Prof. Dr. F. Cankat Tulunay Honorary President of EACPT

MOH

DRUG COMPANIES

PATIENTS ACADEMICIANS SOCIAL

SECURIT AGENCY

PHARMACISTS DOCTORS

F.C. Tulunay, 2009

Actual Reasons For Healthcare Expenses

•  Ten reasons why it costs so much. Two of the ten add value: #1 and #2 improve the quality and length of our lives. Numbers 3 through 10 add no value. THAT is where you can save money without losing something we want. 1. Treatments available now that did not exist before 2. More people living longer 3. Action without evidence 4. Cost of regulations and compliance 5. Inefficiency 6. Perverse incentives 7. Defensive medicine 8. Adverse outcomes and errors 9. Profits taken out of healthcare system 10. Embezzlement and fraud (outright theft).

USA •  USA spends $2 trillion on healthcare.

•  $680billion (34%) "goes to" the doctors

•  $600b (30%) to hospitals •  $340b (17%) to outpatient services •  $300b (15%) to for medications.

  Costs of Cancer NIH estimated the 2008 overall annual costs of cancer were as

follows:

•  Total cost: $228.1 billion •  Direct medical costs (total of all health expenditures): $ 93.2

billion •  Indirect morbidity costs (cost of lost productivity due to

illness): $ 18.8 billion •  Indirect mortality costs (cost of lost productivity due to

premature death): $116.1 billion

•  About 24% of Americans aged 18 to 64, 13% of children had no health insurance for at least part of the past year.

•  This year, about 562,340 Americans are expected to die of cancer -- that's more than 1,500 people a day. Cancer is the second most common cause of death in the United States, exceeded only by heart disease. Cancer accounts for nearly 1 out of every 4 deaths in the United States

American Cancer Society. Cancer Facts & Figures 2009. Atlanta, GA. 2009.

6

LIFE AFTER CANCER – costs of cancer care

National Cancer Institute ● Cancer Trends Progress Report – 2005 Update ● http://progressreport.cancer.gov

Efficacy, safety, and cost of new anticancer drugs Silvio Garattini, director and Vittorio Bertele', head, regulatory policy laboratory

Mario Negri Institute for Pharmacological Research, 20157 Milan, Italy Correspondence to: S Garattini sgarattini@marionegri.it

BMJ. 2002 August 3; 325(7358): 269–271

•  New anticancer drugs reaching the European market in 1995-2000 offered few or no substantial advantages over existing preparations, yet cost several times—in one case 350 times—as much

•  The greatest changes have been 4500 fewer deaths from childhood tumours and 4000 fewer from lymphomas (Hodgkin's disease) each year over the past four decades.

•  Among solid tumours, advances have been made in treating breast cancer, in which tamoxifen increases 10 year survival by 6% for node negative and 11% for node positive tumours,3 and chemotherapy increases survival by 7% and 11%, respectively.4

•  For most other common solid tumours such as those of lung, oesophagus, stomach, or pancreas, only limited survival gains have been achieved.2,5,6

•  U.K. rejected NEXAVAR for liver cancer

•  Nexavar was estimated to cost 65,900 pounds ($102,000) for every “quality adjusted year of life,”

Not: •  NEXAVAR: 200 mg 112 tab: 8.270 TL

ödenmez (SGK)

Miracle Cancer Drug Extends Life With $48,720 Cost

March 05, 2010

  It was called SU11248 (SUTENT), and Pfizer Inc. had just acquired the company developing it. Tumors were shrinking in two thirds of the digestive tract cancer patients in the clinical trial Demetri had been running since February 2002. One dying man’s malignancy had stopped growing so suddenly after five doses that it was a “miracle,” the oncologist said.

BMJ. 2002 August 3; 325(7358): 269–271

•  Sunitinib is recommended, as a treatment option for people with unresectable and/or metastatic malignant gastrointestinal stromal tumours if:

•  imatinib treatment has failed because of resistance or intolerance, and

•  the drug cost of sunitinib (excluding any related costs) for the first treatment cycle will be met by the manufacturer.

•  The use of sunitinib should be supervised by cancer specialists with experience in treating people with unresectable and/or metastatic malignant gastrointestinal stromal tumours after failure of imatinib treatment because of resistance or intolerance.

SUTENT •  Costs •  Sunitinib is marketed by Pfizer as Sutent, and is subject to patents and

market exclusivity as a new chemical entity until February 15, 2021 •  Sutent is one of the most expensive drugs widely marketed. Doctors

and editorials have criticized the high cost, for a drug that doesn't cure cancer but only prolongs life.

