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Artikel

Pendidikan dan Proses Humanisasi

Tanggal : 16/08/2009, dibaca 2968 kali.

Manusia adalah sebagai makhluk sosial ( Homo Sosius ), yang dibekali Tuhan dengan akal, di mana akal akan menjadikan manusia mengetahui segala sesuatu. Sesuatu yang sepele terkadang terlupakan begitu saja dalam kehidupan. Manusia sering terfokus kepada persoalan besar, namun sering kali terlena pada permasalahan yang sepele.

Padahal bila ditinjau secara filosofis, akan menjadi fondasi untuk membangun kesadaran intelektual. Maka dari itu manusia seharusnya memahami hakekat diri dan lingkungan dalam proses perubahan. Proses penyadaran di sini menjadi amat penting di dalam kehidupan manusia.

Pendidikan merupakan proses yang dilakukan oleh sebagian masyarakat di belahan dunia manapun. Namun pendidikan yang diharapkan sebagai bagian dari proses kehidupan yang dapat mengentaskan manusia dari penindasan dan kesengsaraan ternyata menjadi bagian yang menindas manusia itu sendiri.

Oleh karena itu bagaimana sekarang memposisikan proses pembelajaran sebagai hal yang suci dan sesuai dengan harapan masyarakat, yaitu sebuah proses pembelajaran yang tidak menindas dan tidak ada yang tertindas. Ketika seseorang merasakan hak-haknya dirampas, maka seharusnya ia menuntut.

Pada dasarnya tidak ada yang dapat mengubah nasib kita kecuali diri kita sendiri. Oleh karena itu, setiap manusia harus berusaha keluar dari segala bentuk penindasan dan berusaha memerangi setiap bentuk penindasan. Selama ini kita melihat penindasan justru lahir dari dunia pendidikan yang selama ini kita banggakan.

Sekolah selama ini dijadikan sebuah pabrik, di mana lulusan-lulusannya siap menjadi tenaga kerja siap pakai. Maka sebagian fungsi sekolah yang ada di Indonesia tidak lebih hanya sebagai cara untuk mencari bekal untuk kerja. Tidak mengherankan ketika siswa tidak menjadi semakin cerdas, tapi menjadi semakin beringas dan brutal.

Tawuran pelajar terjadi dimana-mana dan banyak sekali penyalahgunaan NARKOBA yang dilakukan oleh pelajar. Hal itu merupakan bukti ketidakberhasilan sekolah untuk membentuk siswa menjadi manusia pembelajar. Pembelajar adalah individu-individu yang dapat memilah dan memilih mana yang baik dan yang buruk.

Beberapa contoh di atas merupakan pertanda bahwa pendidikan hanya dijadikan ajang penindasan bagi siswa. Erat kaitannya dengan hal tersebut, Freire yang adalah seorang tokoh pendidikan menggagas adanya concientizacao ( kesadaran untuk melakukan ). Concientizacao adalah kesadaran untuk melakukan pembelaan kemanusiaan. Dapat memberantas buta huruf di kalangan orang dewasa misalnya, dimaknai sebagai usaha membebaskan manusia dari belenggu kebodohan.

Freire mengklarifikasikan kesadaran dalam tiga hal. Pertama, kesadaran magis ( magical conciousness ) yaitu kesadaran yang tidak mampu melihat kaitan antara satu faktor dengan yang lainnya, dalam hal ini melihat faktor di luar manusia. Kedua, kesadaran naf ( Naival consciousness ) yaitu manusia menjadi akar penyebab masalah masyarakat. Ketiga, kesadaran kritis ( critical conciousness ) yaitu sistem dan struktur sebagai sumber masalah. Kritis penyadaran struktur dan sistem politik, sosial, ekonomi, budaya pada masyarakat. Hal ini menunjukan bahwa kritisme sangatlah penting di dalam pelembagaan penyadaran masyarakat.

