Guide to Minimal Use of Neuroleptics: Why and How by Volkmar
Aderhold, MD and Peter Stastny, MD, June 2015
Rethinking Antipsychotics(pdf): Robert Whitaker, February 2017
Norwegian Psychiatric Society (NPF), TIPS, UiO: NORMENT: Norwegian Centre for Mental Disorders Research
Copy: Ingrid Melle, Jan Olav Johannessen, Health directorate
Neuroleptics are used to ease symptoms and to prevent relapse with evidence at the beginning of the psychosis for a minority of patients. There is no evidence that antipsychotics promote "psychosocial functioning, professional functioning, and quality of life" (Buchanan et al 2010 PORT Treatment Recommendations). Recovery treatment still wins terrain and will be put into a historical context. Mike Slade et al. 2014 describes the implementation of recovery with both usage and abuse of the term. Why is there still resistance despite very good treatment outcomes of recovery orientation such as Open dialogue (2)? How can a paradigm shift be made in the interest of patients' health and health professionals who want their efforts to benefit many more patients?
“In the 1950s, when the drugs we now call ‘antipsychotics’ first came along, psychiatrists recognised that they were toxic substances that happened to have the ability to suppress thoughts and emotions without simply putting people to sleep in the way the old sedatives did” (Joanna Moncrieff, MD 13. August 2013; Deniker P. Compr Psychiatry 1960 Apr;1:92-102.). Mainstream psychiatry was uncomfortable with the notion that its principle treatment worked by being a neurological toxin and transformed it into a sophisticated, treatment. At last the misleading expression “antipsychotics” was chosen.
Recovery is used in several meanings and has gained attention and has now become mainstream. WHO's Mental Health Action Plan 2013-2020 is with emphasis on recovery. The Government's Strategy for Good Mental Health (2017-2022) "Mastering Life" is based on WHO's plan and The European Mental Health Action Plan 2013-2020 and. EU JOINT ACTION 2016. Both the United States, Canada, New Zealand, Australia, the UK and Ireland are building their national strategies on recovery. The Norwegian Mental Health Expansion Plan mentions the needs of the user/patient as a starting point, "mastering one's own life", "successful return to working life" and "entering into a social relationship with family and friends" (Ottar Ness 2015). HOD has signalled to be positive. There is a long way to go to achieve a paradigm shift away from diagnosis and symptom treatment to the goal of recovery / recovery.
In Norway, e. g. Bjornestad, Jone et al. 2017 and 9 other researchers addressed the recovery perspective with the paper "Antipsychotic Treatment: Experiences of Fully Recoveryed Service Users". In collaboration with the NAPHA, 2013, "Recovery-oriented practices - a systematic knowledge-sharing" was launched. Illness Management and Recovery (IMR) is evidence-based treatment with good effect for schizophrenia, bipolar disorder and severe depression. Open Dialogue was developed in Finland and is being used in several Scandinavian countries (2). In Valdres (Norway), the Odin Handbook (Open Dialogues in Network meetings) was developed. Drug-free treatment offerings at Åsgard Hospital in Tromsø (UNN) seem to have come a long way (1).
The discussion on drug-free offers in mental health care has exposed internal conflicts of psychiatry (Journal of Norwegian Medical Association No. 6, 21 March 2017). Do old truths stand for fall? Could it indicate changes? Are we heading for a paradigm shift?
Open dialogue reports more than 80% recovery and the incidence of psychoses was reduced from 33 to 2 per 100,000 inhabitants per year (2, 12).
Open dialogue uses approx. 60% less neuroleptics (antipsychotics) for maintenance treatment and achieves more than 60% increase in recovery (2, 12). Open dialogue reduces disability allowance/sickness to one third.
Bjornestad, Jone et al. 2017 found in "Antipsychotic treatment: experiences of fully recovered service users": "(b) etween 8.1 and 20% of service users with FEP achieve clinical recovery (Jaaskelainen et al. 2013)" with treatment as usual according to the standard guidelines.
Why are Open Dialogues (2) spectacular good treatment results not of interest? Why is there no research to find out what the results are due to?
