250 000 haittavaikutusta ovat vain noin 5% todellisesta määrästä. Tri Jay Cohenin mukaan: jos vain noin 5% todellisista haittavaikutuksista ilmoitetaan, on todellisuudessa silloin noin 5 miljoonaa haittavaikutusta vuosittain.
A 2003 survey is all the more distressing because there seems to be no improvement in error reporting, even with all the attention given to this topic. Dr. Dorothea Wild surveyed medical residents at a community hospital in Connecticut and found that only half were aware that the hospital had a medical error-reporting system, and that the vast majority did not use it at all. Dr. Wild says this does not bode well for the future. If doctors don't learn error reporting in their training, they will never use it. Wild adds that error reporting is the first step in locating the gaps in the medical system and fixing them. Not even that first step has been taken to date.(35)
Vuoden 2003 tutkimus osoitti, että vain puolet Connecticutilaisen sairaalan henkilökunnasta tiesi haittavaikutusilmoituskäytännön olemassaolosta, ja että suurin osa ei käyttänyt sitä koskaan. Tämä ei lupaa hyvää tulevaisuudelle. Jos lääkärit eivät opi raportoimaan haittavaikutuksista koulutuksensa aikana, he eivät koskaan tee sitä. Vain tekemällä ilmoituksia, voidaan aukot järjestelmässä paikata, Tri Dorothea Wild sanoo.
Askeltakaan siihen suuntaan ei ole tähän päivään mennessä otettu.

PUBLIC SUGGESTIONS ON IATROGENESIS

In a telephone survey, 1,207 adults ranked the effectiveness of the following measures in reducing preventable medical errors that result in serious harm.(36) (Following each measure is the percentage of respondents who ranked the measure as “very effective.”)

• giving doctors more time to spend with patients (78%)    lääkäreille enemmän aikaa potilasta kohti
• requiring hospitals to develop systems to avoid medical errors (74%)  sairaaloita tulisi vaatia kehittämään käytäntöjä
• better training of health professionals (73%)   terveydenhuoltohenkilökunnan parempi koulutus
• using only doctors specially trained in intensive care medicine on intensive care units (73%)  Ensiavussa vain erikoiskoulutettua henkilökuntaa
• requiring hospitals to report all serious medical errors to a state agency (71%)  sairaaloita tulisi vaatia (lakisääteisesti) ilmoittamaan haittavaikutuksista ja hoitovirheistä
• increasing the number of hospital nurses (69%)  lisäämällä hoitajien lukumäärää
• reducing the work hours of doctors in training to avoid fatigue (66%)  vähentämällä lääkärien työtunteja
• encouraging hospitals to voluntarily report serious medical errors to a state agency (62%).   rohkaisemalla henkilökuntaa vapaaehtoisesti raportoimaan vakavista haittavaikutuksista viranomaisille

jatkuu...katso Tappava Lääketiede osa 3 - continues...see Death by Medicine part 3     

alla liitteet:

OFFICE OF TECHNOLOGY ASSESSMENT (OTA)

Health Care Technology and Its Assessment in Eight Countries, 1995.

General Facts

1. In 1990, US life expectancy was 71.8 years for men and 78.8 years for women, among the lowest rates in the developed countries.
2. The 1990 US infant mortality rate in the US was 9.2 per 1,000 live births, in the bottom half of the distribution among all developed countries.
3. Health status is correlated with socioeconomic status.
4. Health care is not universal.
5. Health care is based on the free market system with no fixed budget or limitations on expansion.
6. Health care accounts for 14% of the US GNP ($800 billion in 1993).
7. The federal government does no central planning, though it is the major purchaser of health care for older people and some poor people.
8. Americans are less satisfied with their health care system than people in other developed countries.
9. US medicine specializes in expensive medical technology; some large US cities have more magnetic resonance image (MRI) scanners than most countries.
10. Huge public and private investments in medical research and pharmaceutical development drive this “technological arms race.”
11. Any efforts to restrain technological developments in health care are opposed by policymakers concerned about negative impacts on medical-technology industries.

Hospitals

1. In 1990, the US had 5,480 acute-care hospitals, 880 specialty (psychiatric, long-term care, and rehabilitation) hospitals, and 340 federal (military, veterans, and Native American) hospitals, or 2.7 hospitals per 100,000 population.
2. In 1990, the average length of stay for 33 million admissions was 9.2 days. The bed occupancy rate was 66%. Lengths of stay were shorter and admission rates lower than other countries.
3. In 1990, the US had 615,000 physicians, or 2.4 per 1,000 population; 33% were primary care (family medicine, internal medicine, and pediatrics) and 67% were specialists.
4. In 1991, government-run health care spending totaled $81 billion.
5. Total US health care spending rose to $752 billion in 1991 from $70 billion in 1950. Spending grew five-fold per capita.
6. Reasons for increased healthcare spending include:
   1. The high cost of defensive medicine, with an escalation in services solely to avoid malpractice litigation.
   2. US health care based on defensive medicine costs nearly $45 billion per year, or about 5% of total health care spending, according to one source.
   3. The availability and use of new medical technologies have contributed the most to increased health care spending, argue many analysts. These costs are impossible to quantify.

