Two studies indicate that daily prophylactic use of antiretroviral therapies may be an important addition to an overall anti-infection strategy for uninfected individuals who engage in sexual activity with HIV-infected partners. In mid-July, the Centers for Disease Control and Prevention released results of a study (referred to as the TDF2 study) done in Botswana, along with a separate trial by the University of Washington conducted in Kenya and Uganda, that show “a daily oral dose of antiretroviral drugs used to treat HIV infection can reduce HIV acquisition among uninfected individuals exposed to the virus through heterosexual sex.” In this study, uninfected individuals taking pre-exposure prophylaxis (PrEP) reduced their risk of acquiring HIV infection by roughly 63 percent overall.

A previous study, says the CDC release, demonstrated that PrEP can reduce the transmission of HIV among men who have sex with men as well.

The CDC release cautioned that the prophylactic therapy “was only shown to be effective in clinical trials when provided in combination with regular HIV testing, condoms, and other proven prevention methods.” The release contained other important conditions and caveats.

When administered properly, this type of preventive, or pre-exposure prophylaxis, treatment has amazing promise, especially for populations in sub-Saharan Africa countries, where two-thirds of the world’s HIV infected individuals (a total of nearly 34 million people are HIV-infected) reside, according to World Health Organization and UNAIDS statistics.

Another report, published in this week’s Annals of Internal Medicine, shows that life expectancy of patients living in Uganda “increased substantially” with the use of combination antiretroviral therapy, again giving hope to already infected HIV patients that they may be able to live a long, normal life.

This time last year, President Obama initiated a National HIV/AIDS Strategy that aims to reduce the number of new HIV infections, increase access to care and improve health outcomes for people living with HIV, and reduce HIV-related health disparities. Since then, investments [e.g., funding for the AIDS Drug Assistance Program in FY 2011 was increased by $50 million and funding for HIV prevention programs at CDC were increased] and related policy changes have been made. But to continue making progress and to meet the strategy’s upcoming year of goals, which largely focus on increasing collaboration and partnerships, the government needs to maintain its commitment to HIV/AIDS prevention and treatment.

The debt ceiling debate that has plagued the news wires recently is not just about the US government’s ability to pay back its loans or about America’s reputation around the world (although those are highly important factors), but it also affects many programs, including healthcare and ultimately HIV/AIDS prevention and treatment. Potential cuts to the Medicaid program as part of a debt-relief deal could have a significant negative effect on the National HIV/AIDS Strategy and its related goals, reports David Ernesto Munar of the Huffington Post.

This week, the sixth annual International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention is taking place in Rome. On July 19, data released at the conference showed that global investments in HIV treatment-related research and development reached $2.46 billion in 2009, with the US National Institutes of Health providing the most public-sector investment at $1.6 billion [www.treatmentactiongroup.org.] In the same year, bio/pharmaceutical companies invested $591 million. According to a UNAIDS press release about the report, an estimated 6.6 million people currently have access to antiretroviral treatment but 9 million more are still in need.

UN member states committed to expanding access to treatment for 15 million people by 2015. And Goal 6 of the UN Millennium Development Goals, which the US and all UN member states have agreed to work to achieve by 2015, calls for universal access to treatment for HIV/AIDS and for the reversal of the spread of HIV/AIDS.

The scientific community is doing its part to make breakthroughs in HIV prevention and treatment that could not be conceived of even 5 years ago. It’s only fair that US leaders continue to do their part as well.

A few common themes came out of the discussion including a focus on innovation and collaboration. And session moderator David Campbell of IMS Health—a key analyst in IMS’ list of “pharmerging markets”–pointed out that despite any differences among national global health and manufacturing strategies, it is clear that every nation desires healthcare for all.

Individually, Argentina’s Baranao noted that his government will be investing a lot more in healthcare and diagnostics during the next three to five years. He suggested that one of Argentina’s strengths is its regional market power and noted that other countries may want to start looking at regions versus countries for future R&D, trade, and so forth. He also noted that Argentina’s aging population will provide opportunity for healthcare and bio/pharma, and that Argentina’s ethnic similarities to Europeans should be considered in future drug discovery and R&D trials.

Brazil’s Ramundo said that his country—one of the BRIC nations and a growing leader in pharma manufacturing—intends to continue to grow. Its northern region, in fact, is growing at the same pace as most of China.  Brazil’s government plans to  move 16 million people out of poverty and into the healthcare system over the next 10 years, a move that will provide great opportunity—as well as challenges—for the healthcare and drug sectors. He noted that pricing and segmentation will be of interest. He also pointed out that Brazil’s current regulatory system, stable budget, and healthcare policies are likely to  help the country in these endeavors.

