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Posts Tagged ‘vaccines

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.

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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

20180703_Linkpost

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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July 3, 2018 at 2:19 pm

Science Policy Around the Web – April 27, 2018

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By: Michael Tennekoon, PhD

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source: pixabay

Productivity of Science

Is Science Hitting a Wall?, Part 1

Scientific research is hitting a wall- that’s the view from a recent study published by 4 economists.  The famous metric where the density of computer chips doubles every 2 years, now takes 18 times the number of researchers to accomplish. This pattern also extends to other areas of research as well. For example in medicine, “the numbers of new drugs approved per billion U.S . dollars spent on R&D has halved every 9 years since 1950”. In general, while research teams appear to be getting bigger, the number of patents being produced per researcher has declined. Alarmingly critics argue that some fields may even be regressing- for example the over-treatment of psychiatric and cancer patients may have caused more harm than the benefits.

But why would science be hitting a wall? One major factor could be the reproducibility crisis– the problem where many peer reviewed claims cannot be replicated thus calling into question the validity of the original research findings.  Researchers suggest that intense competition for funding and jobs, has resulted in the need to conduct innovative “high risk” research, in as short of a time as possible. While this type of research can gain plenty of press, they often lack the appropriate scientific rigor that ensure the findings are reliable. However, the perceived slow-down in research productivity could also be a result of the natural advancement of science- the low hanging fruit problem. Said another way, most of the easier problems have already been solved, leaving only problems that require vast scientific resources to solve.

On the other hand, researchers in some fields can rightfully pushback and argue that scientific progression is not stalling but is in fact accelerating. For example, technologies such as CRISPR and optogenetics have been able to produce a multitude of new findings particularly in the areas of neuroscience and genetics research. However, it must be noted, that even with these new technologies, the end product for general society is still relatively disappointing.

Given these concerns how scientific research moves forward raises some tough questions for the field. Given funding limitations, how much do we, as a society, value ‘pure science’- the effort to understand rather than manipulate nature? Scientific curiosity aside, in purely economic terms, is it worth understanding the out of Africa hypothesis of human origins, or sending humans to different planets? Is it worth investing in the latest innovative technology that produces new findings with limited applicability to human health? Scientists and the general society must be open to weighing the costs and benefits of scientific enterprises and deciding the avenues of research worth pursuing.

(John Horgan,  Scientific American)

Vaccine Ethics

The vaccine dilemma: how experts weigh the benefits for many against risks for a few

Cost-benefit analysis. Sure, it’s easy to do when you’re on an amazon shopping spree. But what about when millions of lives are at stake? And what if those millions of lives are of children, unable to give informed consent? Not so easy anymore, but that is the job of the Strategic Advisory Group of Experts (SAGE) for the World Health Organization, who last week decided to scale back the use of a new vaccine to protect against dengue.

2 years ago, SAGE concluded the vaccine was safe to use in children in places with high dengue infection rates, despite theoretical concerns the vaccine may increase the risk of developing a severe form of dengue in some children. Towards the end of last year, the vaccine’s manufacturer, Sanofi Pasteur, released new data validating these theoretical concerns.   How likely was this to happen? It was estimated that in a population where 70% of individuals had dengue at least once, the vaccine would prevent 7 times as many children from needing hospital care than would be needed as a result of the vaccine. If 85% of individuals had had dengue, that figure becomes 18 to 1. Those numbers were deemed not worth the risk.

What goes into making these decisions?

One factor is the prevalence of the disease. For example, the oral polio vaccine had the ability to prevent millions of children from becoming paralyzed, but it could also cause paralysis in a rare number of cases. In the 1950s and 1960s when polio was highly prevalent, it made sense to recommend this vaccine but as polio became nearly non-existent towards the end of the 20th century, using the oral vaccine was no longer prudent.

However, dengue is still rampant in today’s world, so what is different in this case?

Public perception. The modern world is highly litigious and has access to a wide variety of information, both facts and fake. This has resulted in a very skeptical perception of science where negative press for one vaccine could cause collateral damage for many other vaccines, unlike what would have happened a few decades ago. For example, in the 1950s, it was discovered that children were given a polio vaccine that mistakenly contained live viruses. This left 51 children in the US paralyzed, and killed 5. However, polio vaccinations resumed and the company responsible (Cutter Laboratories) went on and polio was virtually eradicated. On the other hand, RotaShield, a vaccine to protect against rotavirus (a virus that causes bowel blockage), had a very different experience. Approved in 1998, it was suspended one year later after the CDC estimated that for every 10,000 children there would be an extra 1 or 2 children who would get intussusception (a type of bowel blockage) over what would normally be seen. While in developing countries, the number of lives saved would have been far more than the extra cases of intussusception, the vaccine was still suspended. A safer rotavirus vaccine only made it to market in 2006. During this time, it is estimated that 3 million children died from rotavirus infections. (Note- risk of  rotavirus infections still persist even when the vaccine is given, but at far lower rates).

Given the tremendously difficult decisions that need to be made with the implementation of vaccines and the impact that public perception can have on these decisions, society has a responsibility to become more informed about the potential benefits and drawbacks of vaccines and must actively tease apart fact from fiction.

(Helen Branswell, STAT)

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April 27, 2018 at 3:26 pm

Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source: pixabay.com

FDA

FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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April 25, 2017 at 9:53 am