Fire in the Blood, a film by Punjabi-Irish writer-director Dylan Mohan Gray was first released at the Sundance Film Festival in January 2013. Since then, it made blood boil on at least several continents. In Global Health Check February 2013, Araddhya Mehtta blogs that the documentary film covering Africa before HIV/AIDs mass treatment programs got underway “tells a harrowing story of inhumanity and heroism” and details how “millions upon millions of people, primarily in Africa were left to die horrible, painful deaths, while the drugs which could have saved them were being safely and cheaply produced and distributed just a short airplane ride away.”
She goes on to tell how the film accuses multinational drug companies and Western Governments of collaborating “to keep low-cost generic AIDS drugs out of the hardest hit countries.” According to Mehtta, film director Gray described the story as a “real-life David vs. Goliath tale, full of incredibly interesting, daring, courageous mavericks, who took on the world’s most powerful companies and governments to do what virtually everyone else at the time said was impossible (i.e. mass treatment of HIV/AIDS in Africa), and against all odds they won…”
Mehtta and Gray fail to mention some pertinent facts that present an altogether different picture.
First, the global health community and the Clinton Administration throughout the 1990s did not fund any HIV/AIDS overseas treatment programs. They advocated only preventive programs, such as testing, counseling, and condoms. The notion that Africans would agree to testing for the HIV/AIDS virus with the associated stigma and no available treatment was always puzzling to me. President Thabo Mbeke in South Africa was in denial of the entire AIDS epidemic. According to Roy Caroll, “He questions the link between viruses and AIDS, and believes that the correlation between poverty and the AIDS rate in Africa was a challenge to the viral theory of AIDS.” So it’s hard to see who the real “courageous mavericks” were in the 1990s and early 2000s.
It wasn’t until George W. Bush came into office and completely reversed the U.S. Government position against treating AIDS that the global health community changed its tune. President Bush ushered in treatment and created the well-known PEPFAR program in early 2003 which combined prevention and treatment for the first time for patients in poor countries hardest hit by AIDS. Only then, in December of 2003, did the WHO initiate its own program which included treatment for the first time.
Secondly, for Mehtta to proclaim, without any examination of the evidence, that there were “safely and cheaply produced” drugs just a short airplane ride away is misleading. She seems to be referring to Indian companies that were producing knock-off HIV/AIDS drugs for export. It’s safe to say that the drugs were cheap, but not that they were safe since India requires no bioequivalence testing on drugs for export. The chickens came home to roost in May of 2004 when the WHO recalled 36 Indian drugs from the market and mainly in Africa because the Indian companies could not provide proof of bioequivalence. And, while India was the epi-center of low cost production of ARVs, it had as difficult a time of providing treatment to its own patients as to those in the global arena. In October 2006, the International Treatment Preparedness Coalition criticized India for having 785,000 patients eligible for ARV treatment while only 6% of them were receiving it.
What Mehtta and the film do not acknowledge is the role of the U.S. Government’s FDA, which in May 2004, in an effort to increase AIDS drugs for poor countries, offered to accept any ARV drug file for review from companies in any country that wanted FDA certification to confirm that their drugs were valid ARV generics. In turn, U.S. companies, also wanting to increase AIDS drugs for poor countries, did not challenge the Indian companies for violating their patents. This made it possible for the U.S. Government to purchase these drugs and expand distribution even though the price differentials between the Indian and U.S. ARVs were not that significant.
This successful and innovative program between the U.S. Government and companies resulted in the number of AIDS patients being treated increasing from 400,000 in 2004 to more than 8 million patients by the end of 2012. Eighty percent of these patients were receiving Indian drugs, but this time, they were drugs that had been tested for safety and efficacy. And finally, even before President Bush allowed treatment of AIDS patients in U.S. programs, and the global health community followed suit, U.S. companies spun into action with multi-country and single country HIV/AIDS programs for vulnerable populations overseas. From 2000 through 2011, companies donated some $76 billion in drugs – often ARVs, and $9 billion in cash donations including capacity building and physical infrastructure. These contributions are greater than the combined health budgets of the World Bank, WHO, and USAID over the same time period.