Neuroleptics (improperly called antipsychotics) were considered to be major advances in treatment. "Antipsychotic drugs revolutionized the care of schizophrenia, changing it from an incurable condition which required institutionalization to one that could be treated in the community, with the potential for independent living and recovery" concludes Professor Lawrie, as late as February 24, 2011 . NORMENT is based on its research: "Antipsychotic drugs are effective drugs for schizophrenia and have also been used in recent years for bipolar disorder."
In early episode schizophrenia research, the suggestion that postponing administration of antipsychotic medications may result in a poorer clinical course has raised the parallel ethical consideration of whether there is harm to subjects through “deferring neuroleptic treatment in first-episode patients while studies are conducted.” (John R Bola, 2005).
However, in a recovery perspective, it now appears that the treatment results (8.1 to 20% recovery) are very bad in the long term (3). Psychiatry seems to hold that current antipsychotics over-medication is effective in declaring schizophrenia as a chronic disease that requires lifelong medication.
One of the problems is the confirmation bias. It was easy for confirmations and conflicting information to be overlooked. Very simple is to see if the disease returns (recurrence) upon discontinuation of neuroleptics: " Reoccurrence of symptoms after discontinuation is an effect of discontinuation, not just an effect of the disorder." (Journal of the Norwegian Psychology Association , Vol. 52, No. 2, 2015 pages 126-131). This also applies to research: Bola et al. Cochrane.org 2011 found only 5 studies that were real placebo studies. One of these studies, Rappaport et al. 1978, found that unmedicated patients managed better, e. g. regarding readmission to hospital: NNH 2.9 (NNH = number nead to harm). The length of Follow-Up of this study was 3 years.
One was so convinced of the excellence of neuroleptics that there is no research comparing antipsychotics medication with psychosocial treatment or physical activity even though the effect of physical activity is documented (Gorczynski P, Faulkner, G 2010).
In spite of this research error which burdens the "placebo" group with withdrawal effects, the positive effects are small:
Reduction of 50% or more of psychotic symptoms are achieved according to Leucht et al 2009 effect of “(overall 41 versus 24% responded under SGA drugs and placebo, respectively) or an NNT of 6” i.e. for a small minority (1 in 6 patients) at the beginning of psychosis. Studies cover short-term and mid-term length. The Paulsrud committee found the same effects (1 in between 5 and 10 patients).
Leucht et al 2012 deals with maintenance treatment with neuroleptics. The studies range from 7 to 12 months. The results for preventing readmission are 1 in 5 patients (NNT = 5) and the conclusions for further research are "focus on outcomes of social participation and clarify the long-term morbidity and mortality." "Nothing is known about the effects of antipsychotic drugs compared to placebo after three years "(Leucht et al. 2012, p. 27).
There is no evidence of maintenance treatment for more than 3 years (FHI: ISBN 978-82-8121-958-8). Bjornestad, Larsen et al. 2017 admits that evidence of maintenance medication is missing: "Due to the lacking long-term evidence base (Sohler et al. 2016) ..." Thus, positive effects for patients are not evidence-based after 3 years and the probability of evidence-based positive effects is strict taken zero.
Symptoms relief (12) and relapse prevention (Leucht et al 2012) are achieved only for a small minority in the beginning, RCT evidence beyond 3 years lacks completely and long-term use co-varies with more than approx. 40% reduction in recovery and approx. 40% increase in disability disability allowance/sickness (12). Nevertheless, psychiatry professors Jan Ivar Røssberg, Ole A. Andreassen, Stein Opjordsmoen Ilner (who educate psychiatrists) has a change-resistant, unrealistic and knowledge-resistant misrepresentation that antipsychotics contribute for "the vast majority contributing to the symptoms, functioning and higher self-reported quality of life. "(Doctors Journal, 12.05.2017). This delusion prevents the opening of drug-free treatment (3,4) in the psychosocial guidelines ("experimental, unethical", Larsen: "giant mistake", professional irresponsibility) and legitimises illegal forced medication. There is no evidence that antipsychotics promote "psychosocial functioning, professional functioning, and quality of life" (Buchanan et al 2010 PORT Treatment Recommendations). The county administration's practice regarding complaints against forced medication has been weakened by naive unscientific belief in psychiatrists' allegations and delusions. The county governor legitimises it by just giving 3% of the complaints pursuant and thus appears as a ridiculous appeal body (Ketil Lund). The Civil Ombudsman points out in law and order 05/2017 (Volume 56). Mental Health and Forced Medicine: "We are here in the core area of the principle of legality: Forced medication should not occur without the requirements of the law being met." Actually, "forced medication must be forbidden" (Ketil Lund).