India’s Mohan said that his country has had a strong biotech strategy for several years and will be taking a more international approach in the next few years. Part of its near-term strategy will involve looking into biosimilars as an area of growth. India’s population is growing quickly and opportunities for healthcare and pharmaceuticals will grow with it, he noted.

South Africa’s Gumede pointed out that South Africa, as a port and trade starting point, is the gateway to many African countries and that nations elsewhere should consider this as they strategize to enter the African market. He noted the advantages of the new trade bloc getting underway throughout most of the entire African continent that will bring together the existing Common Market for Eastern and Southern Africa (COMESA), the East African Community (EAC), and the Southern African Development Community (SADC).

Burrill provided a few predictions of his own for the future of the biotech, pharma, and global healthcare sectors. He noted that “cellphonology” will be of particular interest as cell phones are used more and more as diagnostic tools, and that the world will need to think of how healthcare is managed and delivered in a whole new way. As an example of how much things may change in the next 10 years, he pointed out that Google is less than 10 years old and that this single technology has changed forever the way people work and interact. Similar developments and technologies that we cannot even envision are likely to come at a rapid pace in the near future, he said. As new diagnostics, treatments, and cures are discovered, he noted that the future of healthcare may very well be less about treating sick populations and more about keeping healthy populations well. In other words, healthcare targets will be less about acute care and more about chronic care and prevention, he said. This is especially true as noncommunicable chronic diseases such as diabetes, hypertension, and cancer grow in developing nations like China.

Looking further ahead, Burrill noted that the big pharma companies of today are likely to be replaced  by companies that are just starting—or will soon be established—in the emerging markets of the world. He went on to say that the Internet and connect-ability will change the nature of competition and that new capital structures to build different kinds of companies and countries will exist. He also asked the audience to keep in mind two growing powers: consumerism and brand value. These powers will be of surprising importance in the future according to Burrill.

Finally, the growing occurrence of South-South trade (i.e., trade between nations in the southern hemisphere, such as India and Brazil) will need to be considered as North American and European countries and companies plan their market strategies.

Indeed, many of this week’s price cuts have been made in response to a tender off for the rotavirus vaccine (the world’s second largest killer of children after pneumonia) from the United Nations Children’s Fund (UNICEF), which supplies medicines to children in developing countries. The reductions were detailed in a statement from the GAVI Alliance, a global health partnership that aims to increase access to immunisation programmes in poor countries.

GlaxoSmithKline (GSK) has come forward with an offer of just $2.50 per dose or $5 to fully immunise a child, which is a 67% reduction on the current, lowest available public price. However, GSK isn’t the only company  taking an axe to its prices. Merck has said it will offer its own rotavirus vaccine to UNICEF at a discounted price, and new market entrants in India, including Bharat Biotech, the Serum Institute and Shantha Biotechnics (a subsidiary of Sanofi Pasteur), are also developing rotavirus vaccines for GAVI-eligible countries, although these are not expected to be ready for purchase until 2015. However, these vaccines could encourage further price reductions. On its website, Bharat Biotech has said that it will offer $1 per dose.

According to Helen Evans, GAVI’s interim CEO, if the rotavirus vaccine could be purchased this year at a $2.50 price, the impact on public health could be significant. It would also enable GAVI to save approximately $500 million through to 2020, or about $140 million through to 2015, as measured against GAVI’s current financial estimates.

Cuts have also been made to the prices of other important vaccinations. For instance, the Serum Institute and Panacea Biotec (India) have both lowered the prices of their pentavalent vaccines. GAVI’s statement added, “The price reductions illustrate the key role of emerging market suppliers as new global players, contributing to both innovation and increasing competitiveness in the market place.”

Merck has also offered its human papillomavirus (HPV) vaccine at a reduced price of $5 per dose, while Crucell and Sanofi Pasteur have announced that they will extend GAVI prices on their pentavalent vaccines to the 16 countries expected to graduate from GAVI support. In its statement, GAVI added that these announcements build on similar commitments made to graduating countries by Pfizer and GSK.

“Our market-shaping goal is to achieve the lowest price for currently available products while maintaining supply security,” said Evans. “Looking forward, Alliance members will work to broaden competition and ensure the provision of quality vaccines at sustainable prices. Today’s announcements are a step forward to achieving this goal.”