The story of HIV/AIDS deserves a better documentary than Fire in the Blood if we are to ever learn from our mistakes for future pandemics. Yes, the story of HIV/AIDS is a sad story of unnecessary human suffering, but the film is missing the chapter on how global health experts endorsed only preventive programs without treatment for over a decade. Yes, ARVs were blocked from reaching Africa but primarily by health policy makers, not in a conspiracy of governments and companies. Yes, it did take some courageous mavericks to set it right, but not the ones generally mentioned, rather President Bush, the U.S. FDA, Dr. Paul Farmer who was the first to demonstrate that AIDS treatment could work in resource-constrained environments, and NGOs that stood their ground on the importance of both prevention and treatment. Documentary filmmakers should at least provide a balanced story and “do no harm” when they turn their cameras to life and death matters.
On May 26, 2012 the World Health Assembly (WHA) adopted a resolution calling for an inter-governmental meeting to examine the proposals made in April by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) to initiate a Global R&D Convention. It called for “open approaches to R&D, pooled funds, direct grants to companies in developing countries, prizes for milestones and end products, and patent pools”. The main recommendation of the CEWG was, however, more far-reaching: “to start multilateral negotiations for the possible adoption of a binding convention on health R&D”.
The concept of a Global Convention rests on three main premises:
- 1) “the current R&D model, based on patents and market-oriented research, fails to generate new health technologies to face global challenges arising from existing health needs, particularly in developing countries;
- 2) it is necessary to secure product access and affordability by delinking R&D costs from the prices of products; and
- 3) voluntary financing cannot be the main or unique source of funding—a better, more sustainable and predictable financing model is needed”.
In April 2012, Medecins sans Frontiers (MSF) stated: “the current R&D system is driven by market forces, not health needs, and relies overwhelmingly on the patent system to recoup costs by via high prices”.
How relevant are these premises to issues to the the Millennium Development Goals (MDGs)? In both cases, WHO was designated by the UN as the operative agency in September of that year.
Ten years ago, researchers showed that “from 1975-1999, only 1.3 percent of new drugs and medicines were developed for neglected tropical diseases and tuberculosis despite the fact that these diseases accounted for 12 percent of the global burden of disease”.
Yet, when adopting the eight MDGs in September 2000, WHO dismissed both neglected tropical diseases and TB. In Goal #6, the only one with a specific disease target, it read: “Combat HIV/AIDS, Malaria and other diseases”. The urgency now being expressed in the high burden of tropical diseases by the CEWG was curiously absent in 2000 when WHO relegated them to a global potpourri of ‘other diseases’.
Is the low percentage of new drugs and medicines as important a factor in subsequent access and affordability, or is the number of drugs that actually came on the market in this period to diminish tropical diseases more important? Let’s look at a few examples.
In 1978, an R&D company introduced Ivermectin to combat an age old scourge: onchocerciasis or river blindness. It made this therapy available at no cost into perpetuity. This disease is the world’s second leading cause of infectious blinding, leading to reduced agricultural output. A World Bank evaluation looked at riverine communities that had left the land due to endemic blindness. Once this disease “was controlled, 25 million hectares of land were returned to agricultural production, enough to feed 18 million people”.
In the 1980s, USAID sponsored a program to introduce Oral Hydration Salts (ORS) as the treatment of choice for diarrheal disease. The product was developed by an R&D company, and considered by some to be “possibly the most important advance of this century”.
Although the R&D companies patented their respective therapies, neither enforced them when other non-R&D companies massively produced these products. Today, ORS is the preferred treatment for diarrheal diseases, saving the lives of millions of poor children.
In 1987, when the global AIDS epidemic was beginning its ascendancy and no interventions were in sight, one R&D company developed the first therapy for effective treatment: AZT. This sparked a revolution in product innovation by others: today MSF records that there are 26 different therapeutic classes of ARVs, all of them covered by extant patents. Most are being produced by Indian firms as generics without fear of legal challenge from their right-holders. MSF has designated India as “pharmacy to the developing world”. (9) WHO records in 2012 more than 8 million AIDS patients under life-extending ARV treatment, up from less than 50,000 in 2003.
