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Science Policy Around the Web April 10th, 2020

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By Thomas Dannenhoffer

image by geralt from pixabay

NIH’s process for removing reviewers remains a mystery, watchdog finds

The Department of Health and Human Services’ Office of Inspector General released a report detailing their investigation of the processes that remove grant reviewers from the reviewer pool. Each year the NIH reviews over 80,000 grants and over 25,000 reviewers volunteer to judge the merits of each grant so that the most promising research gets funded. This investigation by the OIG was initiated by Congress after NIH Director Francis Collins made a statement about concerns over peer reviewers sharing confidential information with foreign entities. 

The OIG conducted their investigation by interviewing the NIH staff who are responsible for implementing policy related to peer reviewer’s handling of information, as well as reviewing the NIH policies and training materials relating to oversight of peer reviewers. The investigation found that the NIH has taken measures to ensure confidentiality. This includes trainings provided to the reviewers and non-disclosure agreements. The NIH relies mostly on other peer-reviewers to report instances of confidentiality breaches. Over 75 researchers have been flagged as “do not use” since November of 2019 because of confidentiality breaches, but not all reviewers who break the rules are removed from the reviewer pool. The NIH does not provide guidelines for the removal of compromised reviewers, instead relying on a case-by-case analysis. 

The report claims that the NIH is taking measures to reduce breaches in confidentiality but could be doing more. OIG has made several recommendations to reduce confidentiality breaches, all of which the NIH concurred with. One recommendation made was the use of “targeted, risk-based oversight” in which threats are determined by risk indicators. The report does not provide any risk indicators, instead recommending that the NIH perform research on integrity threats to determine them. Collins announced that he will file a report in the fall detailing how the suggestions of OIG will be implemented. 

(Jeffrey Mervis, Science Magazine)

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April 9, 2020 at 3:07 pm

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Science Policy Around the Web February 4th, 2020

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By Maria Disotuar PhD

Source: Flickr

Embryo Research To Reduce Need For In Vitro Fertilization Raises Ethical Concerns 

The year 2019 ended with the publishing of a controversial and potentially unethical study completed in Mexico in which  81 women were paid approximately ~$1400 to be injected with synthetic hormones, artificially inseminated, and have their embryos flushed out of their bodies (a procedure known as uterine lavage) to test them genetically and analyze their morphology. A subset of 20 out of the 81 women followed the procedure by a cycle of in vitro fertilization (IVF)  to compare the embryos produced in the lab versus the embryos produced via uterine lavage. In the study, scientists were able to recover 42% of the flushed embryos and 70% of these embryos were of good quality. The scientists noted the embryos recovered via this method had better morphology than those recovered via IVF and the chromosomal variations were similar between the two methods. 

Currently, IVF is the most common type of assisted reproductive technology(ART) but it can cost over $20,000 per cycle, and according to the Society for Assisted Technology (SART) the rate of single births per IVF cycle can vary from 4% to 41% depending on a woman’s age. Dr. Santiago Munne, the principal investigator of the study, hopes the new method could one day replace IVF. He hopes this new alternative, once perfected, will increase birth rates since the procedure is completed in vivo, lead to a reduction in chromosomal abnormalities, reduce costs, and provide an alternative method for couples struggling to conceive.

Yet, some bioethicists and scientists across the globe have described the study as troublesome, unethical, and dangerous. They worry the women were used as “petri dishes” for a procedure normally reserved for individuals experiencing infertility problems. More worrisome is that some of the women underwent chemical or surgical abortions after some of the embryos were not successfully removed during the procedure. Despite these concerns, Dr. Munne notes the study was approved by the Ministry of Health of the State of Nayarit, in Mexico, and the Western Institutional Review Board in the United States. Additionally, some scientists acknowledge the study was well done and could have a positive impact on reproductive research and may help couples conceive at a lower cost in the future. Finally, the study has helped couples struggling with infertility as some embryos have been used to produce healthy babies. The remaining embryos have been frozen for future use by other couples. 

Rob Stein, NPR 

FDA and NIH let clinical trial sponsors keep results secret and break the law

The federal government mandates research institutions report all clinical trial results so that doctors and patients can make informed decisions about disease treatment plans. In January 2018, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) established a “final rule” to clarify the expectations, rules, and penalties for not disclosing the results from clinical trials. Based on this mandate clinical trial sponsors must submit data and results within 1 year after the completion of a clinical trial.  Now, two years after the establishment of the mandate, a Science investigation shows that clinical trial sponsors are not obeying the law and very little is being done by the federal government to address the issue. 

The investigation looked at more than 4700 trials registered on ClinicalTrials.gov and found that while reporting rates for some pharmaceutical companies and universities had increased since the establishment of the rule, 31.6% of sponsors had not reported their results to the website and 23.7% had reported their results past the 1 year time frame. In the months leading to the establishment of the rule the FDA and the NIH promised stiff penalties for violators – including fines of up to $12,000 a day and cutting grant funds for not reporting the results of the trials on time. This was promised as a measure to enforce the mandate and maintain compliance within the research community. Yet, the findings of this investigation clearly show that neither the NIH nor the FDA are fulfilling their promises, and sponsors are not being penalized for withholding vital information from the public. 

(Charles Piller, Science) 

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February 4, 2020 at 9:16 am

Science Policy Around the Web October 22nd, 2019

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By Mohor Sengupta PhD

Image by truthseeker08 from Pixabay 

What’s Behind The Research Funding Gap For Black Scientists?