Health-Related Research and Development

1. The US spends more than any other country on health-related R&D.
2. In 1989, the federal government spent $9.2 billion on R&D, while private industry spent an additional $9.4 billion.
3. Total US R&D expenditures rose 50% from 1983 to 1992.
4. NIH receives about half of US government R&D funding.
5. NIH spent more on basic research ($4.1 billion in 1989) than for clinical trials of medical treatments on humans ($519 million in 1989).
6. Most of the clinical trials evaluate new treatment protocols for cancer and complications of AIDS, and do not study existing treatments, even though their effectiveness is in many cases unknown and questionable.
7. In 1990, the NIH had just begun to do meta-analysis and cost-effectiveness analysis.

Pharmaceutical and Medical-Device Industries

1. About two-thirds of the industry's $9.4 billion budget went to drug research; device manufacturers spent the remaining one-third.
2. In addition to R&D, the medical industry spent 24% of total sales on promoting their products and 15% of total sales on development.
3. Total marketing expenses in 1990 were over $5 billion.
4. Many products provide no benefit over existing products.
5. Public and private health care consumers buy these products.
6. If health care spending is perceived as a problem, a highly profitable drug industry exacerbates the problem.

Controlling Health Care Technology

1. The FDA ensures the safety and efficacy of drugs, biologics, and medical devices.
2. The FDA does not consider costs of therapy.
3. The FDA does not consider the effectiveness of a therapy.
4. The FDA does not compare a product to currently marketed products
5. The FDA does not consider nondrug alternatives for a given clinical problem.
6. It costs $200 million in development costs to bring a new drug to market. AIDS-drug interest groups forced new regulations that speed up the approval process.
7. Such drugs should be subject to greater post-marketing surveillance requirements. As of 1995, these provisions had not yet come into play.
8. Many argue that reductions in the pre-approval testing of drugs open the possibility of significant undiscovered toxicities.

Health Care Technology Assessment

1. Failure to evaluate technology was a focus of a 1978 report from OTA with examples of many common medical practices supported by limited published data (10-20%).
2. In 1978, Congress created the National Center for Health Care Technology (NCHCT) to advise Medicare and Medicaid.
3. With an annual budget of $4 million, NCHCT published three broad assessments of high-priority technologies and made about 75 coverage recommendations to Medicare.
4. Congress disbanded NCHCT in 1981. The medical profession opposed it from the beginning. The AMA testified before Congress in 1981 that “clinical policy analysis and judgments are better made—and are being responsibly made—within the medical profession. Assessing risks and costs, as well as benefits, has been central to the exercise of good medical judgment for decades.”
5. The medical device lobby also opposed government oversight by NCHCT.

Examples of Lack of Proper Management of HealthCare

Treatments for Coronary Artery Disease

1. Since the early 1970s, the number of coronary artery bypass surgeries (CABGS) has risen rapidly without government regulation or clinical trials.
2. Angioplasty for single vessel disease was introduced in 1978. The first published trial of angioplasty versus medical treatment was done in 1992.
3. Angioplasty did not reduce the number of CABGS, as was promoted.
4. Both procedures increase in number every year as the patient population grows older and sicker.
5. Rates of use are higher in white patients and private insurance patients, and vary greatly by geographic region, suggesting that use of these procedures is based on non-clinical factors.
6. As of 1995, the NIH consensus program had not assessed CABGS since 1980 and had never assessed angioplasty.
7. RAND researchers evaluated CABGS in New York in 1990. They reviewed 1,300 procedures and found 2% were inappropriate, 90% were appropriate, and 7% were uncertain. For 1,300 angioplasties, 4% were inappropriate and 38% uncertain. Using RAND methodologies, a panel of British physicians rated twice as many procedures “inappropriate” as did a US panel rating the same clinical cases. The New York numbers are in question because New York State limits the number of surgery centers, and the per-capita supply of cardiac surgeons in New York is about one-half of the national average.
8. The estimated five-year cost is $33,000 for angioplasty and $40,000 for CABGS. Angioplasty did not lower costs, due to its high failure rates.

Computed Tomography (CT)

1. The first CT scanner in the US was installed at the Mayo Clinic in 1973. By 1992, the number of operational CT scanners in the US had grown to 6,060. By comparison, in 1993 there were 216 CT units in Canada .
2. There is little information available on how CT scans improve or affect patient outcomes
3. In some institutions, up to 90% of scans performed were negative.
4. Approval by the FDA was not required for CT scanners, nor was any evidence of safety or efficacy.