In 2006, the Congressional Budget Office published a study on average costs and times to successfully develop a new molecular entity. “In 2000, the total cost was $802 million, with an average time of 11.8 years to bring a product to market”. By 2012, that average costs has risen to $1.3 billion and the time to 12+ years.
All new drugs that reach the market after FDA approval don’t necessarily find a market. In 2006, one R&D company introduced a new inhaler for asthmatics. By 2011, it had to conclude there was no market for it, writing down $2.3 billion in losses. An R&D Convention would most certainly produce some losers; how would they be covered?
The first order of business for the CEWG should be: in a global health community increasingly focused on evidence-based programming, can the concept for an R&D Convention be sustained by its founding premises?
If these answers can provide confidence to continue with the concept, then advocates need to propose a new regulatory agency with extraterritorial enforcement authorities. It would have to address this question: is there a scientific justification for the retention of FDA/EMEA pharmaceutical quality requirements more stringent than those of the proposed R&D Convention? Investors, public and private, would want assurances of this nature before they expend untold billions in the absence of a proof of concept.
WHO inaugurated the concept of Health for All by the Year 2000 at Alma Ata, Russia in 1977. According to the Development Assistance Committee (DAC), during the period 1990-2000, donor contributions were: $23 billion in health; $7 billion in population & family planning; and $30 billion in water supply and sanitation. More money was spent in the interim period of 1977-1990 which would bring total estimated spending to $90 billion. These initiatives were launched by WHO in disregard of a large body of excellent research into the relationship between health, poverty, and growth in developing countries. This research shows that economic development is the main driver in improving health, and that pouring money into public health spending rarely solves the problem.
To show progress on the money spent, WHO expended another $2.5 million to produce a new report in 2001: Macroeconomics and Health: Investing in Health for Economic Development, under the direction of Prof. Jeffrey Sachs. The main text is entirely bereft of any references to Health for All. There is no mention of it even in the Appendix or Glossary. Nothing to inform the global health community of how money was spent.
The basic thrust of the 2001 report was a formulaic expression: pour money in and stir. By expanding coverage for essential health services to the world’s poor through scaling up resources, poverty would be reduced, economic development accelerated, and global security advanced. This “could save at least 8 million lives each year by the end of the decade”.
However, previous research has clearly shown that pouring money into health is not the answer. This research could have provided more balance to new initiatives, allowing a sense of imputed legitimacy to the propositions being advanced.
- In the World Bank’s Development Research Group’s Child Mortality and Public Spending on Health: How Much Does Money Matter, authors found that the major drivers on reductions on infant mortality are economic and educational: public health investments account for 5% of this decline;
- In Bulletin of the World Health Organization, the author wrote: “a 1997 examination of cross-national variation in child and infant mortality found that 95% of the differences could be explained by differences in income, income distribution, women’s education, ethnicity, and religion”;
- Furthermore, “public spending on health was statistically insignificant at conventional levels and total public spending explained less than one-tenth of 1 percent of the observed differences”. (for more details see here, here, and here)
None of these facts have deterred 110 civil society organizations in 40 countries from sending an open letter on November 2 to the World Bank, calling on it to advance Universal Health Coverage. They stated: “underlying all its demands—is that strong and equitable health systems are the key to achieving universal coverage”. The letter’s “first ask is for the Bank to help countries remove out-of-pocket fees”.
Within these two sentences the organizations managed to establish a principle of equity, then subordinate it with a demand that the Bank remove a country’s sovereign right to impose fees on health services. They are challenging the Bank’s new president, Dr. Jim Kim, to change its traditional role as a bank to one of an implementing institution.
The removal of out-of-pocket payments would likely bankrupt many private health care systems in the developing world. In the largest countries by population size, the private sector is the dominant provider of health as a percentage of total national expenditures. It is 70% in Bangladesh; 82% in Cambodia; 65% in China; 83% in the Democratic Republic of the Congo; 60% in Egypt; 77% in India; 67% in Indonesia; 64% in Kenya; 55% in Mexico; and others. In these countries, patients are exercising one of the most fundamental precepts of democracy: choice. Why should the World Bank be complicit in silencing their voices!