•  In the U.S., insurance companies have refused to pay for all or part of the costs of Sutent.

•  In the UK NICE refused (late 2008) to recommend suntinib for late stage renal cancer (kidney cancer) due to the high cost per QALY, estimated by NICE at £72,000/QALY and by Pfizer at £29,000/QALY.[21] It was also refused by NICE in 2008 for the treatment of kidney cancer.[22] This refusal/guidance was updated Feb 2009 after negotiations on price for the first course of treatment

•  TÜRKİYEDE BİR SİKLÜS İLAÇ GİDERİ: 17.346 TL

'We'll sell our house for this drug (sutent)'

•  The treatments are used for advanced kidney cancers •  A row has broken out over the funding of four drugs

for advanced kidney cancer after the drugs advisory body NICE said they should not be available on the NHS.

•  Andrew Crabb, from Abingdon in Oxfordshire, got the news on the first anniversary of his diagnosis with the disease - but says he will do everything he can to carry on receiving his drug.

BBC news, 7 August 2008

•  FOLOTYN is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. (FDA Prospektüs)

•  The drug was approved by the Food and Drug Administration in late September as a treatment for peripheral T-cell lymphoma, 30.000 dolar/month

•  In the clinical trial, the median duration of use was 70 days, which would cost roughly $70,000 to $80,000. But some patients used the drug for many months.

•  Folotyn has not yet shown an effect on longevity. In the clinical trial that led to approval of the drug, 27 percent of the 109 patients experienced a reduction in tumor size. The reductions lasted a median of 9.4 months.

•  But considering all the patients in the trial, only 12 percent had a reduction in tumor size that lasted for more than 14 weeks. The trial did not compare Folotyn to another drug or a placebo.

•  Genzyme’s Clolar for pediatric leukemia costs about $34,000 a week, though the company says that only two weeks of treatment are typically needed.

•  GlaxoSmithKline is charging up to $98,000 for a six-month treatment course of Arzerra, a drug approved in late October for chronic lymphocytic leukemia

•  The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avastin about $8,800 when used to treat lung cancer.

GSK: Allen ROSES • A SENIOR EXECUTIVE WITH BRITAIN'S BIGGEST DRUGS COMPANY HAS ADMITTED THAT MOST PRESCRIPTION MEDICINES DO NOT WORK ON MOST PEOPLE WHO TAKE THEM.

•  DRUGS FOR ALZHEIMER'S DISEASE WORK IN FEWER THAN ONE IN THREE PATIENTS,

•  WHEREAS THOSE FOR CANCER ARE ONLY EFFECTIVE IN A QUARTER OF PATIENTS.

•  DRUGS FOR MIGRAINES, FOR OSTEOPOROSIS, AND ARTHRITIS WORK IN ABOUT HALF THE PATIENTS, ,

Dr. ROSES

Charles Nemeroff caught with his hands in the Glaxo till…

• “…From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo….”

GSK   COURT EXPOSED GSK/RESEARCHERS FRAUD

The court documents released as a result of one of the lawsuits in October 2008 indicated that GSK "and/or researchers may have suppress

  MISLEADING PUBLIC For 10 years, GlaxoSmithKline's marketing of the drug stated that it was "not habit forming". In 2002, the U.S. Food and Drug Administration published a new product warning about the drug, and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) declared GSK guilty of misleading the public about paroxetine on US television. ed or obscured suicide risk data during clinical trials"

Drugs Giants GlaxoSmithKline In Iraq Probe

•  Pharmaceutical companies GlaxoSmithKline and AstraZeneca have been linked to an investigation into bribes allegedly paid to Saddam Hussein's former regime.

•  The oil-for-food programme was supposed to allow the Iraqi government to sell limited amounts of oil to buy foreign food and medicines.

Is there an EVİDENECE-BASED pharmacotherapy?

PHARMACOTHERAPY

EVIDENCE BASED PHARMACOTHERAPY

OR

FRAUD BASED PAHARMACOTHERPY?

REGULATORY AGENCIES

PHYSICIANS

INDUSTRY

PHARMACYST

PATIENTS

RATIONAL DRUG USE

Hastaların klinik ihtiyaçlarına göre, ihtiyaç duyduğu dozda, sürede ve kendisi ve toplum için en ucuz maliyette ilaç bulabilmesidir. (WHO 1985)

l  Right indication l  Right drug l  Right route, dosage, duration l  Right patient l  Right patient information l  Rigtht evaluation l  Right price

l  Uygun endikasyon l  Uygun ilaç l  Uygun yol, doz ve süre l  Uygun hasta l  Uygun hasta bilgilendirilmesi l  Uygun değerlendirme l  Uygun fiyat

7U 7R

“Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.” (WHO, 1985).