Sebuah kenyataan tidak harus menjadi suatu keharusan. Jika kenyataan menyimpang dari keharusan, maka tugas manusia untuk merubahnya, agar sesuai dengan apa yang seharusnya. Kenyataan tersebut sering disebut dengan fitrah. Fitrah manusia sejati adalah pelaku ( subyek ), bukan obyek atau penderita. Fitrah manusia adalah menjadi merdeka dan menjadi bebas. Kesemuanya itu sering disebut dengan tujuan humanisasi Freire.

Freire juga menyebutkan pendidikan seharusnya berorientasi kepada pengenalan realitas dari manusia dan dirinya. Hal itu berarti bahwa pendidikan bukan hanya sebagai ajang transfer of knowledge akan tetapi bagaimana ilmu pengetahuan dijadikan sarana untuk mendidik manusia agar mampu membaca realitas sosial. Hal ini juga didukung oleh Lodge yang menyatakan life is education, education is life.

*) Penulis adalah Benny Setiawan, mahasiswa fakultas Syari'ah Universitas Islam Negeri (UIN) Sunan Kalijaga, Yogyakarta.



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However, a well-circulated grievance pointed to one unanticipated consequence of the amendments: the new burden of proof appeared to make the process of drug development both more expensive and much longer, leading to increasing drug prices and a �drug lag� in which innovative compounds reached markets in Europe long before they reached the U.S. market. Industry agitation surrounding the �drug lag� finally led to modification of the drug patenting system in the Drug Price Competition and Patent Term Restoration Act of 1984 � through further extension of drug patents. Indirectly, then, Kefauver's amendments ultimately affected both pharmaceutical pricing and patenting � in a manner diametrically opposed to the one he intended.
If the corporate fines are too small, the False Claims Act will need to be amended so that a higher percentage of the revenues derived from fraudulent activities is recouped. At the same time, federal law must insist on greater transparency for clinical trial results, so that negative safety data are not hidden from clinicians and regulators.
Clinicians must consider the arrhythmogenic potential not only of azithromycin but also of potential alternative antibacterial drugs. An earlier study showed an association between the use of erythromycin and sudden cardiac death, augmented by concomitant use of inhibitors of the cytochrome P-450 3A isozymes that metabolize erythromycin.4 Labels for erythromycin and clarithromycin include warnings regarding QT-interval prolongation and arrhythmias. All labels for fluoroquinolone products similarly have warnings regarding QT-interval prolongation, and grepafloxacin was withdrawn from the market because of that risk. A recent observational study of elderly residents of Quebec, Canada, showed an association between outpatient fluoroquinolone use and serious arrhythmias (as defined by hospital discharge diagnoses of ventricular arrhythmia or sudden or unattended death).5 And although Ray et al. found the risk of cardiovascular death to be greater with azithromycin than with ciprofloxacin, they found the risk with levofloxacin similar to that with azithromycin. The authors interpreted this similarity as evidence that levofloxacin may be proarrhythmic; however, levofloxacin was not implicated as proarrhythmic in the Canadian study.
Despite such caveats, the results presented by Ray et al. warrant serious attention. A chief strength of the results is the time-limited pattern of the risk: the azithromycin-associated increase in the rates of death from any cause and from cardiovascular causes spanned days 1 through 5, reflecting the typical 5-day duration of azithromycin administration (e.g., Zithromax Z-Pak). On days 6 through 10, an elevated risk of death from cardiovascular causes was no longer detected. This pattern is consistent with the timing of peak plasma azithromycin concentrations and the concomitant risk of QT-interval prolongation. The elevated risk was statistically significant, regardless of whether azithromycin treatment was compared with amoxicillin or with nonuse of an antibacterial drug. Furthermore, the observed excess mortality was attributable solely to cardiovascular deaths and, in particular, to sudden cardiac death; although sudden cardiac death can result from causes other than arrhythmias, an increase in deaths in this category would be the pattern expected from an arrhythmogenic, QT-interval�prolonging drug. Also, the azithromycin-associated risk was higher among patients with cardiovascular disorders, which is consistent with a drug-related arrhythmia.
To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.
The amendments granted the FDA the power to demand proof of efficacy � in the form of �adequate and well-controlled investigations� � before approving a new drug for the U.S. market. They also led to a retrospective review of all drugs approved between 1938 and 1962 (the Drug Efficacy Study Implementation program), which by the early 1970s had categorized approximately 600 medicines as �ineffective� and forced their removal from the market. These market-making and unmaking powers were also tied to a new structure of knowledge generation: the orderly sequence of phase 1, phase 2, and phase 3 trials now seen as a natural part of any pharmaceutical life cycle.