The civil society organizations advocating Universal Health Coverage cite the example of Sierra Leon, a failed state, as the exemplar. Here, the World Bank “played a helpful role, alongside other donors, in providing financial support to the country’s successful free care policy for pregnant women and children”!
Like Health for All, Universal Health Coverage requires that donors support the initiative with ever increasing resource flows. However, the donors are in deep debt trying to forestall a journey over the fiscal cliff in their own health care systems. If they were to remove out-of-pocket payments in Medicare and Medicaid, a financial chaos would result affecting 16% of the US economy alone, while roiling through the service sector with untoward macroeconomic consequences.
The failure of Health for All and the 2001 WHO report on economics and health reinforces the notion among skeptics that donors have a major influence on allocating resources to new program initiatives but only a limited ability to stay the course of their actions. Neither initiative has earned a footnote from the 110 civil society organizations that are now advancing the notion of Universal Health Coverage.
On September 19, the Center for Global Development (CGD) asked: One Year Later, What Happened to Noncommunicable Diseases (NCDs)? It cited the UN General Assembly Resolution of 2011 adopting a 13-page “political declaration” to address the prevention and control of non-communicable diseases worldwide. Yet, no measurable goals to reduce NCDs, such as targets to reduce global mortality, or increased access to medicines, were agreed upon until a year later at the 2012 World Health Assembly (WHA).
Earlier, it seemed NCDs were gaining traction. In the Center for Strategic & International Studies (CSIS) report, they positioned this emerging issue on the global health agenda in February 2011 by stating the need to focus and leverage existing assets. In April 2011, the First Global Ministerial on Healthy Lifestyles and Noncommunicable Diseases convened in Moscow to galvanize support and provide policy guidance for the forthcoming UN High-Level Meeting on NCDs in September 2011. Subsequently, WHO drafted the ‘Moscow Declaration’ placing itself at the global epicenter of NCD prevention and control.
More than a year has passed and the upward trajectory of action hasn’t been perceptible. The CGD looked at this stagnation and asked if was caused by the bad economic climate or lack of political attention? The answer is, neither. Rather, those advocating NCDs can be said to have based their assessments on the Columbus Effect: the donor community’s “discovery” of NCDs. Donors are giving attention to them as if NCDs are akin to a newly discovered continent. However, reliable sources identified their emergence decades ago, and developing countries themselves invest heavily in building and operating hospital systems to address them.
Since 1984, the World Bank has reported that developing countries were expending the majority of their national resources in hospital-based services, largely for patients above the age of 15 years with chronic conditions. Many of these facilities have earned the highly reputable Joint Commission International (JCI) which has accredited organizations in 39 countries and in over 300 public and private health care facilities. Most are in aid-assisted countries, e.g., 45 are in Turkey; 25 in Brazil; 17 in India. Others with more than 2 facilities are located in Bangladesh, China, Costa Rica, Ecuador, Egypt, Ethiopia, Indonesia, Jordan, South Korea, Lebanon, Malaysia, Mexico, Pakistan, the Philippines, Thailand, Viet Nam and Yemen.
Developing countries have also become health care attractions for citizens of donor countries. Medical tourism is a major multi-billion dollar industry in Malaysia, India,
Thailand–each one an aid-assisted country. The largest, the Apollo Hospitals, is based in India and it frequently collaborates with Johns Hopkins International. Medical tourism is the largest service sector with estimated revenue of $35 billion, constituting 5.2% of India’s GNP, and employing 4 million people. By the end of 2012, it is expected to grow at 15% per annum, with revenues of $78.6 billion, reaching 6.1% of GDP, and employing 9 million people.