Magnetic Resonance Imaging (MRI)

1. MRIs were introduced in Great Britain in 1978 and in the US in 1980. By 1988, there were 1,230 units and by 1992 between 2,800 and 3,000.
2. A definitive review published in 1994 found less than 30 studies of 5,000 that were prospective comparisons of diagnostic accuracy or therapeutic choice.
3. The American College of Physicians assessed MRI studies and rated 13 of 17 trials as “weak,” i.e., lacking data concerning therapeutic impact or patient outcomes.
4. The OTA concluded: “It is evident that hospitals, physician-entrepreneurs, and medical device manufacturers have approached MRI and CT as commodities with high-profit potential, and decision-making on the acquisition and use of these procedures has been highly influenced by this approach. Clinical evaluation, appropriate patient selection, and matching supply to legitimate demand might be viewed as secondary forces.”

Laparoscopic Surgery

1. Laparoscopic cholecystectomy was introduced at a professional surgical society meeting in late 1989. By 1992, 85% of all cholecystectomies were performed laparoscopically.
2. There was an associated increase of 30% in the number of cholecystectomies performed.
3. Because of the increased volume of gall bladder operations, their total cost increased 11.4% between 1988 and 1992, despite a 25.1% drop in the average cost per surgery.
4. The mortality rate for gall bladder surgeries did not decline as a result of the lower risk because so many more were performed.
5. When studies were finally done on completed cases, the results showed that laparoscopic cholecystectomy was associated with reduced inpatient duration, decreased pain, and a shorter period of restricted activity. But rates of bile duct and major vessel injury increased and it was suggested that these rates were worse for people with acute cholecystitis. No clinical trials had been done to clarify this issue.
6. Patient demand, fueled by substantial media attention, was a major force in promoting rapid adoption of these procedures.
7. The major manufacturer of laparoscopic equipment produced the video that introduced the procedure in 1989.
8. Doctors were given two-day training seminars before performing the surgery on patients.

Infant Mortality

1. In 1990, the US ranked 24th in infant mortality of 38 developed countries with a rate of 9.2 deaths per 1,000 live births.
2. US black infant mortality is 18.6 per 1,000 live births, compared to 8.8 for whites.

Screening for Breast Cancer

1. Mammography screening in women under 50 has always been a subject of debate.
2. In 1992, the Canadian National Breast Cancer Study of 50,000 women showed that mammography had no effect on mortality for women aged 40-50.
3. The National Cancer Institute (NCI) refused to change its recommendations on mammography.
4. The American Cancer Society decided to wait for more studies on mammography.
5. In December 1993, NCI announced that women over 50 should have routine screenings every one to two years but that younger women would derive no benefit from mammography.

Summary

1. The OTA concluded: “There are no mechanisms in place to limit dissemination of technologies regardless of their clinical value.”
   Shortly after the release of this report, the OTA was disbanded.