GAVI’s statement was issued in the lead up to its first pledging conference, which will take place next week.

Although the actual numbers are still under debate, the fact is that there are more refugees today that have been forced to leave their homes because of changes to their climate and environment than those fleeing war zones. Whether one believes in global warming or not, the facts demonstrate that the Earth is changing. Certain locations in sub-Saharan Africa, for example, that used to rely on annual rainfalls for their crops and livelihoods have been left without significant rainfall for months if not years.  As a result, they have had to leave their homes for wetter lands just to survive. In many cases, residents of these areas have  had to move into more populated, suburban or urban areas.

I’ll leave it to the environmentalists and policymakers to discuss these issues in more detail, but there is a point here relevant to the pharmaceutical industry. With migration and the growth of environmental refugees comes the spread of disease, especially infectious diseases such as malaria, tuberculosis, and HIV/AIDS. Climate change can aggravate infectious diseases by increasing the temperatures under which many diseases and their carriers flourish, by stressing and altering habitats, and by causing migrations, according to the UN Environmental Program. Populations entering new areas may also be more susceptible to already existing diseases in that environment.

Many pharma companies are working at the local level to address disease prevention and treatments in these affected locations, which PharmTech reports on through a column devoted to the industry’s role in global healthcare efforts.

Earth Day is great for raising awareness of these issues. But the resolution of these problems depends on our attending to these global health challenges daily. While pharmaceutical companies may not be able to stop the world’s ecosystems from crumbling, they can make an impact by reducing their carbon footprint and by continuing in their efforts to improve access to healthcare education and treatment to the populations that need it most.

The summit brought together leaders from business, government, and nonprofit organizations as well as individuals that are on the front lines in villages and communities around the world. They shared their perspectives and experience in working on specific projects to bring about increased access to healthcare and education, business development, and individual economic advancement. While attending the summit, I was impressed by industry efforts to provide support in tackling larger global concerns, not only in cash and product donations, but also by using collaborative service models. In these collaborations, companies offer their expertise in technical support, business management, supply-chain management, marketing, and other areas to support social entrepreneurs, small- or medium-sized business, or other organizations to create sustainable models that contribute to economic and social progress. A report of the summit can be found in the April issue of Pharmaceutical Technology’s Sourcing and Management as part of our coverage of corporate citizenship and sustainability.

The importance of this work was underscored by the panelists at the summit, which included leaders from government, business, and nonprofit organizations. Speaking at the summit were: former US President and head of the William J Clinton Foundation, Bill Clinton; US Secretary of State, Hillary Rodman Clinton; former US Secretary of States Madeline Albright and Condoleezza Rice; Ambassador at Large for Global Women’s Issues at the US State Department, Melanne Verveer; former Chilean president and now Under-Secretary General and Executive Director of UN Women, Michelle Bachelet; and Ngozi Okonjo-Iweala, managing director of the World Bank.

Business leaders from technology, financial, media, and consumer sectors also participated. They included: Pam Darwin, vice-president of geoscience at ExxonMobil Production Company; Sheryl Sandberg, COO of Facebook; Susan Sobbott, president of American Express OPEN; Gabi Zedlmayer, vice-president of global social innovation at Hewlett-Packard; Diane von Furstenberg, chairman and CEO of Diane von Furstenberg Studio LP; Dina Habib Powell, president of the Goldman Sachs Foundation and managing director and global head of corporate engagement; and John Donahoe, president and CEO of eBay. Representatives from philanthropic and humanitarian groups also spoke, including Melinda Gates, co-chair of the Bill & Melinda Gates Foundation; Judith Rodin, president of the Rockefeller Foundation; and Katy Bushkin Calvin, CEO of the United Nations Foundation.

The summit provided panelists and attendees an opportunity to gain an understanding not only of the specific challenges in advancing economic and social development, but also more importantly, of the solutions that are being taken individually and collectively. The insight that was the most valuable was from the women from the front lines in the developing world who are directly engaged in projects to improve the quality of life for those around them. In highlighting just a few of the panelists, Hawa Abdi, MD, founder of the Dr. Hawa Abdi Foundation and HA Village in Somalia, discussed how she founded and now heads a hospital and community in Somalia where more than 90,000 Somalis, many of them refugees, receive food and medical care. Amy G. Lehman MD, MBA, founder and executive director of the Lake Tanganyika Floating Health Clinic, discussed her efforts in addressing the problem of healthcare access for isolated communities in the Great Lakes region of Central Africa. Eva Walusimbi, an entrepreneur at Solar Sister, an ExxonMobil partner and social enterprise, spoke of her work in selling solar lights in Uganda and her work in training and recruiting female entrepreneurs for building solar businesses in that country.