While donors were pouring more resources into communicable diseases, they failed to notice that recipient countries were expending large portions of national health allocations in hospitals for chronic care. In 1984, the World Bank records that Malawi was spending 81% of its total public recurrent health expenditures on hospital care; it was 75% in Jordan; 74% in Lesotho; 73% in Kenya; 72% in Jamaica; 71% in the Philippines; 71% in Sri Lanka; 70% in Somalia; 68% in Brazil; 67% in Colombia; 54% in Zimbabwe. Of the hospital expenditures listed above for these countries, “all use at least 70% of their national health resources on adult and elderly patients”.
While developing countries have long been stepping up to the plate in combating these diseases, in contrast the WHO has recommended that the donor response to NCDs be limited to only four diseases: CVDs, cancer, diabetes, and upper respiratory diseases.
These limitations are contrary to the extant clinical standards of most developing countries which have Constitutional guarantees to open and free access on healthcare. Most importantly, they reflect donor priorities, attempting to force-fit them into those already taking place by the countries themselves. They represent the values of ‘discoverers’ ring-fencing their newly found possessions around indigenous institutions.
In the end hospitals will continue to absorb the largest share of national health expenditures, independently of anything the donor health community will do with its recent ‘discovery’ of these diseases. If WHO is successful in guiding donor support for NCDs, then it will have to post this notice in public hospitals:
If you have a CVD, cancer, diabetes, or an upper respiratory infection, with one of the four designated risk factors, welcome! Otherwise, please move on to one of our nation’s local hospitals which offer comprehensive NCD prevention, care and treatment.
Such a policy outcome from the WHO recommendations has no clear or fair rationale. It is unlikely to resonate with the professional medical societies in the developing world which, in most countries, are under the purview of ministries of higher education and provide clinical staffing for NCDs to their major hospitals. Perhaps NCDs would not have blown away, had collaborative strategies been discussed at first ‘discovery’ by donors.
A Workshop on counterfeit medicines promoted by the Global Forum on Law, Justice and Development (GFLID) and hosted by the World Bank was conducted on October 2-3, 2012. The objective was to use a knowledge-sharing workshop that would facilitate a multidisciplinary understanding of the “global phenomenon of Counterfeit Medicines”. GFLID’s goal was to facilitate relevant parties to convene and establish a “Community of Practice”.
Despite the recent media coverage on the alarming rise in counterfeit medicines, there is no reliable data on the real scale of this problem. During the workshop some estimates and studies were presented. For instance, it is estimated that 15% of the $1+ trillion in global sales in the developing world constitute a threat to patients. The situation is more dire in the poorest countries, where Interpol estimates that 30% of medicines circulating in Africa are either counterfeit or of inferior quality. A recent study by WHO on the quality of anti-malarial medicines in Sub-Saharan Africa revealed that 44% of samples from Senegal and 30% from Madagascar could “be qualified as of inferior quality”. A representative from the Council on Europe commented that the value of counterfeits came to $75 billion in 2011. However, no estimates were offered on substandard drugs.
While these estimates are important, the World Bank representative commented that there still is “no good data for the economic impacts of counterfeit drugs”. The USP representative, Patrick Lukulay, tried to address the economic impacts by explaining the major public health consequence that stem from drug resistance through the use of substandard drugs, which negate investments by donor agencies. Local manufacturers have a high barrier to overcome for investments in pharmaceutical capacity, because they face interest rates between 37-45% for access to capital.
Enforcement and tracking down the origins of counterfeits, is yet another obstacle in combating counterfeit drugs. The representative from the US Department of Trade credited this difficulty with the fact that 70-80% of the Active Pharmaceutical Ingredients (APIs) for global manufacturing is made in China and India. The WHO representative presented five reasons for this intricacy:
- lack of affordable medicines;
- lack of awareness in the healthcare work force;
- weak legislation and regulatory capacity;
- high corruption levels;
- and, a complex supply chain with greater Internet connectivity.
Despite the prevalence in discussing the complexities and difficulties faced, solutions were presented as well. Michele Forzley, a representative from Georgetown University’s law school, submitted a recommendation to have WHO add a new code to the International Classification of Diseases (ICD), which already has code for “injuries” that are unintentional (traffic accidents) and intentional (self-inflicted). A new code for harm caused by the use of counterfeit/substandard drugs could, for example, list the number of hospital beds being filled by patients with adverse reactions to counterfeits.