Harrow, M. & Jobe, T.H. (2012), Harrow et al 2014 (12) Long-term study shows that patients diagnosed with schizophrenia subject to drug-free treatment manage better in the long run, ie 50% significantly improved (higher recovery rate) after 15 years compared with 5%.
Wunderink randomized study replicated results. After 7 years, 40.4% recovery recovered and 17.6% with neuroleptics (12).
Harrow, M. & Jobe, T.H. (2017) concludes in "A 20-Year Multi-Followup longitudinal study assessing whether antipsychotic medications contribute to work functioning in schizophrenia":
"Negative evidence on the long-term efficacy of antipsychotics has emerged from our own longitudinal studies and the longitudinal studies of Wunderink, of Moilanen, Jääskeläinena and colleagues using data from the Northern Finland Birth Cohort Study, by data from the Danish OPUS trials (Wils et al. 2017) the study of Lincoln and Jung in Germany, and the studies of Bland in Canada, "(Among RC and Orn H. (1978): 14-year outcome in early schizophrenia; Acta. Psychiatrica Scandinavica 58,327-338) the authors write. "These longitudinal studies have not shown positive effects for patients with schizophrenia prescribed antipsychotic for prolonged periods. I tillegg til resultatene som indikerer rariteten af perioder med fuldstændig recovery for patienter med schizofreni-antipsykotika for forlængede intervaller, vores Research has indicated a significantly higher rate of periods of recovery for patients with schizophrenia who have gone off antipsychotics for prolonged intervals. "
Studies suggest that using minimal dose of neuroleptics for fewer patients over shorter time (Alvarez-Jimenez, Wunderink et al. 2016) is beneficial.
«A Guide to Minimal Use of Neuroleptics: Why and How by Volkmar Aderhold, MD and Peter Stastny, MD, June 2015» shows the benefit of using minimal neuroleptics both low doses and fewer patients.
Bola and Mosher 2003 compares Therapeutic Milieu vs Medications in the Hospital. Mean Effect Size (r) = 0.19 in favour of therapeutic milieu. Completing subjects had significantly better composite outcomes of a medium effect size at Soteria (+.47 SD, p =.03). Completing subjects with schizophrenia exhibited a large effect size benefit with Soteria treatment (+.81 SD, p =.02), particularly in domains of psychopathology, work, and social functioning. In addition, only 58% of Soteria subjects received antipsychotic medications during the follow-up period, and only 19% were continuously maintained on antipsychotic medications.
Jaakko Seikkula et al. 2010 (Journal Psychosis Volume 3, 2011 - Issue 3) found more than 80% recovery long-term effect for first-episode psychotic patients treated with Open Dialogue Therapy in Western Lapland (2, 5, 12): This shows the benefits of using not a lot of medications supported by psychosocial care. 19% were invalidated or sick after 5 years with 17% on neuroleptics (Scientific Symposium). With 75% on neuroleptics following the guideline guidelines, 62% were invalidated or ill after 5 years (12). This corresponds to approximately 40% increase in disability allowance/sickness. The incidence of psychosis was reduced from 33 to 2 per 100,000 inhabitants per year (5, 12).
therapy has shown effect for individuals diagnosed with
“schizophrenia” and persistent psychotic symptoms who are taking
et al., 2008, Burns
et al., 2014, Pilling
et al., 2002). A positive therapeutic relationship, i.e. a “good
therapeutic fit,“ seems to be the most salient factor for its
effectiveness rather than any specific psychotherapeutic method, as
documented quite well by Wampold
Moritz S, et al. (2014) Sustained and "Sleeper" Effects of Group Metacognitive Training for Schizophrenia: A Randomized Clinical Trial. “Metacognitive training demonstrated sustained effects in the reduction of delusions, which were over and above the effects of antipsychotic medication” (after 3 years).
John R Bola. 2005 (Medication-Free Research in Early Episode Schizophrenia: Evidence of Long-Term Harm?) found more then 4 studies showing positive effects of some weeks medication free treatment after some years.