References

1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA . 1998 Apr 15;279(15):1200-5.
2. Rabin R. Caution about overuse of antibiotics. Newsday . September 18, 2003 .
   2a. Centers for Disease Control and Prevention. CDC antimicrobial resistance and antibiotic resistance—general information. Available at: http://www.cdc.gov/drugresistance/community/. Accessed December 13, 2003 .
3. For calculations detail, see “Unnecessary Surgery.” Sources: HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm . Accessed December 18, 2003 . US Congressional House Subcommittee Oversight Investigation. Cost and Quality of Health Care: Unnecessary Surgery . Washington , DC : Government Printing Office;1976. Cited in: McClelland GB, Foundation for Chiropractic Education and Research. Testimony to the Department of Veterans Affairs' Chiropractic Advisory Committee. March 25, 2003 .
4. For calculations detail, see “Unnecessary Hospitalization.” Sources: HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm . Accessed December 18, 2003 . Siu AL, Sonnenberg FA, Manning WG, et al. Inappropriate use of hospitals in a randomized trial of health insurance plans. N Engl J Med . 1986 Nov 13;315(20):1259-66. Siu AL, Manning WG, Benjamin B. Patient, provider and hospital characteristics associated with inappropriate hospitalization. Am J Public Health . 1990 Oct;80(10):1253-6. Eriksen BO, Kristiansen IS, Nord E, et al. The cost of inappropriate admissions: a study of health benefits and resource utilization in a department of internal medicine. J Intern Med . 1999 Oct;246(4):379-87.
5. U.S. National Center for Health Statistics. National Vital Statistics Report, vol. 51, no. 5, March 14, 2003 .
6. Thomas, EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care. 2000 Mar;38(3):261-71. Thomas, EJ, Studdert DM, Newhouse JP, et al. Costs of medical injuries in Utah and Colorado . Inquiry . 1999 Fall;36(3):255-64. [Two references.]
7. Xakellis GC, Frantz R, Lewis A. Cost of pressure ulcer prevention in long-term care. Am Geriatr Soc . 1995 May;43(5):496-501.
8. Barczak CA, Barnett RI, Childs EJ, Bosley LM. Fourth national pressure ulcer prevalence survey. Adv Wound Care . 1997 Jul-Aug;10(4):18-26.
9. Weinstein RA. Nosocomial Infection Update. Emerg Infect Dis . 1998 Jul-Sep;4(3):416-20.
10. Fourth Decennial International Conference on Nosocomial and Healthcare-Associated Infections. Morbidity and Mortality Weekly Report. February 25, 2000 , Vol. 49, No. 7, p.138.
11. Burger SG, Kayser-Jones J, Bell JP. Malnutrition and dehydration in nursing homes: key issues in prevention and treatment. National Citizens' Coalition for Nursing Home Reform. June 2000. Available at: http://www.cmwf.org/programs/elders/burger_mal_386.asp. Accessed December 13, 2003 .
12. Starfield B. Is US health really the best in the world? JAMA . 2000 Jul 26;284(4):483-5. Starfield B. Deficiencies in US medical care. JAMA . 2000 Nov 1;284(17):2184-5.
13. HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm . Accessed December 18, 2003 .
14. Nationwide poll on patient safety: 100 million Americans see medical mistakes directly touching them [press release]. McLean , VA : National Patient Safety Foundation; October 9, 1997 .
15. The Society of Actuaries Health Benefit Systems Practice Advancement Committee. The Troubled Healthcare System in the US . September 13, 2003 . Available at: http://www.soa.org/sections/troubled_healthcare.pdf. Accessed December 18, 2003 .
16. Leape LL. Error in medicine. JAMA . 1994 Dec 21;272(23):1851-7.
17. a.Brennan TA, Leape LL, Laird NM , et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med . 1991 Feb 7;324(6):370-6.
18. Campbell EG, Weissman JS, Clarridge B, Yucel R, Causino N, Blumenthal D. Characteristics of medical school faculty members serving on institutional review boards: results of a national survey. Acad Med . 2003 Aug;78(8):831-6.
19. Possible conflict of interest within medical profession. HealthDayNews. August 15, 2003 .
20. World Health Organization. Press Release Bulletin #9. December 17, 2001 .
21. Angell M. Is academic medicine for sale? N Engl J Med . 2000 May 18;342(20):1516-8.
22. McKenzie J. Conflict of interest? Medical journal changes policy of finding independent doctors [transcript]. ABC News. June 12, 2002 .
23. Crossen C. Tainted Truth: The Manipulation of Fact in America . New York , NY : Simon & Schuster; 1994.
24. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA . 1995 Jul 5;274(1):29-34.
25. Vincent C, Stanhope N, Crowley-Murphy M. Reasons for not reporting adverse incidents: an empirical study. J Eval Clin Pract . 1999 Feb;5(1):13-21.
26. Wald H, Shojania KG. Incident reporting. In: Shojania KG, Duncan BW, McDonald KM, et al, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices . Rockville , MD : Agency for Healthcare Research and Quality; 2001:chap 4. Evidence Report/Technology Assessment No. 43. AHRQ publication 01-E058.
