Sunday, March 1, 2015

Uncertain Health in an Insecure World – 25

“Global Unfair Exchange of Drugs”

Sir Nigel Crisp, the former U.K. National Health Service chief executive and Secretary of Health, recently described an “unfair exchange” – the importation of health care workers and exportation of U.S. and Euro-centric ideologies of what is “good” health.
This blog has previously discussed the nearly $1 trillion global pharmaceuticals market (see post #23), and that ~50% of world-wide sales are in the U.S. QUESTION: Does developed world new drug development do people living in less developed countries any “good”?

According to EvaluatePharma’s 2015 report, the top-10 global medical indications for drug sales are Type-2 diabetes, hypertension, rheumatoid arthritis, HIV, Hepatitis C (HCV), multiple sclerosis, asthma, hyperlipidemia, breast cancer and chronic obstructive lung disease (COPD).  Several of these are so-called ‘lifestyle diseases’, which could be prevented by healthy diet habits and smoking cessation. Star Trek’s Mr. Spock, Leonard Nimoy, warned of smoking dangers long before his recent death from COPD at age 83.
Their investor-focused 2015 projection of bio-technologies and small molecules expected to enjoy >$1 billion blockbuster worldwide sales by 2020 includes long-acting insulin, and drugs for LDL cholesterol lowering, asthma, psoriasis, cystic fibrosis, heart failure, pulmonary hypertension, schizophrenia and (of course) many solid and liquid cancers.

Big Pharma’s current blockbusters include drugs for diabetes, lipid-lowering and COPD, as well as expensive new immune-modulators and monoclonal antibodies (Mab’s) for cancers and rheumatoid & sero-negative arthritis. Serious diseases related to altered immunity (autoimmunity) or programmed cell death (apoptosis) may soon be improved by immune-modulators. Small molecule blockers of Protein Cell Death Ligand (PD-L1) binding to T-cell expressed Protein Cell Death-1 (PD-1) receptors are an exploding new drug class. 
Not much else is expected to change regarding the top disease-targeting drugs by 2020, with the exception of a new Biogen Idec drug for multiple sclerosis and a new Sanofi interleukin-antagonist Mab for eczema.

Of note, while the top-10 world-wide chronic diseases are expanding in the un- and under-developed world (see post #10), causing significant morbidity and mortality, the only U.S. FDA-approved and late phase III research new drug that is likely to impact sub-tropical and tropical populations is a Dengue Fever vaccine from Sanofi. 

The WHO estimates that >170 million people world-wide have HCV infection. Treatment with Gilead’s new antiviral, Sovaldi, currently costs US$84,000 in the U.S., US$66,000 in the U.K. and US$57,000 in Germany. In 2014, Gilead tried to deeply discount Sovaldi treatment to US$900 through deals with Egypt's government-run health system (per capita GDP = US$3,243), and with India’s generic drug maker Sciences (per capita GDP = US$1,499).  In 2015, an Indian patent for Sovaldi production was denied, threatening Gilead’s low price plan.  
The India Patent Office had previously rejected Novartis’ 2013 attempt to obtain patent protection for its anti-cancer drug Glivec. Médecins Sans Frontières Executive Director Dr. Manica Balasegaram criticized Gilead for requiring “providers in developing countries to comply with a web of onerous and potentially harmful procedures that aim to preserve Gilead’s ability to charge exorbitant prices in developed countries.

Giving Gilead the benefit of the doubt, we could consider the Sovaldi price break a form of corporate social responsibility (CSR). Cynically speaking, it could also be selective cost-shifting to achieve large population market entry (i.e., health care market ‘cherry picking’). Jansen’s Global Public Health CSR initiative appropriately fosters important research on neglected tropical diseases (NTD) and on multi-drug resistant tuberculosis (MDR-TB) resulting from TB under-treatment in China, Russia, India and sub-Saharan Africa.

In reality, only rich countries can afford these amazing breakthrough drugs, which are sold there at high prices designed to recoup their R&D and M&A costs before patent protection is lost. Poor countries of the world must still get by on older “bread and butter” treatments that they can afford. Differential drug pricing in wealthy versus poor countries creates major public trust issues for Pharma.

Offsetting rising public health care expenses with private sector Pharma profits may be a developed world market-based ‘value proposition’.‘Ethical’ Pharma’s use of in-country generic drug producers may not be in the best interests of local patients, but it does assure long-term commercial success for U.S. and European pharmaceutical interests.

What is clear is that Pharma’s profits are again steadily rising, and are projected to improve through 2020. What is unclear is whether the global “unfair exchange” of drugs is helping or harming the health of those becoming ill in poor countries.

While U.S. and Euro-centric ideologies often permeate the Square, we must reject the "good" not done when these views patently ignore universal rights to good health. 

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