There is research that shows evidence for drug-free alternatives (4).
Rappaport et al. 1978 compares Hospital Milieu vs Medications in the Hospital. Mean Effect Size (r) = 0.18 in favour of hospital mileu. The 27% rehospitalization rate among placebo completers (11 of 41) is significantly lower than the 62% rate (34 of 39) among medication completers (r = −.32; study effect: r = −0.18). The length of Follow-Up of this study was 3 years.
Lehtinen et al. 2000 compares «Family Intervention vs Family Intervention plus Medications» Mean Effect Size (r) = 0.16 in favour of family intervention only.
Effects of physical activity for diagnoses schizophrenia is documented by Gorczynski P, Faulkner, G 2010. «Two trials compared exercise to standard care and both found exercise to significantly improve negative symptoms of mental state (Mental Health Inventory Depression: 1RCT(randomised controlled trial), n=10, MD(medium diffenrence) 17.50, PANSS negative (symptoms): 1RCT, n=10, MD -8.50).).»
Both Rathod et al 2010, Sarin et al 2011 and Swati et al 2011 show evidence of cognitive therapy for schizophrenia. Hutton P, Taylor PJ 2014 "Cognitive behavioral therapy for psychosis prevention: a systematic review and meta-analysis" compares medicated and unedicated and finds that CBT is associated with a reduced risk of transition to psychosis.
Morrison et al. 2012 (9) concludes "A response rate analysis found that 35% and 50% of participants achieved at least a 50% reduction in PANSS (syptomer) total scores by than of therapy and follow-up respectively» this corresponds to NNT = 2 for « follow-up »with the aid of cognitive therapy, ie, only 2 patients must be treated for an additional patient to recover. With neurroleptics, it is 6 according to Leucht et al. 2009.
Francesca Bohn Vitzthum et al. 2014. Individualized metacognitive therapy program for patients with psychosis (MCT+): introduction of a novel approach for psychotic symptoms. “Conclusions: The present case history lends preliminary evidence for the feasibility of this new treatment approach in psychosis.”
Morrison et al. 2014 shows in "Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomized controlled trial." “INTERPRETATION: Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs.”
Jauhar et al. 2014 «Cognitive-behavioral therapy for the symptoms of schizophrenia: systematic review and meta-analysis with examination of potential bias» shows therapeutic effect.
“Experiential Competence” writes April 28, 2014: "Psychotherapy for psychosis works" and refers to Michael Balter's "Talking Back to Madness" in the prestigious journal Science 14 Mar 2014: Vol. 343, Issue 6176, pp. 1190-1193. DOI: 10.1126 / science.343.6176.1190.
Ryan et al 2015. Metacognitive therapy (MCT+) in patients with psychosis not receiving antipsychotic medication: A case study. “Conclusions: The presented case studies provide preliminary evidence for the feasibility of MCT+ in treating patients not taking, or resistant to, antipsychotic medication.”
Spectrum Disorders Fønhus MS, Fretheim A, Johansen M. has in "Drug-free Measures in Mental Health Protection" (Note from 2016. Oslo: Public Health Institute, 2016) found many drug-free treatments.
Eichner, C., & Berna, F. (2016). Acceptance and efficacy of metacognitive training (mct) on positive symptoms and delusions in patients with schizophrenia: A meta-analysis taking into account important moderators. Schizophrenia Bulletin, 42(4), 952–962 viser evidens.
Liu, Y.-C., Tang, C.-C., Hung, T.-T., Tsai, P.-C., & Lin, M.-F. (2017). The efficacy of metacognitive training for delusions in patients with schizophrenia: a meta-analysis of randomized controlled trials informs evidence-based practice. Worldviews on Evidence-Based Nursing.
Paul M. Grant et al., 2017, shows in the "Six-Month Follow-Up of Recovery-Oriented Cognitive Therapy (CT-R) for Low-Functioning Individuals With Schizophrenia" in a randomized study that "CT-R produced durable effects that were present even among individuals with the most chronic disease. "
This illustrates Klingberg's point (2012) that cognitive therapy has no evidence problem but an implementation problem (4, 10).
Professor, Dr. Med. Peter C. Gøtzsche supports medicine-free treatment. Robert Whitaker looked 2016 at “Recovery Rates and Long-term Outcomes for Unmedicated Patients with Schizophrenia.” The findings where promising.