In listening to their stories, I was struck not only be the powerful reports of their work, but I also gained a better understanding from these first-hand accounts of the importance of building the connections necessary to produce solutions, and perhaps more significantly, of the shared value that our individual and collective participation can create. Secretary of State Clinton perhaps summed it up best in her keynote address at the summit. In speaking of the work of Dr. Hawa Abdi, she said, “When you looked at the smile on her face, you know that it is a life well led, a life in the service of others.”

Ghana
Regulators in Ghana last week found that substandard and counterfeit versions of 13 antimalarial drugs were in use in sites across the nation. The discovery of the fake medicines was made possible by the Medicines Quality Monitoring surveillance program, which is a collaboration between the Ghana Food and Drugs Board (FDB), the US Pharmacopeial Convention (USP), and the US Agency for International Development (USAID). The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative, which aims to improve the drug quality in developing countries.

A recall of the antimalarial drugs was initiated, and the names of the outlets where the drugs were uncovered were publicized. According to a USP press statement, the release of those locations was “intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers.”

Patrick Lukulay, director of the PQM program, said, “It’s important to keep in mind that all these fake and substandard medicines were found just in one round of postmarket surveillance, just of antimalarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations.”

Liberia
Liberia established a new regulatory authority to oversee the country’s medicines by signing into law the Liberia Medicines and Health Products Regulatory Authority (LMHRA) Act earlier this month. The legislation addresses the growing problem of substandard and counterfeit drugs in the nation’s market, according to a USP press release. USP’s PQM found that postmarketing sampling and testing that the organization conducted in March 2010 revealed a failure rate of 44% when 104 of 234 samples tested failed either simple disintegration, thin-layer chromatography, or both.

“We celebrate this important milestone in the history of the pharmaceutical sector of our country,” Reverend Tijli Tarty Tyee, Sr., chief pharmacist of the Republic of Liberia, said in the press release. “We believe that the implementation [of this Act] will be the most important aspect of the law that can ensure the protection of the citizens within our borders.”

Zambia
A pharmacist in Zambia called on the government last week to empower regulators to help fight the spread of counterfeit drugs. According to an article in the Zambia Post, Christopher Sakala said in a presentation during the Stop Stockout Campaign anticounterfeiting seminar in Lusaka that the country’s Pharmaceutical Regulatory Authority needs more inspectors, saying that five for the entire country conducting inspections at two entry points is simply not enough.

“The Pharmaceutical Regulatory Agency needs to be equipped properly. It is a professional body that works very hard to check on the quality of medicines the Zambian patients consume. This is a body that is serious with issues of public health, but they work under difficult conditions,” Sakala said.

He also advised health institutions to employ licensed pharmacists to distinguish between legitimate and counterfeit drugs.

See related PharmTech articles:

USP and USAID Launch New Program to Improve Drug Quality

Sproxil’s Mobile-Phone Technology Tracks Medical and Food Donations, Prevents Diversion

An International Web May Trap Pharma Counterfeiters, but It Won’t Keep Them for Long

When Substandard Drugs and Developing Nations Collide

The trial will study a combination of two vaccine candidates, Ad26.ENVA.01 (manufactured by Crucell) and Ad35-ENV (developed by IAVI), in healthy adults who do not have HIV. The trial will focus on the vaccines’ safety and effectiveness as a prime-boost regimen. The goal of a prime-boost combination is that one vaccine is administered to prime the immune system and elicit a certain immune response before a second, or booster, dose is given to enhance the overall immune response.

A previous clinical trial based on a prime-boost combination took place in Thailand and represents the first time an AIDS vaccine showed promise in reducing the risk of infection. Results released in September 2009 showed that the combination of vaccines lowered the risk of acquiring HIV by roughly 30%. Additional data were presented at the AIDS Vaccine 2009 Conference and published in the New England Journal of Medicine. The research team wrote that, “Although the results show only a modest benefit, they offer insight for future research.”