The Food and Drug Administration (FDA) has completed a head-to-head bioequivalence study of single doses of the generic drug Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) and the brand-name drug Wellbutrin XL 300 mg (Biovail). The agency has concluded that Budeprion XL 300 mg cannot be considered therapeutically equivalent to the brand-name product. We at the FDA are therefore changing our bioequivalence recommendations for extended-release bupropion products and have asked other manufacturers of 300-mg extended-release bupropion products to conduct additional bioequivalence studies.
The federal Office for Human Research Protections (OHRP), which is charged with providing leadership in the protection of the rights, welfare, and well-being of persons involved in research conducted or supported by the U.S. Department of Health and Human Services (DHHS), asserted in March 2013, on the basis of its own examination of the evidence, that the SUPPORT researchers failed to provide prospective parents sufficient information about the risks posed by the study. After a detailed review of the protocol, the relevant consent documents, and the research literature, we respectfully disagree with the conclusions of the OHRP, which we believe resulted from a fundamental difference in interpretations of how the regulations should apply to the state of scientific understanding when the SUPPORT study commenced. Moreover, there is a larger issue here: how risks should be conveyed in the informed-consent process when research is comparing interventions that are all considered to be the standard of care.
The GSK corporate integrity agreement does include some provisions that attempt to change corporate culture. First, GSK must revise its compensation systems to �ensure that financial incentives do not inappropriately motivate� sales representatives; these changes include new restrictions on compensation for off-label promotion. GSK has now implemented a program to eliminate incentive-based compensation for sales representatives based on �territory/individual level sales goals,� which will alter the financial incentives for sales representatives who meet with physicians. Second, GSK senior executives and other employees who are paid bonuses and other compensation may in the future be asked to repay those amounts if certain types of fraudulent behavior occur that violate the corporate integrity agreement. As has been noted in the financial press, this requirement does nothing to recoup several substantial recent bonuses given to senior management at such firms,2 but it does make it more difficult to repeat the practice, at least at GSK. Third, in view of the serious questions about failure to report negative data related to Avandia's safety, GSK must commit itself to �research and publication practices� designed to make more clinical trial information available to clinicians and regulators. These commitments have several disturbing exceptions: GSK will �generally� seek publication for research results, and summaries of clinical trial data will be posted on a clinical study register �with rare exception.� These are but partial steps toward transparency.
Third, patient access should be equated with the availability of reimbursement rather than with device approval, because broad patient access to a new device doesn't occur until reimbursement by a national or third-party payer is available. Previous comparisons of the U.S. and European systems have used the approval date to measure process duration, but innovative, high-risk devices don't reach a market where most patients can benefit from them immediately after gaining regulatory approval, though they may be accessible to patients who can afford to pay out of pocket. Rather, there is a second level of review through which public or private insurers decide whether and at what price they will pay for a device. Generally, public systems take longer than private insurers to make reimbursement decisions, and significantly more Europeans than Americans have public insurance. Two thirds of the U.S. population is covered by private health insurance, whereas only a fifth receives publicly funded reimbursement, primarily administered by the Centers for Medicare and Medicaid Services (CMS).
To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see tableComparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.). These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.
Depending on patients' frailty and disability status, the desirable outcome and treatment choices might vary: different patients place different values on benefits and risks. Certain adverse events, such as dizziness leading to falls, may be of greater importance in the geriatric population. The design of a clinical trial should consider age-appropriate end points; for older people, functional outcomes may be most important, and an emphasis on such outcomes could lead to reduced costs for health care systems.