27. Grinfeld MJ. The debate over medical error reporting. Psychiatric Times . April 2000.
28. King G III, Hermodson A. Peer reporting of coworker wrongdoing: A qualitative analysis of observer attitudes in the decision to report versus not report unethical behavior. Journal of Applied Communication Research . 2000;(28), 309-29.
29. Gilman AG, Rall TW, Nies AS , Taylor P. Goodman and Gilman's The Pharmacological Basis of Therapeutics. New York , NY : Pergamon Press; 1996.
30. Kolata G. New York Times News Service. Who cares when our drugs fail? San Diego Union-Tribune . October 15, 1997 :E-1,5.
31. Melmon KL, Morrelli HF, Hoffman BB, Nierenberg DW, eds. Melmon and Morrelli's Clinical Pharmacology: Basic Principles in Therapeutics . 3rd ed. New York , NY : McGraw-Hill, Inc., 1992.
32. Moore TJ, Psaty BM, Furberg CD. Time to act on drug safety . JAMA . 1998 May 20, 279 (19):1571-3.
    32 a.Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR , Leape LL. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv . 1995 Oct;21(10):541-8.
33. Bates DW. Drugs and adverse drug reactions: how worried should we be? JAMA . 1998 Apr 15;279(15):1216-7.
34. Dickinson, JG. FDA seeks to double effort on confusing drug names. Dickinson 's FDA Review . 2000 Mar;7(3):13-4.
35. Cohen JS. Overdose: The Case Against the Drug Companies . New York , NY : Tarcher-Putnum; 2001.
36. Stenson J. Few residents report medical errors, survey finds. Reuters Health. February 21, 2003 .
37. Survey by Henry J. Kaiser Family Foundation, Harvard School of Public Health. Methodology: Fieldwork conducted by ICR - International Communications Research, April 11- June 11, 2002
38. Bond CA, Raehl CL, Franke T. Clinical pharmacy services, hospital pharmacy staffing, and medication errors in United States hospitals. Pharmacotherapy . 2002 Feb;22(2):134-47.
39. Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL. Medication errors observed in 36 health care facilities. Arch Intern Med . 2002 Sep 9;162(16):1897-903.
40. LaPointe NM , Jollis JG. Medication errors in hospitalized cardiovascular patients. Arch Intern Med . 2003 Jun 23;163(12):1461-6.
41. Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med . 2003 Feb 4;138(3):161-7.
42. Gandhi TK, Weingart SN, Borus J, et al. Adverse drug events in ambulatory care. N Engl J Med . 2003 Apr 17;348(16):1556-64.
43. Medication side effects strike 1 in 4. Reuters. April 17, 2003 .
44. Vastag B. Pay attention: ritalin acts much like cocaine. JAMA . 2001 Aug 22-29;286(8):905-6.
45. Rosenthal MB, Berndt ER, Donohue JM, Frank RG, Epstein AM. Promotion of prescription drugs to consumers. N Engl J Med . 2002 Feb 14;346(7):498-505.
46. Wolfe SM. Direct-to-consumer advertising—education or emotion promotion? N Engl J Med . 2002 Feb 14;346(7):524-6.
47. Ibid.
48. US General Accounting Office. Report to the Chairman, Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Operations, House of Representatives: FDA Drug Review Postapproval Risks 1976-85 . Washington , DC : US General Accounting Office; 1990:3.
49. Drug giant accused of false claims. MSNBC News. July 11, 2003 . Available at: http://msnbc.com/news/937302.asp?0sl=-42&cp1=1. Accessed December 17,2003 .
50. Suh DC , Woodall BS, Shin SK , Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother . 2000 Dec;34(12):1373-9.
51. Agger WA. Antibiotic resistance: unnatural selection in the office and on the farm. Wisconsin Medical Journal . August 2002.
52. Nash DR, Harman J, Wald ER, Kelleher KJ. Antibiotic prescribing by primary care physicians for children with upper respiratory tract infections. Arch Pediatr Adolesc Med . 2002 Nov;156(11):1114-9.
53. Schindler C, Krappweis J, Morgenstern I, Kirch W. Prescriptions of systemic antibiotics for children in Germany aged between 0 and 6 years. Pharmacoepidemiol Drug Saf . 2003 Mar;12(2):113-20.
54. Finkelstein JA, Stille C, Nordin J, et al. Reduction in antibiotic use among US children, 1996-2000. Pediatrics . 2003 Sep;112(3 Pt 1):620-7.
55. Linder JA, Stafford RS. Antibiotic treatment of adults with sore throat by community primary care physicians: a national survey, 1989-1999. JAMA . 2001 Sep 12;286(10):1181-6.
56. Drug resistance page. Centers for Disease Control and Prevention website. Available at: http://www.cdc.gov/drugresistance/community/. Accessed December 17, 2003 .
57. Available at: http://www.health.state.ok.us/program/cdd/ar/. Accessed December 17, 2003 .
58. Available at: http://www.librainitiative.com/life/en/libra_initiative.html. Accessed December 17, 2003 .
59. Ohlsen K, Ternes T, Werner G, et al. Impact of antibiotics on conjugational resistance gene transfer in Staphylococcus aureus in sewage. Environ Microbiol . 2003 Aug;5(8):711-6.