Also announced this week was that the International AIDS Vaccine Initiative (IAVI) appointed Michael Caulfield executive director of the IAVI AIDS Vaccine Design and Development Laboratory (DDL). Caulfield previously held research positions at Merck (Whitehouse Station, NJ) and the Cleveland Clinic. As leader of the DDL, he will be responsible for IAVI’s translational research and vaccine discovery, as well as for expanding its R&D team.

“Mike’s joining at a critical time for the field,” said Wayne Koff, IAVI’s chief scientific officer, in a press release. “We’re in the middle of a renaissance in AIDS vaccine design and development.”

In related news, scientists at the National Institutes of Health (NIH) announced the discovery of two human antibodies that can stop more than 90% of HIV strains from infecting human cells in the laboratory. The team, part of the Vaccine Research Center, a division of the National Institute of Allergy and Infectious Diseases at NIH, also demonstrated how one of the antibodies does this. The scientists said the antibodies could be used to design improved HIV vaccines, or could be further developed to prevent or treat HIV infection, according to the group’s press release. The work was published in Science in two articles, found here and here.

The NIH team’s discovery plus the results of the Thailand vaccine trial are examples of exciting progress in the field of AIDS vaccine research. Many are hopeful that the Crucell clinical trial will add to the upswing of encouraging results.

See previous posts on this topic:

The AIDS Vaccine Challenge

Roche Ends HIV Research Program

Vaccine Makers Prepare for Challenges Old and New

In light of the changing global public health landscape, I think the UN should consider revising the MDGs before 2015, or at least devising a new set of health-based goals when the time comes.

Why change them? For one, despite being two-thirds of the way toward the 2015 deadline, many of the goals are nowhere close to being met. For example, the latest progress report on the UN website shows that, as of mid-2009, half of the indicators for improving child health (Goal 4) are either not on track to be achieved by 2015 or are actually deteriorating; the same is true for more than half of the indicators for Goals 5 and 6.

But another compelling reason to revise the MDGs has to do with a study published earlier this month inPLoS Medicine. The researchers argue that more cohort studies (including clinical trials, surveillance, and epidemiology) need to be done in sub-Saharan Africa on noncommunicable diseases (NCDs). They base their argument on research showing that NCDs such as cardiovascular, mental illness, cancer, and diabetes are now major sources of morbidity and mortality in the region. For example, the authors report that 23% of 1500 rural villagers over age five in Tanzania, Malawi, and Rwanda had hypertension associated with diet. The fact that individuals in developing countries are gaining access to more traditional Western foods and medicines, and assuming more “Western” life styles means they are also more prone to getting the same conditions and diseases that people in industrialized countries get.

Since the emergence of HIV/AIDS, health goals and groups addressing the lower African continent have focused on that disease and other communicable diseases such as malaria and tuberculosis. But, summarizes the PLoSstudy, NCDs are likely to overtake infectious diseases by the year 2030 and sub-Saharan Africa leaders do not have adequate resources to address these new health challenges. The study authors call for global health funders to take notice. The UN should also take notice.

This September, UN leaders will discuss MDG progress as part of a special summit. An agenda outline for the summit was released earlier this month (the full proposal is still being written) highlights ways to try to reach the goals by 2015 such as strengthening national ownership of the goals and mobilizing additional financing (a tall task in the current economic environment), but it does not appear that UN leaders are going to consider re-examining the actual MDG targets.

When the year 2015 comes, it will be a shame if the MDGs are not met, but it will be even more troubling if global leaders overlook NCDs and the new health challenges posed by NCDs in the developing world.

“Without good quality, safe medicines to treat diseases such as HIV/AIDS, malaria and tuberculosis, the impact of other health initiatives may be weakened. The PQM program focuses on this critical aspect of combating these diseases,” Gloria Steele, USAID acting assistant administrator for global health, said in a press release.

“The lives of patients are put in serious jeopardy when they take substandard or counterfeit drugs,” Roger L. Williams, MD, chief executive officer of USP, said in a press release. “Such ‘medicines’ have health as well as economic implications. Moreover, substandard medicines contribute to the development of drug-resistant strains of infectious diseases. Such strains are a leading challenge in the fight against malaria, HIV/AIDS and tuberculosis.”

The PQM program is an expansion of a previous collaborative effort between the two organizations called the Drug Quality and Information (DQI) program. Like the DQI program, PQM will be managed by Patrick Lukulay, PhD, director of drug quality and information at USP, who will work with USAID’s Office of Health, Infectious Diseases, and Nutrition, under the direction of Anthony Boni.