The representative from the Council of Europe discussed its formation of a unit called Medicrime. It is not intended for the protection of intellectual property; rather the unit is to protect victims from unscrupulous manufacturers of counterfeit drugs. If a false claim by a manufacturer is made, that is a crime. If the manufacturer by-passes regulatory authorities, then this is what Medicrime prosecutes. It criminalizes the illegal trade of counterfeits.
The USAID representative presented a paper on the various programs his agency has set in place to improve the quality of drugs in circulation by working closely with USP and the FDA to build competent regulatory authority capacity in the developing world. Murray Lumpkin and Lliza Bernstein discussed the new tools the Congress has given the FDA to ‘go global’ with its capacities to ensure the quality of medicines for patients’ use. This will permit the FDA to work more collaboratively with USP, USAID, Interpol, etc.
Overall, an important trend was outlined. In a 2005 Workshop on counterfeit medicines, the World Bank’s director of its health office commented that $30 billion was spent on fake drugs in the same year that only $8 billion was expended on legitimate health expenses. The upward trend is disturbing, especially when the University of Washington estimates 2010 donor financing for health aid at $26.9 billion; almost enough to cover the amount spent in 2005 on counterfeit medicines.
While this Workshop brought together key actors from the public and private sectors, one entity was missing in action: ministers of finance. Almost all pharmaceutical procurements require expenditures of scare foreign exchange which ministers of finance control. Most counterfeits escape custom duties and taxes. Thus, not only are they losing these revenues, but they are procuring worthless products. They bring in huge indirect macroeconomic consequences of lower workforce productivity, early retirements, and disabilities when patients are harmed, incurring future unfunded liabilities.
In content and context, the Workshop was a contemporary reprise of another situation which captured the world’s attention: Houston, We Have a Problem! The global threat of counterfeits surely merits global, regional and national solutions through the establishment of a Community of Practice on this topic. In its absence, all the good that is being done can be undone.
The World Bank, WHO, and just about everyone else measure national health expenditures against Gross National Product (GDP) in the sure and certain knowledge that the metrics are an apples to apples comparison between nations. Within a one week period, two different Washington Post columnists wrote similar columns, using national health expenditures as a percentage of GDP. One claimed that “ Other industrialized countries provide universal health coverage for their entire populations for a fraction of what we spend in the United States, and those other countries achieve equal or better health outcomes”. The other commented: “the United States spends twice per person on health care what most other advanced nations spend without better outcomes to show for it”. However, in neither case did the columnist provide any examples of health outcomes relative to GDP on health expenditures. The ‘outcomes’ were limited to the readers’ imagination.
While GDP is the sum total of all goods and services within one sector of an economy, when measuring it against health expenditures in pluralistic sectors like the U. S., can it yield the same measurement as in a universal sector, such as England and Canada’s national health services, or France’s national health insurance system?
One of the most commonly used outcomes is infant mortality rates, in which the U.S. consistently ranks lower than many other developed countries. This rate is heavily influence by difficult to control social and cultural factors which dampen the effects of health inputs. A significant portion of the infant mortality rate in the U. S. is due to a lack of pre-natal care for immigrant and teen-aged mothers. The former have a tendency to wait until they can access emergency room services, and the later—usually because of stigmas, forestall medical attention until the last moment when delivery is evident.
What is the difficulty in relating outcomes to expenditures between countries? For instance, the US is the only country in the world with a mandatory Mal-practice Insurance System. Approximately 52% of the health system expenditures are in the private sector where accelerated depreciation of plant and equipment is a standard tax deductible business expense, as are capital investments. Contributions from employers and employees 401 (k) and other retirement plans are included, as are payroll contributions to Medicare, Workmen’s Compensation, and Social Security. Lastly, millions of foreign patients come to the US annually for health services that are available free of charge in their home countries—if they were willing to stand in line. Those expenditures are added to the US GDP and deducted from the GDP of their universal systems.