WHO advocates 12 key interventions to promote more rational use:

1 Establishment of a multidisciplinary national body to coordinate policies on medicine use.....NO 2. Use of clinical guidelines.....NO 3. Development and use of national essential medicines list...NO 4. Establishment of drug and therapeutics committees in districts and

hospitals...NO 5. Inclusion of problem-based pharmacotherapy training in undergraduate

curricula...NO 6. Continuing in-service medical education as a licensure requirement: 7. Supervision, audit and feedback...NO 8. Use of independent information on medicines...NO 9. Public education about medicines...NO 10. Avoidance of perverse financial incentives...NO 11. Use of appropriate and enforced regulation...NO 12. Sufficient government expenditure to ensure availability of medicines

and staff...NO

Factors affecting irrational drug use

• Inadequate education

• Corruption • Unethical

practice • No prescription

control

Pharmacist

• Political pressure •  Inadequate

registration system •  Inadequate

reimbustment system

• No tratement guidelines

• No rational drug policy

• No pharmacoeconomy

• No..No..No..!!!!

Rule and Regulations Regulatory agencies

• Unethical practice by all means

• Fraud • Corruption • No-oto

control

Industry

• Inadequate graduate and post bgraduateeducation

• No drug information source

• Over loaded patient duty

• Prescription pressure:

• Industry • Patients • Promotions

• Unethical drug business!!

• Corruption

Physician

• Wrong information

• False informatin • Press, TV

• False beliefs • Unable explane

problems • No relaible

information source

• Self medication • Komşusunun

ilacını kullanma • Economical!

Patient

Tulunay 2008

Outcomes of irrational drug use

Degeneration of treatment quality

• morbidity • mortality

Waste of resources

Increased risk of adverse effect risk

• Unneeded expectations from drugs • Feeling of unhealing • Suicite

Psycho-social outcomes

• Decrease availability • Increased price

• Adverse reactions • Bacterial resistans

ECONOMICAL LOSTS COST OF HUMAN BEING? SHAME OF 21st CENTURY Tulunay 2008

Medical journals and pharmaceutical companies: uneasy bedfellows Richard Smith, editor

BMJ 2003;326:1202-1205 (31 May)

•  Free newspapers for doctors depend completely on income from pharmaceutical advertising, but many journals also depend heavily on such advertising

•  The advertising is often misleading •  Editorial coverage is much more valuable to drug

companies than advertising, and scientific studies can be manipulated in many ways to give results favourable to companies

•  Many medical journals have a substantial income from supplements and reprints paid for by drug companies

•  In one sense, all journals are bought by the pharmaceutical industry. The industry dominates health care, and most doctors have been wined and dined by it.

HADİ RICHARD...BİZ BİRBİRİMİZE MUHTAÇIZ

Future European health care: Cost containment, health care reform and scientific progress in drug research

G.Emilien, Int.J.Health Plan.Manag. 12:81-101, 1997

•  A= Terapoetic efficacy internationally proven

•  B= Second choise, open for abuse

•  C= Non-effective drugs (1993)

•  In Germany 4.128 billion dolar worth suspicious drug (1992)

Top 25 products Top 50 products

A B C A B C Not

necessary**

Italy 11 7 7 25 15 10 21.2

France 16 4 5 26 14 10 20.5

Germany 19 5 1 35 9 6 11.9

UK 24 1 0 46 4 0 NA

** % of total drug use

Another GARDASİL.... 806 TL CERVARIX.... 734 TL

!