Lukulay told Pharmaceutical Technology that the goals of the PQM program are to build capacity in developing countries to improve quality of pharmaceuticals and quality-control testing, to raise awareness of the importance of drug quality and advise people on how to safely buy medicines, and to conduct research in developing countries on the quality of drugs available on the market.

Lukulay also discussed some future projects of the program, such as the upcoming publication of the results of a study about the quality of malaria drugs in Sub-Saharan Africa and the development of a program that would provide reference material at a reduced cost to African countries to aid in quality testing. PQM is also working on the development and promotion of technology to detect counterfeit drugs using hand-held spectroscopic devices, which provide a nondestructive method of finding fake drugs that is significantly faster than traditional wet-chemistry methods. He also discussed the group’s work in creating adverse-drug-reaction data sheets for use in developing countries and PQM’s efforts to gather pharmacovigilance data.

“We are excited about PQM because it is going to give us the opportunity to expand on the work we started over the past decade,” Lukulay said. Some examples of DQI initiatives include the establishment of large-scale continuous monitoring program for quality in Latin America, Africa, and Asia, which led to the seizure of counterfeit versions of the antimalaria drug Coartem (Novartis) from pharmacies in Ghana in July 2009; increasing the capacity of quality control and testing systems in Asia after finding a significant amount of substandard drugs in the Greater Mekong Subregion in 2003; and helping the Global Drug Facility to increase the availability of good quality second-line anti-tuberculosis medicines at affordable prices. Through the DQI’s work in Latin America, Africa, and Asia, he said they are “starting to see an impact.” The new PQI program will allow work to expand into Eastern Europe as well.

“This program allows us to finish the job we have started,” Lukulay said.

One of the International Criminal Police Organization’s (Interpol) six priority crime research areas is drugs and criminal organizations. As reported in the New York Times on July 20, the organization is working with an informal group of researchers and government officials in Africa, Asia, and the US to track counterfeit drugs that claim to treat malaria, a disease that takes nearly 1 million lives a year. The counterfeiting of pharmaceuticals in developing countries has become rampant, as noted in my blog post last week. In 2008, the UN Office on Drugs and Crime (UNODC) estimated that more than 25 percent of medicines consumed in developing countries are counterfeit. And just today, the US Pharmacopeia (USP) issued a release that counterfeit drugs claiming to treat malaria are being removed from the Ghana market after a citizen notified the Medicines Quality Monitoring program. The monitoring program was set up by the US Agency for International Development (USAID)-supported Drug Quality and Information Program and implemented by USP.

The trend of faking pharmaceuticals is growing because of the vast amounts of money counterfeiters can make. Take this example from Martin Van Trieste, interim director of Rx-360, the new international pharmaceutical supply chain consortium: If a counterfeiter invests $2000 in faking a DVD, he may turn that into $20,000; if he invests $2000 into faking cocaine, he may turn that into $200,000; but if he invests $2000 into faking a pharmaceutical drug, he may turn that money into $2 million! At the same time, the punishment for getting caught counterfeiting pharmaceuticals is far less severe than for counterfeiting illegal recreational drugs such as cocaine, says the NYT article.

According to the Federal Food, Drug & Cosmetic Act, any person who knowingly sells, purchases, trades, counterfeits (or offers to do these things) a fake pharmaceutical product “shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.” Illegal drug counterfeiting, on the other hand, comes with an imprisonment of  “up to 20 years.” Penalties in developing countries are even more lax.

Interpol and the informal research group are using new technology involving an ion gun and mass spectrometers that can almost instantly identify what’s in a product and determine its authenticity. Interpol is also working with the UNODC, the World Health Organization, and the World Customs Organization to stop counterfeiting and drug trafficking.

These international efforts are well and good, but if the punishment doesn’t match the crime, what’s to deter counterfeiters? We don’t often hear of stakeouts of pharmaceutical counterfeiters on the news—because this crime is not a priority. If a counterfeiter can fake thousands of lots of pharmaceutical products, make several hundreds of thousands of dollars, and not get caught, what’s to stop him? Even if he does get caught, a fine of $250,000 is only a drop in the bucket compared with the money he may be bringing in. Meanwhile, thousands of individuals in need of real treatment may be getting a drug product that’s not going to help them because it’s fake. And meanwhile, a child is dying every 30 seconds from malaria.

We need a stronger system for punishing pharmaceutical counterfeiters before it’s too late.