The acquisition of relevant data to elucidate the benefit�risk ratio in the target population requires more than merely balancing the absolute numbers of patients. Depending on the drug's profile and the target population, investigators will face a learning curve with regard to acquiring data and modulating risk for patients who might be more susceptible to adverse outcomes, such as frail patients or those taking multiple medications. In designing a strategic plan for drug development, it will be important to engage in a dialogue with regulators to ensure that the needs and requirements of older patients are considered. Investigation of population pharmacokinetics or a specific pharmacokinetic study including the very elderly should be performed and will help inform prescribing. Modeling and simulation can offer powerful tools for quantitatively evaluating differences in pharmacokinetics and pharmacodynamics, recommending dosing regimens, and identifying patients at risk. Some of the lessons learned from the experience in pediatric clinical trials can be applied to the older population; heterogeneity can, in some measure, be allowed and analyzed in clinical-trial design both before and after market authorization.
In a 2012 observational study involving Tennessee Medicaid patients, Ray et al.1 quantified the risk of death from cardiovascular causes associated with azithromycin as compared with other antibacterial drugs or nonuse. The study showed that the risks of death, both from any cause and from cardiovascular causes, associated with azithromycin were greater than those associated with amoxicillin. For every 21,000 outpatient prescriptions written for azithromycin, one cardiovascular death occurred in excess of those observed with the same number of amoxicillin prescriptions. The excess risk over amoxicillin varied considerably according to cardiovascular risk factors; the researchers estimated that there was one excess cardiovascular death per 4100 prescriptions among patients at high cardiovascular risk but less than one per 100,000 among patients with lower cardiovascular risk.
An important finding of the study was a reduced incidence of ROP in the lower oxygen-saturation range. However, contrary to what was known at the time, the study also showed a slightly but significantly increased incidence of death � 19.9% versus 16.2% (P=0.04) � among infants assigned to the lower as compared with the upper range. As a result, last year the AAP amended its guidelines, citing SUPPORT, and physicians treating very premature infants are starting to use higher saturation rates to reduce the risk of death, even with the potentially higher risk of ROP at these levels. Studies such as SUPPORT that compare two alternatives, both within current standard clinical practice, often lead to critical improvements in medical care.
But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies' revenue.1 Companies might well view such fines as merely a cost of doing business � a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms' past misdeeds.
On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act.
These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than in another and do not reflect experiences with all innovative, high-risk devices. However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.
The other major difference observed between Budeprion XL 300 mg and Wellbutrin XL 300 mg was in the time to peak drug concentration in the blood (Tmax) (see graph). Although FDA guidance does not include Tmax as a criterion for bioequivalence of bupropion hydrochloride products, the Tmax for Budeprion XL (4 hours) is shorter than that for Wellbutrin XL (5 hours). A similar difference in Tmax values was also observed in the bioequivalence study of the 150-mg products that was originally used for extrapolation of data for Budeprion XL 300 mg. But because the comparative area-under-the-curve and Cmax values for the 150-mg products fell within FDA parameters and were supported by data on the performance of the product in vitro, Budeprion XL 300 mg was approved.
A new study by Svanstr�¶m and colleagues (pages 1704в��1712), using Danish national health care data, found no difference between azithromycin and penicillin V in the 5-day risk of cardiovascular death (relative risk, 0.93; 95% confidence interval [CI], 0.56 to 1.55). However, the upper bound of the 95% confidence interval does not exclude an increased risk of as much as 55%. As Svanstr�¶m et al. point out, the population they studied differed from that studied by Ray et al. with respect to the baseline risk of death and cardiovascular risk factors. Overall, the Danish patients had better cardiovascular health than the Tennessee Medicaid patients. In a subgroup analysis of patients with a history of cardiovascular disease, the risk ratio for azithromycin versus penicillin V was greater than 1, though the difference was not statistically significant (relative risk, 1.35; 95% CI, 0.69 to 2.64). Svanstr�¶m et al. conclude that their results do not conflict with those of Ray et al. Rather, the effect on cardiovascular mortality may be limited to patients with cardiovascular disease.

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