8 October 2009, BMJ 2009;339:b3884 Cost effectiveness analysis of including boys in a human

papillomavirus vaccination programme in the United States Jane J Kim, assistant professor, Sue J Goldie, professor

1 Harvard School of Public Health, Department of Health Policy and Management, Center for Health Decision Science, 718 Huntington Avenue, Boston, MA 02115, USA

•  Given currently available information, including boys in an HPV vaccination programme generally exceeds conventional thresholds (QALY over 100.000$) of good value for money, even under favourable conditions of vaccine protection and health benefits

Hysteria over genital warts? New York Times,2008

•  In a New York Times article published last year, Dr. Harper spoke about the fear-based marketing of Gardasil by Merck: "'Merck lobbied every opinion leader, women's group, medical society, politicians, and went directly to the people -- it created a sense of panic that says you have to have this vaccine now..." This behavior by drug companies -- using fear tactics to promote a particular disease in order to sell the "treatment" -- is called disease mongering. Most of the pharmaceutical profits generated today are based on precisely this tactic: Spread the fear, then sell the treatment. Why is disease mongering so important to the profits of the drug companies? They figured out many years ago that selling drugs only to those people who are sick was a very limited income opportunity. To rake in the real profits, they needed to devise a way to sell drugs to healthy people (i.e. people who don't need them). That's what cervical cancer vaccines really are: A scheme to sell vaccines to people who aren't suffering from any disease at all. That one of the industry's own researchers is willing to speak out against this is not just highly unusual; it's also highly courageous. It makes you wonder: Who, exactly, is this Dr. Harper? Dr. Diane Harper

•  Dr. Harper is a graduate of the Massachusetts Institute of Technology. She studied additional courses at Stanford and received her medical degree from the University of Kansas. She was a key researcher in both Gardasil and Cervarix vaccines, and she's one of the most experienced researchers in the world on HPV-related diseases. She's done work for both Merck and GlaxoSmithKline.

Top researcher who worked on cervical cancer vaccine warns about its dangers

8.10.2009 www.NaturalNews.com •  One of the key researchers involved in the clinical trials for both Gardasil and Cevarix cervical

cancer vaccines has gone public with warnings about their safety and effectiveness. Dr. Diane Harper openly admitted the vaccine doesn't even prevent cervical cancer, stating, "[The vaccine] will not decrease cervical cancer rates at all." Dr. Harper also warned that the cervical cancer vaccine was being "over-marketed" and that parents should be warned about the possible risk of severe side effects from the vaccine. She even concluded that the vaccine itself is more dangerous than the cervical cancer it claims to prevent! Dr. Harper's warnings about cervical cancer vaccines are especially relevant considering her expertise in the cost/benefit analysis of vaccines. Her conclusion is that cervical cancer vaccines aren't worth the risks, nor are they worth all the effort being put into hyping them to the public. "This may not be the best use of our resources at this time," she said in a Washington Post article. So why do cervical cancer vaccines continue to be pushed by doctors and health authorities across the US, UK and other first-world nations? Because Big Pharma is the great corporate puppeteer that's pulling the strings of legislators. With enough money and lobbyists, you can always overcome scientific thinking with fear-based marketing and under-the-table deal-making. Science-based medicine has no place in a world where disease is big business.

Press Release For immediate release 9th October 2009

ALLIANCE FOR NATURAL HEALTH CALLS FOR AN URGENT SCIENTIFIC INQUIRY INTO THE HPV VACCINE USED IN THE UK

The Alliance for Natural Health (ANH) today calls for an independent Inquiry into the safety of HPV vaccine, and appeals to

all Members of Parliament to press for this.

•  Reports of serious and even lethal adverse reactions to the Human Papilloma Virus (HPV) vaccine, Cervarix, manufactured by GlaxoSmithKline, raises grave concern over the safety of the vaccine. While its closely related vaccine, Gardasil, manufactured by Merck, is recognised by the US Centers for Disease Control (CDC) to trigger severe reactions, namely hospitalisation, permanent disability, life-threatening illness or death, equivalent data in the UK appears not to be publicly available.

NEXAVAR?? (1month cost is 8.270 TL=5.500 USD) Which one is wright!!??

•  Bayer, Onyx Pill Doesn’t Slow Breast Cancer in Study Sept. 30 (Bloomberg) -- Bayer AG and Onyx Pharmaceuticals Inc.’s Nexavar cancer drug failed to slow the progression of breast cancer in the second of four studies that combine the medicine with different types of chemotherapy.

•  September 30, 2009 Mid-stage breast cancer trial of Bayer, Onyx's Nexavar misses primary endpoint Last Updated:September 30, 2009 00:30 Preliminary results showed that a Phase II trial of Bayer and Onyx’s Nexavar (sorafenib) in combination with paclitaxel in patients with advanced breast cancer did not meet its primary endpoint of progression-free survival, the companies announced on Wednesday. Dimitris Voliotis, vice president of global clinical development oncology at Bayer, said the “data require further analysis and interpretation before we determine the appropriate path forward."