60. Pawlowski S, Ternes T, Bonerz M, et al. Combined in situ and in vitro assessment of the estrogenic activity of sewage and surface water samples. Toxicol Sci . 2003 Sep;75(1):57-65. Epub 2003 Jun 12.
61. Ternes TA, Stuber J, Herrmann N, et al. Ozonation: a tool for removal of pharmaceuticals, contrast media and musk fragrances from wastewater? Water Res . 2003 Apr;37(8):1976-82.
62. Ternes TA, Meisenheimer M, McDowell D, et al. Removal of pharmaceuticals during drinking water treatment. Environ Sci Technol . 2002 Sep 1;36(17):3855-63.
63. Ternes T, Bonerz M, Schmidt T. Determination of neutral pharmaceuticals in wastewater and rivers by liquid chromatography-electrospray tandem mass spectrometry. J Chromatogr A . 2001 Dec 14;938(1-2):175-85.
64. Golet EM, Alder AC, Hartmann A, Ternes TA, Giger W. Trace determination of fluoroquinolone antibacterial agents in urban wastewater by solid-phase extraction and liquid chromatography with fluorescence detection. Anal Chem . 2001 Aug 1;73(15):3632-8.
65. Daughton CG, Ternes TA. Pharmaceuticals and personal care products in the environment: agents of subtle change? Environ Health Perspect . 1999 Dec;107 Suppl 6:907-38.
66. Hirsch R, Ternes T, Haberer K, Kratz KL. Occurrence of antibiotics in the aquatic environment. Sci Total Environ . 1999 Jan 12;225(1-2):109-18.
67. Ternes TA, Stumpf M, Mueller J, Haberer K, Wilken RD , Servos M. Behavior and occurrence of estrogens in municipal sewage treatment plants—I. Investigations in Germany , Canada and Brazil . Sci Total Environ . 1999 Jan 12;225(1-2):81-90.
68. Hirsch R, Ternes TA, Haberer K, Mehlich A, Ballwanz F, Kratz KL. Determination of antibiotics in different water compartments via liquid chromatography-electrospray tandem mass spectrometry. J Chromatogr A . 1998 Jul 31;815(2):213-23.
69. Coste J, Hanotin C, Leutenegger E. Prescription of non-steroidal anti-inflammatory agents and risk of iatrogenic adverse effects: a survey of 1072 French general practitioners. Therapie . 1995 May-Jun;50(3):265-70.
70. Kouyanou K, Pither CE, Wessely S. Iatrogenic factors and chronic pain. Psychosom Med . 1997 Nov-Dec;59(6):597-604.
71. Abel U. Chemotherapy of advanced epithelial cancer—a critical review. Biomed Pharmacother . 1992;46(10):439-52.
72. Schulman KA, Stadtmauer EA, Reed SD , et al. Economic analysis of conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. Bone Marrow Transplant . 2003 Feb;31(3):205-10.
73. Kaufman, M. Drugmaker to pay FDA $500 million. Manufacturing problems found at schering-plough . The Washington Post . May 18, 2002 :A01.
74. US Congressional House Subcommittee Oversight Investigation. Cost and Quality of Health Care: Unnecessary Surgery . Washington , DC : Government Printing Office;1976. Cited in: McClelland GB, Foundation for Chiropractic Education and Research. Testimony to the Department of Veterans Affairs' Chiropractic Advisory Committee. March 25, 2003 .
75. Leape LL. Unnecessary surgery. Health Serv Res . 1989 Aug;24(3):351-407.
76. McClelland GB, Foundation for Chiropractic Education and Research. Testimony to the Department of Veterans Affairs' Chiropractic Advisory Committee. March 25, 2003 .
77. Coile RC Jr. Internet-driven surgery. Russ Coiles Health Trends . 2003 Jun;15(8):2-4.
78. Guarner V. Unnecessary operations in the exercise of surgery. A topic of our times with serious implications in medical ethics. Gac Med Mex . 2000 Mar-Apr;136(2):183-8.
79. Rutkow IM. Surgical operations in the United States : 1979 to 1984. Surgery . 1987 Feb;101(2):192-200.
80. Rutkow IM. Surgical operations in the United States . Then (1983) and now (1994). Arch Surg . 1997 Sep;132(9):983-90.
81. Linnemann MU, Bulow HH. Infections after insertion of epidural catheters. Ugeskr Laeger . 1993 Jul 26;155(30):2350-2
82. Seres JL, Newman RI . Perspectives on surgical indications. Implications for controls. Clin J Pain . 1989 Jun;5(2):131-6.
83. Chassin MR, Kosecoff J, Park RE, et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA. 1987 Nov 13;258(18):2533-7.
84. Office of Technology Assessment, US Congress. Assessing the Efficacy and Safety of Medical Technologies. Washington DC : Office of Technology Assessment, US Congress; 1978.
85. Tunis SR, Gelband H. Health care technology in the United States . Health Policy . 1994 Oct-Dec;30(1-3):335-96.
86. Zhan C, Miller M. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA . 2003;290:1868-1874.
87. Injuries in hospitals pose a significant threat to patients and a substantial increase in health care charges [press release]. Rockville , MD : Agency for Healthcare Research and Quality. October 7, 2003 . http://www.ahrq.gov/news/ress/pr2003/injurypr.htm.
88. Weingart SN, Iezzoni LI. Looking for medical injuries where the light is bright. JAMA . 2003 Oct 8 ;290(14):1917-9.
89. MacMahon B. Prenatal x-ray exposure and childhood cancer. J Natl Cancer Inst . 1962 May;28:1173-91.