In universal systems, such as in England and Canada, the GDP expenditures are based on the annual health budgets appropriated by their respective governing bodies. They have to tailor service delivery to specific budget allocation, a system that often leads to rationing in order to meet pre-established fiscal targets. Since they are universal systems financed directly from general tax revenues, there is no need to charge tax deductible expense items, such as plant and equipment, or finance Mal-practice insurance, or to provide pension benefits which fall under entirely different components of England and Canada’s comprehensive national budgets.
There are also more subtle pricing anomalies on goods and services which mask total expenditures between countries. On medicines, England operates a system of profit regulation that constrain prices to yield no more than a target overall rate or return on capital. The Canadian government monitors price levels at launch and rates of increase to assure that they are ‘reasonable’. Japan, Denmark and France subsidize the R&D components of their pharmaceutical and vaccine industries. When price per gram of active ingredients in a pharmaceutical product are compared, Japan and Switzerland are more expensive than the U. S. And Germany, the Netherlands, Denmark and New Zealand operate reference price systems on reimbursement and thereby exert strong pressure on prices charged by manufacturers.
Another subtlety is the hidden subsidies between the U. S. and other developed countries, as can be seen in France’s national health insurance system. France decides which drugs to use and at what prices; American pharmaceutical companies must either accept the dictated prices or lose enormous market. The companies therefore sell their medicines in the U. S. in order to cover their expenses and turn a profit; the surplus is then sold cheaply to the French, who take the same pills as Americans but at half the price or less.
If one were to deduct from the U. S. health expenditures those items that are not in the GDP of universal systems, how far would its current 17% of GDP—15%? fall and close in on those lower percentages in other developed countries!
When lamenting the U. S. expenditures of 15% of GDP on health, one would think that the money is going into some black hole in space and has no redeeming value to society.
In major U. S. cities, like Houston, San Francisco, Seattle, Boston, Rochester, Pittsburg, Cleveland, and New York, the health sector is within the top three levels of contributions to their GDPs. It accounts for the highest rate of new union workers. And in an economy which desperately needs to create more jobs, the health sector has delivered its fair share.
For all these reasons, using the current metrics on where a nation stands relative to any other nation is an imperfect tool for policy prescriptions in the health sector. If they tell us anything when we peel back its layers, it is that they are an apple to brick comparison.
On March 10, 2005, the World Bank conducted a workshop entitled: “Good Intentions—Bad Drugs”. The keynote speaker from the Bank commented, using WHO data: “in 2004, approximately $30 billion was expended on fake drugs in the same countries where legitimate health expenditures were only $8 billion”.
The WHO reports that an estimated 10% of the global market (valued at over $1 trillion) for medicines is counterfeit. In developing countries the problem is larger, estimated as high as 25-50%. Another WHO study estimated that 30% of drugs sold in Africa were substandard. In still another study within five African countries and India, 41-47% of drugs sampled did not meet all quality standards.
According to WHO, counterfeit drugs are deliberately and fraudulent mislabeled with respect to identity and source. They are produced by criminals.
Substandard drugs are genuine drugs produced by legitimate manufacturers that do not meet the recognized quality and purity standards used by that manufacturer or by the regulatory authorities. By definition, then, copy drugs are substandard drugs.
The problem of counterfeit/substandard medicines has been seething for some time, bringing in their wake an accelerated onset of drug resistance. In 2004, WHO had to de-list 36 ARVs that it had previously placed on its Prequalification Programme. All had been produced in India and were substandard drugs, aka as copy drugs, rather than generics. WHO announced in a public statement that the de-listings were due “to a lack of proof of bioequivalency”. However, WHO did not require its Members to recall the drugs or to conduct a post-marketing surveillance, a requirement of stringent regulatory authorities.
In 2007, the Global Fund to Fight HIV/AIDS, TB and Malaria had a Three Option procurement policy. Option C included drugs that were not approved by a regulatory authority even when there is an approved, prequalified alternative. In that year, the Fund documented that of 2,254 single procurements by its recipients, “half were found to be non-compliant with its QA policy and one-fifth were purchased using Option C. The Fund was notified in only 2 of 426 cases.”