In addition to the Open Dialogue (2), there are several other alternatives to TAU (Treatment as usual): Recovery-Oriented Cognitive Therapy (CT-R), SOTERIA APPROACH, HEARING VOICES APPROACH, HARM REDUCTION APPROACH (Will Hall), SHARED DECISION MAKING (Deegan, 2007; Deegan & Drake, 2007; Roe & Swarbrick, 2007) (15).
Diagnosis has long tradition, but there has been met with increasing criticism. Rosenhahn experiment showed that psychiatric diagnosis is not reliable. Professor Sami Timimi has looked if there is evidence that diagnosis hjelps. The result was that diagnosis should be abandoned because there is not sufficient evidence that it helps.
Only little effect of symptom reduction in the beginning (Leucht et al 2009), no evidence for effect after three years (Leucht et al 2012), no evidence for promotion of recovery (Buchanan et al 2010 PORT Treatment Recommendations) and the excellent recovery results (Seikkula 2014) of Open dialogue with 83% unmedicated long-term (5, Seikkula 2016) have raised the question if antipsychotics do more harm then good in the long term.
What is the possible harm?
There have been questions about increased drug use of neuroleptics and antidepressants and increased disability benefits have a connection: Whitaker: Causation, Not Just Correlation: Increased Disability in the Age of Prozac (6).
Clare Parish found that brain volume shrinks ("Antipsychotic deflates the brain") also see Andersen et al. The reduction in brain volume due to prolonged "antipsychotic" use reduces cognitive abilities (PLOS Medicine: Antipsychotic Maintenance Treatment: Time to Rethink? Joanna Moncrieff. Published: August 4, 2015).
Psychiatric patients have approx. 25 years shorter life. Recent research recommends reduced long-term use of antipsychotics to increase life expectancy for patients (Athif Ilyas et al, 2017). PETER C. GØTZSCHE, Professor, Dr. Med., Rigshospitalet Copenhagen writes "(T)o sum up, psychotropic drugs are the third most common cause of death in Western countries after cardiovascular disease and cancer." (7). In 'Deadly psychiatry and organized denial' (2015) P. Gøtzsche writes: "we could reduce our current usage of psychotropic drugs by 98% and at the same time improve patients' mental and physical health and survival"(8). Professor Peter C Gøtzsche concludes 10. January 2018 «Psychiatry is a disaster area in healthcare that we need to focus on» (BMJ 2018;360:k9).
It appears that recovery in the longer term was better before neuroleptics were introduced (8). The national guidelines to treat psychosis in Norway refer to recovery. However an additional 5 years of long-term medication is proposed in the case of relapse after 2 years. Leucht et al. 2009 with symptom relieve for 1 in 6 patients is included in the reference list. Nevertheless, it is stated that "50-80% of patients who receive effective medicine will be significantly better" on the basis of outdated studies from the 1990s and that the placebo effect seems to be added. Therefore all diagnosed schizophrenia are offered drugs. Thw result is that TIPS prosject medicated all, Svedberg et al. 2001 93%, and in Australia more then 90% tok psykotropic medicine (Waterreus et al., 2012).
From an evidence-based point of view, the current practice of long-term medication is an experimental, unethical chance game that is incorrect. Experience and cohort studies show that long-term recovery is seriously impaired. Here the doctor's principle is touched "first, do no harm." It is encouraged that over-medication practice is terminated in favour of evidence-based health promotion practices that take care of recovery opportunities, i.e. the health of the patients (12).
Peter C Gøtzsche concludes 10 January 2018 (BMJ 2018;360:k9): «Psychiatry is a disaster area in healthcare that we need to focus on» (16):
Firstly, the effects of psychiatric drugs are not specific.
Secondly, the research in support of the paradigm is flawed
Thirdly, the widespread use of psychiatric drugs has been harmful for the patients.
Fourthly, all attempts at showing that psychiatric disorders cause brain damage that can be seen on brain scans have failed.