90. Health Physics Society. Available at: http://hps.org/publicinformation/ate/q1084.html. Accessed December 17, 2003 .
91. Gofman JW. Radiation from Medical Procedures in the Pathogenesis of Cancer and Ischemic Heart Disease: Dose-Response Studies with Physicians per 100,000 Population. San Francisco , CA : CNR Books; 1999.
92. Gofman J W. Preventing Breast Cancer: The Story of a Major, Proven, Preventable Cause of This Disease . 2nd ed. San Francisco , CA : CNR Books; 1996.
93. Sarno JE. Healing Back Pain: The Mind-Body Connection . Warner Books; 1991.
94. Siu AL, Sonnenberg FA, Manning WG, et al. Inappropriate use of hospitals in a randomized trial of health insurance plans. N Engl J Med . 1986 Nov 13;315(20):1259-66.
95. Siu AL, Manning WG, Benjamin B. Patient, provider and hospital characteristics associated with inappropriate hospitalization. Am J Public Health . 1990 Oct;80(10):1253-6.
96. Eriksen BO, Kristiansen IS, Nord E, et al. The cost of inappropriate admissions: a study of health benefits and resource utilization in a department of internal medicine. J Intern Med . 1999 Oct;246(4):379-87.
97. Showalter E. Hystories: Hysterical Epidemics and Modern Media . New York , NY : Columbia University Press; 1997.
98. Fugh-Berman A. Alternative healing. In: Smith B, Steinem G, Mink G, Navarro M, and Mankiller W, eds. The Reader's Companion to U.S. Women's History. New York , NY : Houghton Mifflin; 1998. Available at: http://college.hmco.com/history/readerscomp/women/html/wh_001200_alternativeh.htm .
99. Thacker SB, Stroup D, Chang M. Continuous electronic heart rate monitoring for fetal assessment during labor (Cochrane Review). In: The Cochrane Library, issue 1, 2003. Oxford : Update Software.
100. Cole C. Admission electronic fetal monitoring does not improve neonatal outcomes . J Fam Pract . 2003 Jun;52(6):443-4.
101. Nelson HD, Humphrey LI, Nygren P, Teutsch SM, Allan JD. Postmenopausal hormone replacement therapy: scientific review. JAMA . 2002 Aug 21;288(7):872–81.
102. Nelson HD. Assessing benefits and harms of hormone replacement therapy: clinical applications. JAMA . 2002 Aug 21;288(7):882-4
103. Fletcher SW, Colditz GA. Failure of estrogen plus progestin therapy for prevention. JAMA . 2002 Jul 17;288(3):366-8.
104. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA . 2002 Jul 17;288(3):321-33.
105. Rutkow IM. Obstetric and gynecologic operations in the United States , 1979 to 1984. Obstet Gynecol . 1986 Jun;67(6):755-9.
106. Family Practice News . February 15, 1995 : 29.
107. Sakala C. Medically unnecessary cesarean section births: introduction to a symposium. Soc Sci Med . 1993 Nov;37(10):1177-98.
108. VanHam MA, van Dongen PW, Mulder J. Maternal consequences of cesarean section. A retrospective study of intra-operative and postoperative maternal complications of cesarean section during a 10-year period. Eur J Obstet Reprod Biol . 1997 Jul;74(1):1-6.
109. Weiner J. Smoking and cancer: the cigarette papers: how the industry is trying to smoke us all . The Nation . January 1, 1996 :11-18.
110. Tobacco.org. Tobacco timeline. Available at: http://www.tobacco.org/resources/history/tobacco_history.html. Acccessed December 16, 2003 .
111. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. 2002. Timing of new black box warnings and withdrawals for prescription medications. JAMA . 2002 May 1;287(17):2215-20.
112. Injuryboard.com. General Accounting Office study sheds light on nursing home abuse. July 17, 2003 . Available at: http://www.injuryboard.com/view.cfm/Article=3005. Accessed December 17, 2003 .
113. Weingart SN, McL Wilson R, Gibberd RW, Harrison B. Epidemiology of medical error. West J Med . 2000 Jun;172(6):390-3.
114. Blendon R, Schoen C, et al. Five nation survey exposes flaws in the U.S. health care system. Health Affairs . May/June 2002.
115. Institute of Medicine . Care Without Coverage: Too Little, Too Late . May 21, 2002 . A Shared Destiny: Community Effects of Uninsurance . March 6, 2003 .
116. US Department of Health and Human Services and US Department of Justice. Health Care Fraud and Abuse Control Program Annual Report for FY 1998. April 1999. Health Care Fraud and Abuse Control Program Annual Report for FY 2001. April 2002.
117. Abuse of residents is a major problem in U.S. nursing homes [transcript]. CNN television. July 30, 2001
     117 a. Available at: http://www.house.gov/waxman. Accessed December 17, 2003 .
118. Mitka M. Unacceptable nursing home deaths unautopsied. JAMA . 1998 Sep 23-30;280(12):1038-9
119. New data is in on North Carolina 's nursing home residents. Medical Review of North Carolina, Inc. July 21, 2003 .
120. Weinstein RA. Nosocomial infection update. Emerg Infect Dis . 1998 Jul-Sep;4(3):416-20.
121. Centers for Medicare & Medicaid Services. Report to Congress: Appropriateness of Minimum Nurse Staffing Ratios In Nursing Homes: Phase II Final Report . December 24, 2001 .
