Posts Tagged ‘public health policy’
By: Shakira M. Nelson, PhD, MPH
For many, the Trans-Pacific Partnership (TPP) was a point of great debate during the 2016 Presidential primaries and election. As a simplified explanation, the TPP is a free-trade agreement involving the United States, Canada, Australia, Japan, New Zealand, Mexico, Chile, Peru, Brunei, Malaysia, Singapore and Vietnam, intended to “level the trading playing field” through the elimination of tariffs and other laws that create trade barriers. In its final form, the TPP would impact up to one-third of world trade and 40% of the global gross domestic product. Many who debated the ramifications of the TPP did so in the context of foreign policy interests. Although aligned with foreign policy, a major part of the TPP deals with intellectual property protection, and pharmaceutical drug development. If implemented, the effects of the TPP could greatly diminish public access to affordable medicines, both domestically and internationally. Moreover, the stronghold the TPP places on intellectual property could limit the development and marketing of less expensive options.
Intellectual property can be divided into two categories: industrial property and copyright. Patents, trademarks, and industrial design fall under industrial property. Patent development is a large part of scientists’ work, seen as almost a necessity to incentivizing innovation. Many argue that, without the ability to patent inventions and significant findings, scientists would not be able to generate profits used to sustain research and development; within the pharmaceutical industry, patents are the proverbial bread-and-butter. When in place, patents create a stronghold around the release of new chemical drugs, which prevents competition by generic brands. The standard length of time of a patent for a chemical drug is 20 years, which starts from the time the drug is invented.
Many new medicines under development today fall under the category of ‘biologics’. As the name suggests, biologics are treatments made from biological sources, and are very different from chemical drugs. Created to treat a multitude of diseases, including Ebola and cancer, biological sources include vaccines, anti-toxins, proteins, and monoclonal antibodies. Given their structural complexity compared to traditional drugs, and use of recombinant DNA technology, biologics are more difficult, and costlier to make. Moreover, manufacturers have a greater burden in ensuring product consistency, quality, and purity over time. This is done through certifying that the manufacturing process remains the same over time. Because of this, it is estimated that the price to manufacture biologics cost on average more than 22 times the price of chemical drugs. Current laws state that generic biologic development, known as biosimilars, cannot be approved until 12 years after the branded product has been approved – this is known as an exclusivity period. This was enacted under the Biologics Price Competition and Innovation Act of 2009, by the Food & Drug Administration (FDA).
The challenge with current policies is establishing a period-of-time that balances the need for companies to generate profits and cash flows, which will incentive them to conduct more research and compensate them for the extensive manufacturing processes, with the need to provide greater access through launching generic drugs and biosimilars. The trouble with the proposed policies of the TPP agreement is that they seem to embolden the pharmaceutical companies by introducing changes that would prevent competition from generics and biosimilars for longer periods of time than the current basic terms. The implications of this are far-reaching, as it may lead to a significant increase in the current costs of pharmaceutical drugs and biologics, hindering the health of the patients who rely upon these treatments.
Critics of the current system of patent length and biologic exclusivity periods fear that rather than incentivizing innovation, companies are being rewarded through their ability to charge higher amounts for drugs without the fear of competition on the market. Health policy experts concur, identifying policies such as the Hatch-Waxman Act of 1984 in allowing for the creation of drug monopolies, and “going too far in compensating the pharmaceutical industry at the public’s expense”. A report released in 2009 by the Federal Trade Commission stated that biosimilar development was more difficult to achieve than traditional generic drugs. For example, development requires comparisons to the original biologic, to prove efficacy and equivalence. Biosimilars must share the same mechanism of action, with no clinically significant differences in terms of safety or potency for the approved condition of use. The steps necessary to achieve this are significant, and therefore imposing a 12-year exclusivity period on biologics may be unnecessary. US Congressmen have pushed to compromise, floating an amendment to the TPP that would lower the exclusivity period to 8 years. However, critics and patients who rely upon drug competition to lower market prices, have protested this amendment stating that costs of new drugs and biologics are too high, and 8 years is too long of a length of time to wait for affordable generics and biosimilars to come on to the market.
The impact of decreasing the length of time it takes for biosimilars to come onto the market can be seen with Neupogen, a leukemia drug that was first approved by the FDA in 1991. Delivered via injection, Neupogen costs patients $3,000 for 10 injections. With injections needed daily, this drug could carry a price tag of well over $100,000 per year. It wasn’t until recently, however, that the first biosimilar was approved on the US market. The biosimilar, Zarxio, was approved as a leukemia drug and is priced at more than $1000 less than Neupogen. This pricing has the potential to decrease the yearly costs of this drug from $100,000 with Neupogen to $55,000-$75,000. Further evidence of these financial savings was provided by the Rand Corporation, which predicted a savings of over $44 billion over 10 years with an increased approval of biosimilars, for patients who rely upon these specific cancer treatments.
Internationally, the policies of the TPP also have far reaching effects on the availability and costs of pharmaceuticals. The 12-year exclusivity period would be imposed upon the other countries involved in the TPP, where currently for some, such as Brunei, there is no current exclusivity protection. By imposing the 12-year period, global competition could become restricted. Additionally, the TPP proposes other key patent protections that play a bigger role on the international market. One protection, known as evergreening, allows drug companies to request patent extensions for new uses of old drugs. The immediate effect of this is an extension of monopolies on drug sales for minor reasons. The second protection allows pharmaceutical companies to request patent extensions if it takes “more than 5 years for an application to be granted or rejected.” Advocacy groups fear that the price of drugs would undermine the efforts of health initiatives, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria. These initiatives rely upon price competition to manage costs, with the availability of cheap generics helping drive costs down.