• 

•  Wednesday - September 23, 2009 Phase II Study in Advanced Breast Cancer:

•  Nexavar® in Combination with Chemotherapy Demonstrates 74 Percent Improvement in Progression-Free Survival

•  First presentation of results at joint ECCO-ESMO congress in Berlin, Germany

•  Abstract # 3LBA Berlin, September 23, 2009 – Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo controlled Phase II trial showing that Nexavar® (sorafenib tablets) in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer by 74 percent. The data were presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin, Germany.

Bayer

FDA probe of Pfizer's anti-smoking drug continues

April 6 2009 •  The FDA is investigating reports of injury, visual

impairment and other problems connected with the medication, which is designed to ease smokers' withdrawal symptoms. The agency began probing the problems last fall.

•  The Federal Aviation Administration last year banned the use of Chantix by pilots after a spike in patients reporting blackouts, some of which led to traffic accidents

Source: IMS Management Consulting analysis

Size of bubble: Forecast sales 2009

500

A large number of innovative candidate makes the oncology

pipeline the largest in the industry

Innovative approaches set to drive strong

growth in oncology

0% 2% 4% 6% 8% 1%

12% 14% 16% 18% 20%

-50 0 50 100 150 200 250 300 350 400 450 # phase II & onwards pipeline products

Gro

wth

of sa

les

2004

-200

9*

Cardiovascular (C8, C9, C10A) Epoetins (B3C) PPIs (A2B2) Anti-platelet inhibs (B1C)

Oncology (L1, L2) CNS (N3A, N5A, N6A) Osteoporosis (M5B, G3H, H4A, H4V) HIV antivirals (J5D) Oral antidiabetics (A10B)

R&D Activity in Main Therapeutic Areas Innovation worries the decision maker

R&D Activity in Main Therapeutic Areas

41

e.g. New drug vs. current care

Net Savings

+ = physicians hospital surgery

other drugs tests

New New

Current

Current

Cost of drug Average Other Treatment Costs

Total Cost

New Current (health care payer perspective)

42

e.g. New drug vs. current care (2)

+ = physicians hospital surgery

other drugs tests

New

New

Current

Current

Cost of drug Average Other Treatment Costs

Total Cost

New Current

43

e.g. New drug vs. current care (3) Net Costs

+ = physicians hospital surgery

other drugs tests

New

New

Current

Current

Cost of drug Average Other Treatment Costs

Total Cost

New

Current

How do we value innovation?

•  Steve Pearson, President of the Institute for Clinical and Economic Review at Harvard, identified two options for judging innovation.

•  The first is by setting criteria for success before the innovation has been introduced, such as measuring whether an intervention works. Mr Pearson said this would be “difficult to do in a way which makes sense”, as it is hard to define criteria for an innovation’s success before the innovation itself has been created.

•  Another method of judging innovation would be to assess its performance once introduced. This again poses difficulties, as it depends on an agreed definition of “value”. Suggested definitions include the speed of penetration of the innovation into a healthcare system, or the destination of venture capital - which he said could be cosmetic surgery in the case of the US.

•  9 December 2009 44

45

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Evidence to support chronic myeloid leukaemia drugs "very poor"

•  NICE is unable to recommend the use of dasatinib and nilotinib for the treatment of chronic

myeloid leukaemia in patients who cannot tolerate the first-line treatment imatinib, after finding that the evidence to support their use is “very poor”.

•  Neither of the drugs fits the NICE end-of-life criteria, introduced to allow Appraisal Committees to consider expensive medicines licensed for terminal illnesses, as the available evidence on life extension is too weak.

•  But even if the end-of-life criteria had been met, the exceptionally high costs of dasatinib and nilotinib, taken together with poor quality evidence on the drugs’ effectiveness, would not allow NICE to consider the drugs a cost-effective use of NHS resources.

•  This latest draft guidance comes after the independent Appraisal Committee met, last month, to discuss issues around the cost-effectiveness modelling raised during the first public consultation.

•  Professor Peter Littlejohns, clinical and public health director at NICE, said: “The Committee heard from clinical specialists that in their opinion dasatinib and nilotinib are clinically effective. However, the evidence available to support this was very poor, with no studies comparing either drug to other treatments.

•  “The cost of the drugs is also extremely high and before committing limited NHS resources to fund them, we need to be sure they are effective. It would be heartening to hear that the pharmaceutical company manufacturers are prepared to share some of the very high cost of the drugs with the NHS.”

•  The independent committee will next met on 9 March 2010 to consider any further evidence before issuing the next draft guidance.

•  9 February 2010 47

48