122. Consumer group criticizes Thompson letter dismissing report on dangerous staffing levels in nursing homes [news release]. Washington , DC : National Citizens' Coalition for Nursing Home Reform. March 22, 2002 .
123. Bergstrom N, Braden B, Kemp M, Champagne M, Ruby E. Multi-site study of incidence of pressure ulcers and the relationship between risk level, demographic characteristics, diagnoses and prescription of preventive interventions . J Am Geriatr Soc . 1996 Jan;44(1):22-30.
124. Miles SH. Concealing accidental nursing home deaths. HEC Forum . 2002 Sep;14(3):224-34.
125. Corey TS, Weakley-Jones B, Nichols GR 2nd, Theuer HH. Unnatural deaths in nursing home patients. J Forensic Sci . 1992 Jan;37(1):222-7.
126. Lloyd-Jones DM, Martin DO, Larson MG, Levy D. Accuracy of death certificates for coding coronary heart disease as the cause of death. Ann Intern Med . 1998 Dec 15;129(12):1020-6.
127. Thomas DR , Zdrowski CD, Wilson MM, et al. Malnutrition in subacute care. Am J Clin Nutr . 2002 Feb;75(2):308-13.
128. Robinson BE. Death by destruction of will. Lest we forget. Arch Intern Med . 1995 Nov 13;155(20):2250-1.
129. Capezuti E, Strumpf NE, Evans LK, Grisso JA, Maislin G. The relationship between physical restraint removal and falls and injuries among nursing home residents . J Gerontol A Biol Sci Med Sci . 1998 Jan;53(1):M47-52.
130. Phillips CD, Hawes C, Fries BE. Reducing the use of physical restraints in nursing homes: will it increase costs? Am J Public Health . 1993 Mar;83(3):342-8.
131. Miles SH, Irvine P. Deaths caused by physical restraints. Gerontologist . 1992 Dec;32(6):762-6.
132. Annas GJ. The last resort—the use of physical restraints in medical emergencies. N Engl J Med . 1999 Oct 28;341(18):1408-12.
133. Parker K, Miles SH. Deaths caused by bedrails. J Am Geriatr Soc . 1997 Jul;45(7):797-802.
134. Miles SH. Concealing accidental nursing home deaths. HEC Forum . 2002 Sep;14(3):224-34.
135. Katz PR, Seidel G. Nursing home autopsies. Survey of physician attitudes and practice patterns. Arch Pathol Lab Med . 1990 Feb;114(2):145-7.
136. Overmedication of U.S. seniors. Reuters Health. May 21, 2003 .
137. Average number of prescriptions by HMOs increases. Drug Benefit Trends . 2002 Sep 12;14(8).
138. Kaiser Family Foundation. Prescription Drug Trends . November 2001.
139. Williams BR, Nichol MB, Lowe B, Yoon PS, McCombs JS, Margolies J. Medication use in residential care facilities for the elderly. Ann Pharmacother . 1999 Feb;33(2):149-55.
140. AARP. Medicare and prescription drugs. Available at: http://www.aarp.org/prescriptiondrugs. Accessed December 16, 2003 .
141. California reaches $100 million multi-state settlement with drug giant Mylan over alleged price-fixing scheme [press release]. Sacramento , CA : Office of the Attorney General, Department of Justice, State of California ; July 12, 2000 .
142. Attorney general reaches settlement with drug giant. WRAL News. March 7, 2003 . Available at: . http://www.wral.com/money/2026364/detail.html . Accessed December 16, 2003 .
143. Blowing the final whistle. The Observer. November 25, 2001 . Available at: http://education.guardian.co.uk/businessofresearch/comment/0,9976,606260,00.html. Accessed December 16, 2003 .
144. AARP. Are food supplements for me. Available at: http://www.aarp.org/Articles/a2003-03-07-supplements.html. Accessed December 16,2003 .
145. Bernabei R, Gambassi G, Lapane K, et al. Management of pain in elderly patients with cancer. SAGE study group. Systematic assessment of geriatric drug use via epidemiology. JAMA . 1998 Jun 17;279(23):1877-82.
146. Associated Press. Panel names estrogen as carcinogen. The Washington Post . December 16, 2000 :A05.
147. Estrogen hikes ovarian cancer risk. MSNBC staff and wire reports. July 16, 2002 . Grady D. Study recommends NOT using hormone therapy for bone loss. New York Times . October 1, 2003 .
148. Anderson GL, Judd HL, Kaunitz AM, et al. Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized trial. JAMA . 2003 Oct 1;290(13):1739-48.
149. Chlebowski RT, Hendrix SL, Langer RD , et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative randomized trial. JAMA . 2003 Jun 25;289(24):3243-53.
150. Wassertheil-Smoller S, Hendrix SL, Limacher M, et al . Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA . 2003 May 28;289(20):2673-84.
151. Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative memory study: a randomized controlled trial. JAMA 2003;289:2651-62 .
152. Beral V; Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet . 2003 Aug 9;362(9382):419-27.

--
NYRKKISÄÄNTÖ: kun luet lehtiä, virallisia tiedoitteita tai kuuntelet uutisia, muista että jokainen sana tarkoittaa sen ilmimerkitykseen nähden täsmälleen päinvastaista asiaa (Nevanlinna ja Relander: Työn sanat).