Although the current administration has ended the USA’s association with the Trans-Pacific Partnership, it is important to note that other countries may try to implement some of the policies, affecting the availability and affordability of drug treatments. To decrease this burden, the US could work to assist in negotiating exceptions for the poorer and smaller countries, to help them meet any challenges they may come up against. Within the US itself, it is important for policies, laws and any future trade agreements to be modified, with more of a focus on the affordability and regulation of drugs and biologics. Imposing price controls may offer a modest benefit, but may not be a long-term solution. A focus on lowering the patent length for new drugs and biologics can be an immediate step. Although the push back from pharmaceutical lobbyists will be substantial, alleviating the financial burden on families afflicted with cancer and diseases should be the focus.
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By: Rachel Zamoiski, Ph.D., MPH
Zika virus has been all over the news lately, but it hasn’t been that long since a different virus was making headlines all over the world: Ebola. The Ebola epidemic of Western Africa, which began in 2014 and ended in January 2016, has resulted in over 28,000 Ebola diagnoses and over 11,000 deaths. While the seemingly near-constant news updates on Zika may remind us of the media coverage of Ebola, the two diseases are very different from each other. However, there are still lessons to be learned from the Ebola outbreak that can be applied to how we deal with this potential Zika epidemic.
The illnesses caused by Ebola and Zika are very different from each other. With Ebola, the main concern is the disease itself. Ebola is often fatal, especially in settings without good infrastructure or advanced medicine. The symptoms of Ebola are severe and can involve severe vomiting and diarrhea, as well as uncontrolled bleeding. Ebola is transmitted by contact with the body fluids of an infected person, even after the patient has died. In contrast, the symptoms of Zika are mild. It’s uncertain exactly how Zika is spread, but the primary route of transmission of Zika appears to be via mosquitoes and not direct contact with infected individuals, although other routes of transmission may be possible, as limited reports have emerged of sexual transmission. In addition, recent reports state that scientists have found active virus in saliva and urine, although it is not known if those fluids could transmit the virus. The actual symptoms caused by Zika virus is not particularly concerning when compared to Ebola. While the symptoms of the disease caused by Ebola and its high case-fatality rate were the main concerns of the Ebola outbreak, the greatest concern with Zika is the possible effect on fetuses when pregnant women are infected.
An article in Morbidity and Mortality Weekly Report from January 29, 2016 describes a “possible association” between Zika and microcephaly in babies born to mothers infected during pregnancy. The authors report an increase in cases of microcephaly, defined as a head circumference greater than two standard deviations below the mean, adjusted for gestational age and sex. The babies with microcephaly were born to mothers who either lived in or had visited areas with current Zika outbreaks. The article states that pregnant women should try to avoid contact with mosquitoes, while also noting that “further studies are needed to confirm the association of microcephaly with Zika virus infection.” While the link between Zika and microcephaly is still not well understood, it still seems prudent to advise pregnant women to avoid contact with the virus, out of an abundance of caution.
While it is important to be cautious and not expose people to unnecessary risk, even when the risk is uncertain, it’s also true that an overabundance of caution is not always a good idea. With Ebola, there were efforts to quarantine health workers returning from West Africa even when they posed no threat to public health. These efforts were made largely by politicians, and not by people with medical or scientific expertise, who instead recommended routine monitoring but not quarantine in asymptomatic individuals, as patients needed to be symptomatic in order to transmit the virus to others. This is in contrast with the well-known case of Typhoid Mary, a woman working as a cook who was forcibly quarantined because she was infecting people with typhoid even though she was not sick herself, and was unwilling to stop working as a cook. In situations like that of Ebola, not only does forced quarantine punish people for performing work that should be celebrated and honored, but it also potentially discourages healthcare workers from traveling to disease-ridden areas by stigmatizing them and treating them like prisoners unwelcome in their own country.
Less is known about Zika than about Ebola. With Zika, we don’t really know how infectious it is, or exactly how it’s transmitted. But what lessons are there to be learned from Ebola, to guide our response to Zika?
It’s important to take emerging infectious diseases seriously. One of the downsides of having such effective vaccines against formerly-common illnesses like measles and mumps is that we can forget how powerful and widespread viruses can be. The Ebola outbreak reminded us that viruses still have the potential to infect and kill many thousands of people, both far away and close to home.
Included in the threat of infectious diseases is the widespread fear caused by the perception of a seemingly unstoppable deadly virus. This understandably scared many people and undoubtedly contributed to the unscientific overreaction by many politicians. This underscores the need for good communication in the management and control of infectious diseases. If a politician announced plans to forcibly quarantine cancer patients, there would be widespread outcry and ridicule, because the general public understands cancer well enough to know that quarantine is not an effective method of preventing cancer. The same should be true for new public health concerns as well.
Finally, good data are paramount in understanding and implementing effective methods to prevent and disrupt transmission. Our efforts should focus on collecting good data, clarifying the risks of Zika, and better understanding how it is transmitted, as well as how it’s not transmitted.
With Zika, we should be cautious, and take precautions to avoid the virus even when we don’t fully understand its effects. At the same time, our response to this public health crisis, as well as others in the future, should be based on good data, and not politics or scare tactics.