WHO was supposed to have guaranteed that such procurements were from countries thathad earned a GMP Certification from the Organization. This is a manufacturing standard rather than a product standard attesting to its quality, safety and efficacy. Other UN-affiliated entities, such as UNITAID and the Clinton Foundation, used Option C also.
On July 1, 2009, the Global Fund approved a revised Quality Assurance Policy for Pharmaceutical Products. It has two options: 1) Prequalified by WHO or authorized for use by a Stringent Drug Regulatory Authority; 2) Recommended for use by an Expert Review Panel (ERP). Subsequently, WHO was designated as the ERP. WHO’s basic requirement for procurement under the second is GMP—a Certification that it issues to Member States. Of the two Options, then, only part of the first relies on standards recognized by stringent regulatory authorities, such as the FDA and EMEA. Yet, the Fund equates WHO, a Membership Organization, in Option 1 with those same authorities. In all editions of its Prequalification Programme, WHO issues a Disclaimer: “not warranted for safety and or efficacy if used in the treatment of HIV/AIDS.”
The Center for Global Development (CGD) published a landmark study on drug resistance in 2010.
- Regrettably, the practices of those who are seeking to expand access can unintentionally accelerate the spread of resistance by making drugs widely available where conditions for assuring quality and appropriate use are weak;
- the opportunity costs of treating resistant diseases are considerable. For instance, it costs as much to cure one patient of extensively drug-resistant XDR-TB as it does to cure 200 patients of susceptible TB;
- for every person put on 2nd line ARV treatment due to drug resistance, far fewer people can then be given access to life-saving or life-extending care;
- about 22% of AIDS patients switch to 2nd line therapy after about 20 months on a lst line therapy;
- and, health care experts expect that high mutation rates of the virus mean that eventually all those on ART will acquire resistance to the drugs they take.
On July 13, 2012, The Washington Post printed an article in its editorial page on unsafe drugs. It commented that “some drugs that the World Health Organization has approved for distribution to the world’s poor are of inferior quality—and some of the manufacturers, predominantly Chinese and Indian firms, may be knowingly producing them. … Sometimes a fifth of them failed basic quality-control tests”. Although WHO has launched an investigation into product failures, “it lacks the resources to do much more”.
On August 5, 2012, perhaps in response to the global publicity from The Washington Post article, China arrested 2,000 people, and destroyed 1,100 production facilities as part of a nationwide crackdown on counterfeit drugs.
When the CGD article was published in 2010, there were fewer than 4 million patients under ARV treatment. Today, that number has increased to 8+ million. That report went on to comment: “unfortunately, the global health discourse about extending use of ARVs focuses almost exclusively on treatment targets, neglecting the reality that as more drugs are used, more resistance will be selected for”.
The CEO of U. S. Pharmacopeia publicly warned: “there are likely to be few faster ways to induce resistance to current AIDS drugs than by treating patients with substandard products”.
As treatment targets continue to increase towards universal coverage for HIV/AIDS, TB and malaria patients, it can be expected that counterfeit/substandard drug use will follow suit. And in train, drug resistance will rise globally, imposing substantial health and economic consequences. During the World Bank seminar in 2005, the Director of its health office commented: “much of the good being done is rapidly being un-done by unscrupulous counterfeiters whose only objective is profit at the expense of the poor”.
What can be done! WHO can undertake a major corrective step in this regard by recognizing its limits as a Membership Organization and refrain from approving drugs, then issuing Disclaimers—which are unknown to patients. It made such a correction in 2004 after de-listing 36 ARV copy products and then partnering with the US FDA on ARV therapies in its Prequalification Programme. Today, almost all of its listed ARV products now carry a FDA certification as true generics. WHO can expand its considerable moral powers with other stringent regulatory authorities, such as the EMEA, for other therapies and thus ensure that poor patients in the developing world receive access to drugs of known quality, safety and efficacy—without a Disclaimer.
Now that WHO is supporting a new global program to include access to medicines for chronic diseases, this corrective step is an imperative!