There are four main problems with psychiatric drug trials:
Almost all placebo-controlled trials are flawed due to their cold turkey design
The trials are insufficiently blinded
Psychiatrists assess the effect using rating scales, the relevance of which for the patients is often uncertain
Selective reporting of outcomes is very common and can be very serious
Psychiatry needs a revolution. Reforms are not enough. We need to focus on psychotherapy and to hardly use any psychiatric drugs at all.
Rindal, 10. January
Pasientenes erfaringer med fravær av beskyttelse mot helseskadelig behandling, menneskerettigheter, demokrati og rettssikkerhet
Robert Whitaker - March 25, 2017. The Door to a Revolution in Psychiatry Cracks Open. A MIA Report: Norway's Health Ministry Orders Medication-Free Treatmen https://www.madinamerica.com/2017/03/the-door-to-a-revolution-in-psychiatry-cracks-open/
Jaakko Seikkula - 7 Principles of Open Dialogue - DK 3 - Roskilde- August 29, 2014: 3. http://home.broadpark.no/~wkeim/files/Seikkula2014.pdf
Knowledge- and research-based liquidation of current harmful psychiatric medication in favour of evidence-based practice to promote recovery http://home.broadpark.no/~wkeim/files/open_letter_knowledge.html
Sami Timimi. Tidsskr Nor Legeforen 2017 137:421 DOI: 10.4045/tidsskr.17.0240 The option of drug-free/drug withdrawal is the minimum that all http://tidsskriftet.no/comment-view/11126
Scientific Symposium. Pharmaceuticals – risks and alternatives. The 15th of October 2016 in Gothenburg, Sweden. Jaakko Seikkula, Professor of Psychotherapy, Clinical Psychologist, Finland. Naturalistic study designs for developing the system to reduced medication http://extendedroom.org/en/scientific-symposium/
Robert Whitaker: Causation, Not Just Correlation: Increased Disability in the Age of Prozac: https://www.madinamerica.com/wp-content/uploads/2017/01/Causation-not-just-correlation-.pdf
Professor, Doctor of Medical Science, Peter C. Gøtzsche The third leading cause of death after heart disease and cancer?: http://cepuk.org/2015/05/13/third-leading-cause-death-heart-disease-cancer-experts-debate-harmful-effects-psychiatric-medications/ (in Danish: http://www.deadlymedicines.dk/wp-content/uploads/2015/09/Diagnoser_kap-7.pdf
Professor PETER C. GØTZSCHE: Deadly Psychiatry and Organised Denial (pdf). https://www.amazon.com/Deadly-Psychiatry-Organised-Denial-Gotzsche-ebook/dp/B014SO7GHS
Morrison AP, Hutton P, Wardle M et al.
Psychological Medicine. Volume 42, Issue 5 May 2012, pp.
therapy for people with a schizophrenia spectrum diagnosis not
taking antipsychotic medication:
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Klingberg S, Wittorf A. Evidencebased psychotherapy for
schizophrenic psychosis. Nervenarzt 2012; 83:
Robert Whitaker, February 2017: Rethinking Antipsychotics Recovery Rates and Long-term Outcomes for Unmedicated Patients with Schizophrenia Spectrum Disorders (pdf)
Is it possible to give a rough guess on the
long-term effect/harm of antipsychotics on
Peter C. Gøtzsche. Professor, dr.med. Det Nordiske Cochrane Center Rigshospitalet, København: «Medicinfri psykiatri er veldokumenteret og tvangsmedicinering skal afskaffes» http://www.deadlymedicines.dk/wp-content/uploads/2017/05/Gøtzsche-til-Tidsskriftet-om-medicinfri-psykiatri.pdf
Peter C. Gøtzsche. Professor, dr.med. Medicinfri psykiatri. Tidsskrift for Den norske legeforening. http://tidsskriftet.no/comment/11179
A Critical Literature Review of the Direct, Adverse Effects of Neuroleptics (also known as antipsychotics). Essential Information for Mental Health Consumers, Carers, Families, Supporters and Clinicians: https://nmhccf.org.au/sites/default/files/docs/nmhccf_-_clr_-_web_accessible_version_-_final_-_august_2017_0.pdf
Peter C Gøtzsche 10 January 2018 Psychiatry is a disaster area in healthcare that we need to focus on (BMJ 2018;360:k9) http://www.bmj.com/content/360/bmj.k9/rr-15
Results of long-term use of antipsychotic drugs: