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Posts Tagged ‘vaccines

Should Vaccines be Mandatory?

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By: Juan I. Moliva, Ph.D.

Image by Angelo Esslinger from Pixabay 

The anti-vaccination movement has been gaining traction across the United States (U.S.) and the world. According to the Centers for Disease Control and Prevention (CDC), the number of measles cases in the first five months of 2019 surpassed the total number of cases per year for the past 25 years, with the number of children unvaccinated for preventable diseases quadrupling since 2001. The CDC also found an increase in the number of vaccine exemptions for kindergarteners across the U.S. While the numbers vary across the country mostly due to laws set in place by each state, in Mississippi, one of three states that do not grant exemptions due to religious or philosophical reasons, the rate of kindergartners with an exemption to one or more required vaccine was 0.1%. Compare that to Oregon, a state that grants exemptions to vaccines due to religious or philosophical reasons, where the rate of vaccine exemptions for kindergarteners is at 7.6%. As the number of individuals choosing not to get vaccinated or choosing not to vaccinate their children continues to increase, the debate as to whether vaccines should be mandatory has taken front stage.

Simply stated, a vaccine is a weakened or killed version of a pathogen that is delivered to the body with the sole goal of stimulating an immune response to protect you against the disease you are being vaccinated against. How is this accomplished? Your immune system has a subset of cells with “memory” that remember the pathogen and if you are later exposed to the pathogen these “memory” cells will eliminate the pathogen before it can make you sick. In the U.S. and most of the world, the general scientific consensus on vaccines is that they are safe and critical for maintaining healthy communities. The U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) strongly defended the case for vaccines. Chairman Lamar Alexander (R-TN) said, “The science is sound: Vaccines save lives – the lives of those who receive vaccines and the lives of those who are too young or vulnerable to be immunized.” Like any medication or medical procedure, vaccines do not come without risk, but the advantages vastly outnumber any disadvantages.

Not only do vaccines protect your body from dangerous pathogens, they also protect the community via a concept known as herd immunity. When a high enough percentage of the population is immune, pathogens have a harder time spreading. We rely on this principle to protect those who cannot receive a vaccine. However, vaccine opponents continue to argue that mandating vaccines is a slippery slope towards losing body autonomy. I have spent the last eight years studying vaccines, from basic research to pre-clinical testing through clinical trials and licensing. I have recently come to embrace the belief that the sole exemption for a vaccine that has been proven to be effective is a medical one – the case where you cannot receive a vaccine because your body responds negatively to the vaccine; this includes a weakened immune system that can be caused by chemotherapy or radiotherapy, a congenital condition that leads to an impaired immune system, or a history of serious adverse events related to vaccination such as an allergic reaction to one or more components in the vaccine.

The case against anti-vaxxers surrounds the choices they make on behalf of their children and how those choices affect their children and those in the community. If parents started claiming religious or philosophical exemptions against child safety seats or against buckling their children while driving, would we be arguing in their favor? Seatbelts and safety seats have been proven to save lives by preventing ejection from the vehicle after impact. Vaccines have been medically proven to save lives by preventing death or disability from infectious pathogens after exposure. While we expect not to be involved in a car accident, we rely on seatbelts in case we do. Vaccines work the same way; we do not want to be exposed to deadly pathogens but being vaccinated against these pathogens helps ensure we do not get sick if we do. Childrenare incapable of deciding if they want to be vaccinated as some vaccine regimens are initiated within the first year of life, thus their welfare is entrusted upon their parents. 

In the U.S. we have laws about providing proper nutrition, schooling, clothing, cleanliness, shelter, and many more that protect children’s welfare. Providing vaccines on time should be included as a basic necessity and be treated no different than other child welfare offenses. If an unvaccinated child contracts a preventable disease and is significantly affected to the point of disability or even death, the parent(s) should be directly responsible. A guardian refusing to vaccinate their medically eligible child should be treated like what it is: child endangerment. Take for example the recent case of a six-year-old in Oregon that nearly died of tetanus after sustaining a cut while playing outdoors. The child’s parents had refused to vaccinate the child with DTaP, a safe vaccine intended to protect against tetanus. The boy was held in an intensive care unit for 47 days, undergoing multiple intravenous infusions to alleviate the high fever, hypertension, and tachycardia caused by the infection. All at the cost of over $800,000 for a disease that could have been easily prevented with vaccination. Despite the episode, the boy’s parents continue to refuse the vaccine.

Although bipartisan support exists for vaccination at the federal level, it is unlikely federal law eliminating philosophical and/or religious exemptions would come to pass as public health policy is traditionally left to the states. State legislatures are beginning to introduce laws that will help limit the increase in numbers of preventable disease cases due to lack of vaccination. New York state recently passed legislation forbidding religious and non-medical exceptions to vaccines. After signing the bill, Governor Cuomo (D-NY) said, “While I understand and respect freedom of religion, our first job is to protect the public health.” Washington state, plagued by surging number of measles cases, also recently banned personal and philosophical exemptions to the MMR vaccine, which protects against measles, mumps, and rubella. Merely going to a public park or a grocery store can place unvaccinated children or immunocompromised individuals at risk of contracting a preventable disease. Such was the case of a six-year old boy with leukemia that died of measles after being exposed by his intentionally unvaccinated siblings. Senator Bill Cassidy (R-LA), a former physician, stressed: “If you are such a believer in liberty that you do not wish to be vaccinated, there should be a consequence and that should be that you cannot infect other people.” While I agree that autonomy over one’s body is important, the government has the right to require a reasonable level of vaccination for all citizens as a matter of public health. 

In the U.S. where freedom and personal liberty are valued above all else, mandatory vaccination would have a lengthy and challenging uphill battle. Additionally, data suggests that mandatory vaccination does not necessarily increase vaccination coverage. Instead, the U.S. could increase vaccinations via financial incentives similar to the system in place in Australia whereby parents receive monetary compensation when their children meet vaccination requirements. However, the most successful approach might be akin to the one the CDC implemented over sixty years ago to encourage stricter vaccination requirements by the states. By providing educational support, the CDC engaged parents, policymakers, and state and local health officials at every level to increase vaccination coverage. Education is one of the most effective ways to counter vaccination noncompliance. Specifically, educating people on the alternatives to vaccines – the morbidity and the mortality associated with lack of vaccination – was shown to be the most effective strategy. Educating why vaccines are so crucial is the most powerful weapon to combat vaccine non-compliance. 

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Written by sciencepolicyforall

August 14, 2019 at 10:00 am

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Disparity in the Global Supply and Demand for Vaccines Against Rotavirus

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By: Lawrence Wang

Image by Arek Socha from Pixabay 

Vaccines are extremely important for individual and global health. These life-saving biologics are especially important for children in developing countries, who suffer disproportionately from vaccine-preventable infectious diseases. One of these infectious diseases is rotavirus, which causes severe diarrhea and kills around 200,000 young children and babies per year1. Effective vaccines against rotavirus are responsible for saving countless lives and reducing suffering around the world.

In November 2018, the major pharmaceutical company Merck canceled a long-term commitment it made with GAVI (The Global Alliance for Vaccines and Immunization) to provide its rotavirus vaccine, RotaTeq, to four countries in West Africa (Burkina Faso, Cote d’Ivoire, Mali, and Sao Tome) for $3.50 a dose. Simultaneously, Merck increased RotaTeq shipments to China where a course sells for $40, nearly 12 times more than in West Africa2. Merck reported that the reason for this termination was “supply constraints” and an “unprecedented increase in global demand” for Rotateq3. Vaccines that were earmarked for West Africa were instead diverted to China, where they would protect millions of Chinese children while leaving millions of West African children vulnerable.

This situation exemplifies the disparity in the global supply of, and demand for, vaccines. Many vaccines are produced by large pharmaceutical companies like Merck that are based in wealthy nations (e.g., Merck’s headquarters are in New Jersey, USA). In general, developed countries have more agency in purchasing and providing vaccines for their citizens at higher prices. Developing countries, on the other hand, usually lack the money to pay for vaccines and are consequently reliant on free or subsidized vaccines. Profit-driven companies such as Merck are thus incentivized to sell their limited supply of vaccines to countries that can afford to pay more.

GAVI and UNICEF (United Nations Children’s Fund) are organizations that work to address disparities in vaccine access between industrialized and developing countries by buying and delivering vaccines to poor countries around the world4,5. However, they still rely on pharmaceutical companies to produce the vaccines that they distribute. When Merck notified GAVI and UNICEF that it would stop supplying discounted RotaTeq doses to the four West African nations, their only recourse to address the unexpected vaccine supply shortage was to help the affected countries switch to anot­­her rotavirus vaccine produced by a different company2.

This potentially problematic situation was avoided by a multilateral collaboration between aid organizations, governments, and manufacturers. Specifically, other pharmaceutical companies like GlaxoSmithKline (GSK), Serum Institute of India, and Bharat Biotech stepped in to fill the dearth left by Merck by pledging to supply their rotavirus vaccines (Rotarix, Rotavac, and Rotasiil) to the four West African countries. These countries are expected to switch to these alternative vaccines (which are actually cheaper than Merck’s) in 2020 after their supplies of RotaTeq run out6.

While this story ostensibly has a happy ending, it also highlights inherent problems in the way vaccines are supplied to the world, specifically poorer nations. These nations are reliant on aid organizations like GAVI and UNICEF to provide them with free or discounted vaccines, which are in turn dependent on profit-driven pharmaceutical companies to produce and supply the vaccines. Why can’t these multinational pharmaceutical companies, which have vast resources at their disposal, just produce more vaccines when there is a shortage?

The answer to this question is multifactorial. Firstly, vaccine production is complicated and only multinational pharmaceutical companies have the sufficient expertise, infrastructure, and manpower to produce high-quality vaccines that are safe and effective at scale. Thus, even these companies need advanced warning to produce millions of vaccine doses. Secondly, the prices for vaccines have been increasing in recent years, mostly due to high fixed overhead costs and exclusive licensing practices that preclude competition7. Thirdly, vaccines represent only about 2-3% of big pharma’s trillion-dollar production portfolio and are not the most profitable part of their portfolios8. Thus, pharmaceutical companies have little incentive to pick up the slack. How, then, can the costs of vaccines be reduced and who is supposed to step up to make vaccines when big pharmaceutical companies fall short of their obligations?

One potential solution to reduce the cost of vaccine production is for smaller pharmaceutical companies to produce generic vaccines. Generics are alternative versions of patented drugs and vaccines that are supposed to work just as well as the original formulation. In fact, India has become one of the world’s leading producers of generics and is a major source of vaccines and drugs for Africa. The issue with this solution is that the generics manufacturing industry is fraught with regulatory issues such as poor quality control and lack of oversight9. Africa is most starkly affected by these issues because manufacturers ship their lowest-quality drugs to the continent. Some of these products are completely counterfeit, with no active ingredients, while others have only a fraction of the active ingredients listed10. Without fixing quality control and oversight of generics manufacturing, this is not a viable long-term solution to provide vaccines to poor countries.

Another potential solution to increase vaccine coverage in Africa specifically would be to empower the continent to manufacture its own vaccines. Though Africa is home to nearly 17% of the world’s population, it produces less than 1% of the world’s vaccines and spends millions purchasing vaccines from foreign entities. For instance, African governments imported $900 million worth of basic vaccines for children in 201411. GAVI and UNICEF could partner with pharmaceutical companies to spearhead capacity building in specific African countries so they could produce their own vaccines, instead of making them dependent on vaccines from third parties. Apart from providing vaccines, this strategy would potentially build local biomedical capacity, provide jobs, and incentivize highly educated African expatriates to return to their home countries12.

Unfortunately, global vaccine stakeholders are hesitant to invest in building vaccine production capacity in Africa. For instance, profit-driven pharmaceutical companies tend to invest in healthy markets that will yield stable returns on their investments. Before investing in building a manufacturing facility, these companies must first ensure that the vaccines they produce will be bought for a certain price at a certain time12. Besides, It will be an uphill battle if Africa cannot produce vaccines more cheaply than other countries like India, which has already optimized infrastructure for producing vast quantities of vaccines cheaply13. Overall, there are many economic barriers that prevent Africa from developing its own vaccine manufacturing infrastructure.

In conclusion, the recent story revolving around providing rotavirus vaccine for West African countries exemplifies the complex challenges in supplying vaccines for the world, especially developing countries that contain some of the world’s most vulnerable populations. Despite the relatively vast resources that global organizations and companies like GAVI, Merck, GSK, and UNICEF have at their disposal, the demand for life-saving vaccines continues to outstrip the supply of vaccines. The bottom line is that vaccines are a vital component to the health of people and nations, and access to these medicines ought to be a universal human right.

  1. https://www.who.int/immunization/diseases/rotavirus/en/
  2. https://www.npr.org/sections/goatsandsoda/2018/11/01/655844287
  3. https://www.fiercepharma.com/pharma/amid-china-launch-merck-cites-supply-limits-plan-to-scale-down-rotateq-shipments-africa
  4. https://www.gavi.org/
  5. https://www.unicef.org/
  6. https://www.npr.org/sections/goatsandsoda/2019/05/31/726863111/it-looked-as-though-millions-of-babies-would-miss-out-on-a-lifesaving-vaccine
  7. https://www.who.int/immunization/programmes_systems/procurement/market/en/
  8. https://www.theatlantic.com/business/archive/2015/02/vaccines-are-profitable-so-what/385214/
  9. https://www.statnews.com/2019/07/22/indian-pharmaceutical-industry-drug-quality-charges/
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4105729/
  11. https://www.dw.com/en/africa-wants-to-manufacture-its-own-vaccines/a-46151389
  12. https://www.frontiersin.org/articles/10.3389/fpubh.2019.00056/full
  13. https://www.thehindu.com/sci-tech/health/trusting-the-science/article25861183.ece

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Written by sciencepolicyforall

August 7, 2019 at 2:45 pm

Science Policy Around the Web – April 26, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

World’s first malaria vaccine to go to 360,000 African children

On Tuesday, the World Health Organization (WHO) announced the launch of a large-scale pilot of the first malaria vaccine ever developed. 360,000 children under 2 years old will be vaccinated per year across three African countries (Malawi started vaccinating this week and Ghana and Kenya will began in the next couple weeks). The combined effort could immunize up to one million children by 2023. Children under five years old are at the most risk for life-threatening complications from malaria and more than 250,000 children in Africa die from the disease every year. 

The vaccine was developed by GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI) with support from the Gates Foundation. Data from clinical trials indicates it only provides partial protection, preventing around 40% of malaria cases. Thus, the vaccine is meant to complement existing solutions to preventing malaria ( e.g.bed nets, insecticide, and rapid diagnosis and treatment of the disease).  

Malaria is a parasitic infection that is transmitted via a bite from the female Anopheles mosquito. While the disease is preventable and treatable, an estimated 435,000 people die from it each year. The newly developed vaccine protects against P. falciparum, the most prevalent malaria strain found in sub-Saharan Africa.

The vaccine, known as RTS,S or Mosquirix, has taken decades to develop. It is given in four doses: 3 doses provided between the first five and nine months of age and the last delivered around the 2ndbirthday. While this is a big step, some malaria researchers are questioning the implementation of this vaccine when other, more effective vaccines are currently in clinical trials. However, even 40% efficacy will be very helpful in combating this devastating disease.

(Katie Hunt, CNN)

Drug Distributor And Former Execs Face First Criminal Charges In Opioid Crisis

For the first time, federal criminal charges were brought against a pharmaceutical distributer for its role in perpetuating the US’s deadly opioid crisis. Rochester Drug Co-Operative (RDC), the 6th largest distributor in the US, was charged with conspiring to distribute controlled narcotics (fentanyl and oxycodone), defrauding the United States government, and willingly failing to file suspicious order reports. Separate individual charges were also brought against two of their former executives.

Distributors connect drug makers to pharmacies and they are charged with monitoring drug distribution to ensure there is no abuse. However, this monitoring seems ineffectual at best. In one extreme example, an investigation by the Charleston Gazette Mail reported that a single pharmacy in the small town of Kermit, West Virginia (population 392) received 9 million hydrocodone pills over a two year period from out of state drug companies. 

In the RDC case, the US attorney in Manhattan, Geoffrey S. Berman, argues that greed has been the primary motivator for this abuse. Prosecutors said that RDC’s executives ignored warning signs and distributed tens of millions of fentanyl products and oxycodone pills to pharmacies they knew were distributing drugs illegally, resulting in massive profits. RDC has effectively admitted to violating federal narcotics laws and has agreed to pay a $20 million fine and will be supervised by an independent monitor over the next five years.

More than 700,000 people have died from drug overdoses over the last 20 years, the majority of which have been attributed to opioids, and some estimates predict hundreds of thousands more could die in the next decade due to opioid overdoses alone. 

Addiction treatment is underfunded in the US and the White House Council of Economic Advisers estimated that the crisis cost $500 billion in economic losses in 2015 alone. Hundreds of lawsuits across the country have been filed against opioid makers, producers, and distributors in hopes of holding them accountable, preventing misbehavior in the future, and receiving money to offset the costs of the crisis on the public. 

(Richard Gonzales, NPR)


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April 26, 2019 at 9:30 am

Science Policy Around the Web – April 9, 2019

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By: Mohor Sengupta Ph.D.

Image by Sasin Tipchai from Pixabay

Culture of Secrecy Shields Hospitals With Outbreaks of Drug-Resistant Infections

Large hospital settings are thriving spots for drug-resistant infectious organisms. Two recent cases are glaring examples of the problem. A recent report detailed a mysterious and newly discovered germ that was detected in a Brooklyn hospital last year. Doctors identified the culprit to be a fungus, Candida auris, that infects people with compromised immune system. Sooner than a blink in medical timeline, the fungus spread to Venezuela, Spain, South Africa, India and Pakistan. 

The man with the original infection at the Brooklyn hospital died, but the strain ofCandida auris lived on. It was detected in everything he had used and on all items in his hospital room. Recently the fungus showed up in Illinois and New Jersey. 

In January this year, CDC sent out an alert about another disease involving a type of the bacteriumPseudomonasaeruginosa, which is resistant to every known antibiotic. It was discovered at a Tijuana hospital. Multiple patients who had received weight-loss surgery, an invasive procedure, became infected. Several Americans that had traveled to Mexico to get this surgery contracted the indomitable P.aeruginosa infection.

Although the CDC regularly alerts Americans about lapses in medical care elsewhere, it often keeps incidents relating to deadly infections in American hospitals under wraps from public knowledge. 

For example, Klebsiella pneumoniae carbapenemase (KPC)-producing isolates are bacteria of the family Enterobacteriaceae that are resistant to the chemical carbapenem. This strain was first isolated in 2016 from clinical cultures in a small community hospital in rural Kentucky. However, it was not until 2018 that CDC reported the discovery, and the name of the Kentucky hospital has still not been released.

The CDC has claimed in the past that confidentiality is necessary to encourage hospitals to disclose infectious outbreaks to the CDC. Health officials agree that alerting the public about contained infections affecting only a small subgroup of people will create unnecessary panic in the larger population that might not be suitable hosts for the infection in the first place.  

However, that argument fails to contest instances where people died because hospitals did not come clean about an ongoing superbug infection. 11 people died from a contaminated medical scopein Virginia Mason Medical Center in Seattle between 2012 and 2014. 

Measures to pass Federaland state legislaturesin favor of promoting public knowledge about hospital infections have stalled on more than one occasion. 

It is important that drug-resistant infections in the hospital setting are made known to the public. It should be left to their discretion whether they should sign up for the hospital’s services. This knowledge is a fundamental right of the people and denying this knowledge to avoid fear, confusion and panic must be reconsidered.  

(By Andrew Jacobs and Matt Richtel, New York Times)


‘Monkey, Rat and Pig DNA’: How Misinformation Is Driving the Measles Outbreak Among Ultra-Orthodox Jews

“It is our belief that there is no greater threat to public health than vaccines,” says a page tucked inside the “The Vaccine Safety Handbook”, a parenting magazine. 

Over the fall months last year, men visiting New York from the middle east and Europebrought back measles with them, which efficiently spread into communities of orthodox Jewish people, mostly in un-vaccinated children. 

Rockland county is an example of an area of recent intense measles outbreak. Only 72.9 percent of people in the county between the ages of 1 and 18 are vaccinated. This number is far lower than the vaccinated percentage in general population. 

“The Vaccine Safety Handbook” gives spurious information to readers about vaccine manufacture process. “Vaccines contain monkey, rat and pig DNA as well as cow-serum blood, all of which are forbidden for consumption according to kosher dietary law,” Moishe Kahan, a contributing editor for Peach magazine, said in an email.

Resistance from ultra-orthodox communities have led to massive spread of measles in these neighborhoods, prompting Mayor Bill de Blasio to declare the outbreak a public health emergency needing mandatory vaccination, earlier Tuesday. The vaccine is given in two doses in children, at ages 1 and 5. It is 97 percent effective. 

Officials at the CDC said it “continues to be seriously concerned about the accelerating numbers of measles cases being confirmed nationally.” 

The measles virus is an RNA virus of the genus Morbillivirus. It exists as body fluid droplets released into the air from an infected person and can survive for two hours outside a host. 90 percent of unvaccinated people in its proximity will contract the disease.

Health officials have been consistently urging orthodox families to get their children vaccinated, but thanks to magazines such as “The Vaccine Safety Handbook”, their efforts are somewhat thwarted. Added to that, orthodox families tend to have many children, and it becomes difficult to keep a track of everyone’s vaccination schedules. Participation of infected children in social gatherings and attendance in schools have led to the spread of the infection in children and adults. Being an insular community, the measles outbreak has been largely confined to districts inhabited by the community.

 (Tyler Pager, New York Times)


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April 9, 2019 at 9:15 pm

Science Policy Around the Web – February 15, 2019

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By: Saurav Seshadri Ph.D.

Source: Pixabay

Hundreds protest against Washington state vaccine bill that would require measles shots

With over 58 people infected so far, the measles outbreak affecting the Pacific Northwest since January is a genuine public health emergency.  Still, local lawmakers are finding that they may have an even bigger challenge to overcome in preventing the next one.  The epicenter of the outbreak, Clark County, has one of the lowest vaccination rates in the country, with fewer than 80% of children receiving the recommended two doses of the measles-mumps-rubella (MMR) vaccine (far below the herd immunity threshold of 93-95%).  A bill sponsored by state Rep. Paul Harris, which aims to rectify this by limiting vaccine exemptions for non-medical reasons, was recently met with stiff opposition from anti-vaccination activists, who are particularly prominent in the region and turned out in the hundreds to protest.  Activists argue that the legislation would force parents to expose their children to risky medical procedures.  Such opposition, from groups such as Informed Choice Washington, prevented a similar bill introduced in 2015 from even making it to a vote.

However, while activists have been the most vocal and visible opponents of the bill, they may not be representative of the parents who are actually opting not to vaccinate in Clark County.  Portland is home to a large number of families from the former Soviet Union, many of whom are wary of vaccines for cultural or religious reasons.  Some Russian-language schools have vaccine exemption rates of over 50%.  The strain of measles in Clark County is the same one that recently sickened over 40,000 people in Ukraine, suggesting that the current outbreak may have originated within this community.  Any legislative solution may therefore have to tread carefully to avoid singling out a specific ethnic group.  

Furthermore, it’s unclear whether the proposed bill would be effective in promoting vaccination.  After a measles outbreak in 2015 that sickened 147 people, California eliminated ‘personal belief’ exemptions in both public and private schools; since then, medical exemptions (often issued with little justification and/or in exchange for a fee) have more than tripled.  While old studies linking vaccines to autism have been thoroughly debunked, their core message, that vaccines are inherently unsafe, has been tougher to eradicate.  This is partly because it bears a grain of truth: the CDC acknowledges that side effects of the MMR vaccine can include seizures and brain damage, and lists several scenarios in which its administration is contraindicated.  Despite these risks, in the wake of a potentially deadly outbreak, many will likely agree that public health must be prioritized and voluntary vaccination will resume.  If not, parents who truly fear the consequences of vaccination may be left with no other option but to educate their children at home.

(Ashley May, USA Today

Antidepressant based on party drug gets backing from FDA advisory groupT

Since 2006, scientists have known that the anesthetic ketamine is shockingly effective in treating depression.  Moreover, it can improve mood within hours, and is mechanistically distinct from existing antidepressants, meaning it can potentially help patients who are currently suicidal or whose depression is treatment-resistant.  While ketamine itself has been used as an anesthetic since the 1960s and cannot be patented, these findings were promising enough to motivate several drug companies to try to develop marketable variants.  One such compound, esketamine (produced by Johnson and Johnson), has just gotten a step closer to FDA approval: an independent advisory panel has voted to recommend its use for treating depression, based on the results of five phase III trials and several other supporting studies. The drug had previously received a Breakthrough Therapy Designation by the FDA, and an official decision from the agency is expected by early March.     

Ketamine is also a hallucinogen, a club drug known as Special K, a potential drug of abuse, and described by the DEA as ‘sometimes used to facilitate sexual assault crimes’.  Its transition to respectable pharmaceutical is therefore somewhat surprising, and could be indicative of a change in how such compounds are perceived by the government and society in general.  Medical marijuana is often prescribed to treat seizures, and last year, the FDA approved the first drug containing an active (though not psychoactive) ingredient derived from marijuana.  A more relevant example may be psilocybin, the active component of magic mushrooms.  The DEA describes psilocybin as a hallucinogenic drug of abuse, whose side effects include panic attacks, psychosis, and death; yet the FDA recently granted Breakthrough Designation to psilocybin therapy for treatment-resistant depression (a large-scale clinical trial, conducted by COMPASS Pathways, will take place this year).    

While the overall clinical efficacy reported by J&J for esketamine was modest, at least some panelists were convinced to approve the drug based on patient reports that its effects were worth any side effects.  As we enter the seventh decade since the discovery of the last novel antidepressant (or antipsychotic), such feedback may play a larger role in convincing regulatory bodies to try new treatments, even if they have been previously stigmatized or their mechanisms of action are unclear.  By allowing supervised administration, patient registration, monitoring, and research, bringing such drugs out of the shadows could provide welcome relief for people suffering from mental illness.  

(Sara Reardon, Nature)

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February 15, 2019 at 3:23 pm

Science Policy Around the Web – January 11, 2019

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By: Mary Weston, Ph.D.

1600px-aedes_albopictus

Source: Wikimedia

A Virus Even More Dangerous Than Zika to Pregnant Women

According to a recently published paper, Rift Valley Fever Virus (RVFV), a mosquito-borne virus found in Africa and the Middle East, may be even more damaging to fetuses than the Zika virus.

RVFV largely affects livestock, causing death and 90%-100% abortions in cattle. In humans, RVFV infections cause anything from mild flulike symptoms to severe liver problems. In 2016, a study associated the development of RVFV infection while pregnant with an increased likehood of miscarriage, but nothing further was known. However, a new study published last month in Science Advances shows that RVFV may severely harm human fetuses if contracted by women while pregnant.

The paper investigated how the virus affects pregnant rats, finding that 40% more pups died compared to uninfected controls and all surviving offspring contracted the virus. Further, the infected mothers’ placentas contained more virus than any other tissue. Upon testing human placenta tissue, they discovered that RVFV infects specialized cells that supports the region of the placenta where nutrients flow in, an area typically resistant to viral infections. According to the Dr. Amy Hartman, the infectious disease specialist at University of Pittsburgh who led the study, “Zika must take the ‘side roads’ into the placenta to infect a fetus, while the Rift Valley fever virus can take the ‘expressway.’”

Given that RVFV is carried by the same mosquitos found in Europe and America, there is a risk the virus could spread beyond Africa and the Middle East. Currently, there are no human vaccines or treatment for Rift Valley Fever and the World Health Organization has classified the disease as a potential public health emergency. Last week, the Coalition for Epidemic Preparedness Innovations launched a call for proposals to develop human vaccines against RVFV and Chikungunya virus, providing $48 million to finance up to eight projects

(Emily Baumgaertner, New York Times)

 

Prescription Drug Costs Driven By Manufacturer Price Hikes, Not Innovation

A new report published in Health Affairs argues that the rampant cost increase of many prescription drugs in the US is primarily due to price inflation, not the entry of new products or improvements to existing therapies.

The study compared pharmacy claims from the University of Pittsburgh Medical Center Health Plan and pricing data from First Databank, a company that collects prescription drug sales data, over the period of 2008-16. They found that the average costs of brand-name oral drugs annually increased 9.2%, while brand-name injectable drugs increased an average of 15.1% every year, five to 8 times the rate of general inflation. For example, the Health Care Cost Institute cited that the cost of insulin doubled from 2012-16.

The costs of generics and specialty drugs also increased during these time periods, but the authors determined that was due primarily to new product entry. During 2008-16, many blockbuster brand-name medications, such as Lipitor, lost their patent protection. There is typically lag time between becoming a generic and the time required to file generic applications. Thus, initial prices of generics are more closely matched with brand-name prices until more competition enters the marketplace, which factored into the report’s observed increase in generic pricing.

William Shrank, the chief medical officer of the UPMC Health Plan and an author on the study, argues that since rising costs are not improving treatments, policy makers may want to get involved. “This observation supports policy efforts designed to control health care spending by capping price inflation to some reasonable level,” he says.

Total US spending on prescription drugsin 2017 was $333 billion, a 0.4% increase from 2016, but a 41% increase compared to $236 billion in 2007. Additionally, according to a 2017 Commonwealth Fund study, US residents pay more for medications than any other high-income countries. Recently, efforts towards lowering/regulating prescription drug costs has received bipartisan support and this new report may help further those proposed regulations.

(Alison Kodjak,NPR)

 

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January 11, 2019 at 4:44 pm

Science Policy Around the Web – July 3, 2018

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By: Jennifer Patterson- West, PhD

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source: wikimedia commons

Women’s Health

Pregnant Women: Avoid Soft Cheeses, But Do Get These Shots

During pregnancy, expecting mothers are advised to avoid a slew of activities, foods and medications to protect their unborn child including alcohol, unpasteurized cheese, lunch meat, ibuprofen and even hot baths.  What may come as a surprise is that the American College of Obstetricians and Gynecologist (ACOG) recently released an immunization guide that advise expecting mothers on which vaccine to receive during pregnancy and which to avoid.  It also highlights vaccines that should only be given to high risk patients or immediately following birth.

The influenza vaccine is given to protect the mother who is more likely to get seriously sick if she contracts the flu. The Tdap vaccine is recommend at 27-36 weeks of gestation during each pregnancy to boost the maternal immune system in order to protect the newborn.  In addition to this recommendation, the CDC also recommends anyone who plans to come in contact with the baby receive the Tdap vaccine at least 2 weeks prior if they are not up-to-date with their vaccines.

In 2015, 20,762 cases of pertussis, the infectious agent responsible for whooping cough, were reported to the CDC by the State Health Department. Although this is a 37% decrease compared to 2014, these numbers can be further improved by improved coverage of those in contact with unvaccinated infants.

The goal of these guidelines is to further reduce the number of cases of whooping cough in babies younger then 3 months old, a time when the disease is most fatal.  For babies that contract whooping cough, half of them will end up in the hospital and some will die. Although these recommendations are not new, many expecting parents may be unaware of what vaccinations should be received during pregnancy. The CDC estimates that only half of pregnant women in the United States receive the Tdap vaccine.

(Selena Simmons-Duffin, NPR)

Drug Approvals

FDA approves Country’s first medicine made from marijuana

On June 25, the FDA announced the approval of the first drug with an active ingredient derived from marijuana.  Epidiolex is an oral solution approved for the treatment of seizures associated with  Lennox-Gastaut syndrome and Dravet syndrome.

Both are rare and severe forms of epilepsy.  Lennox-Gastaut syndrome typically presents between the ages of 3 and 5 as frequent seizures. The majority of children with the syndrome exhibit learning and intellectual disabilities and delayed motor skills.

Dravet syndrome is a rare genetic disorder that presents as frequent fever-related seizures during the first year of life.  Children with this disorder commonly have underdeveloped language and motor skills. With age, other seizure types and symptoms typically arise that are potentially life-threatening. No drug had previously been approved specifically for the treatment of Dravet syndrome, which is why FDA granted Priority Review to the application and orphan drug designation.

The approval of Epidiolex has the potential to increase the quality of life for many patients with these rare syndromes The active ingredient derived from marijuana is cannabidiol (CBD), which was shown to be effective at reducing the frequency of seizures compared to a placebo in clinical trials.  Epidiolex does not contain THC, the psychoactive component of marijuana, that causes a euphoric high.

CBD is currently classified as a Schedule I substance in accordance with the Controlled Substance Act (CSA).  Schedule I substances include drugs or chemicals with no accepted medical use and a high potential for abuse.  Although more than thirty states have passed legislation that permits the use of medical marijuana or CBD, cannabis is still categorized as a Schedule I substance under the CSA.

The approval of Epidiolex provides a path forward for the approval of other marijuana-derived medications, or treatment of additional indications, that do not conflict with federal law.  The FDA Commissioner, Dr. Scott Gottlieb, stated that “We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”

(Andrew Joseph, STAT News)

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Written by sciencepolicyforall

July 3, 2018 at 2:19 pm