A recently published study by a group of NIH investigators has found possible reasons for the funding gap that exists between grant proposals submitted by black and white researchers. This gap was first revealed in a report published in 2011 that found that black applicants to NIH grants were awarded funding at a significantly lower rate than white applicants to the same grant. These data prompted the NIH to investigate the grant funding process.

In this paper, the authors analyzed keywords in grant application topics and found that some topics were four times more likely to get funded than others. Broadly, topics dealing with the mechanistic basis of science on a micro-level, such as genetics, or cellular mechanisms were more likely to grab the attention of grant reviewers than grants involving population sciences and community-oriented research. Grants on these subjects are more commonly proposed by African American applicants. 

The authors find that black researchers tend to pursue studies on topics that are more connected with their communities. Such topics include health disparities research, which unfortunately don’t figure as priority in grant reviewers’ radar, possibly because they don’t see things through the same lens when evaluating proposals. This may be because the grant reviewers didn’t have similar life experiences while growing up as a person belonging to a minority community might have. In the present study, only 2.4% of grant reviewers was black. 

In the study, self-reported demographic data of applicants was not visible to grant reviewers. As a next step, the authors will investigate if applicant anonymity decreases the existing funding gap. 

(Emily Vaughn, NPR)

Marijuana and Vaping: Shadowy Past, Dangerous Present

A severe lung disease has been affecting users of e-cigarettes with marijuana. So far nearly 1500 people have become sick, and 33 have died of the mysterious disease. Residents of 49 states and the District of Columbia have reported the vaping-related illness. While the cause of the disease remains unknown, experts say that THC, the chemical in marijuana that makes people feel high, produces different components when burned in rolled joints versus when aerosolized in vaping devices. The latter may have unknown harmful chemicals. 

However in addition to THC, vaping oils contain additives, solvents and flavor enhancers. It is unclear which of these ingredients is the culprit, but vitamin E acetate is a likely candidate for the illness. The obscurity surrounding illness-causing vaping components in part exists because of restrictions imposed on cannabis research by the federal government. The reason behind this is the high abuse potential of cannabis, which classifies it as a controlled substance not available for research. 

This rule annoys scientists and industry experts alike. Lack of hard science and awareness among the vaping community is made worse by the many cheaper products freely available in black markets, both in states where vaping THC is illegal and legal. As counterfeit cartridges are much cheaper than the tested and taxed licensed products, these have many consumers. Vaping cartridges sold on the black market are not tested.

Considering the recent illnesses taking a toll on people who use e-cigarettes to smoke cannabis, the government should allow investigation into the chemical underpinnings of the disease. 

“I’m not able to take products we think are potentially harmful and do analysis. I can buy a vape device around the corner, but I can’t bring it into the lab and test it,” UCSF researcher on nicotine and vaping, Dr. Neal Benowitz said. Benowitz has sent a letter to the congress about the hugely popular and unstudied practice of vaping. 

(Matt Richtel, The New York Times)

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October 22, 2019 at 4:09 pm

Science Policy Around the Web September 30th, 2019

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By Allison Dennis B.S.

Image by Gerd Altmann from Pixabay 

23andMe, moving beyond consumer DNA tests, is building a clinical trial recruitment business

Clinical trials are often criticized for poor patient recruitment that inadequately represents patients from minorities, e.g., women of reproductive age, racial minorities, underserved patient populations and people with rare genetic diseases. To fight this, 23andMe feels that its vast database of patients comfortable enough to trade their genetic information and a small bit of spit to learn more about their genetic predisposition to disease and heritage could be a much-needed recruiting tool for those enrolling patients in clinical trials, and one they would be willing to pay for. 

23andMe can mine the database of their 8 million potential research participants to identify which customers fit the needed demographics and genetic profiles relevant for studying a particular drug. For example, 23andMe found about 7,500 carriers of a rare mutation in the gene LRRK2, a potential target being pursued by GlaxoSmithKline to prevent the progression of Parkinson’s disease. In patient populations, this mutation is only found in one in a thousand people, meaning it would take years to identify enough participants to enroll in a trial. With enough potential participants to choose from trial managers are hoping to to recruit local patients, allowing them to overcome the costs of paying for patient travel and ease the stress patients experience by spending extended time away from home.

To augment the diversity of their database, 23andMe has launched programs to provide free genetic analysis to people whose four grandparents were born in the same country. The Global Genetics Project focuses on underrepresented countries like Mali, Tajikistan, and Paraguay, while the African Genetics Project focuses on the ethnic and tribal groups of countries such as Cameroon, Ghana, Libera, and Senegal. By starting with the genomes of people with clearly known ancestry to better define the genetic differences common to them, 23andMe is hoping it will be able to improve its unravelling of more complicated genetic lineages. A greater diversity of enrollees is sure to appeal to clinical trial recruiters, who are trying to meet FDA guidelines designed to enhance the diversity of clinical trial populations.

It remains to be seen how receptive 23andMe customers will be to being targeted for participation in clinical trials. Many of the 8 million may not have fully realized that consenting to genetic research would potentially extend to drug companies paying for their data. However, for many people, the possibility of playing a role in the discovery of cures for genetic diseases may outweigh privacy concerns and any initial discomfort from being singled-out. 

(Rebecca Robbins, STAT News)

NIH reveals its formula for tracking foreign influences

NIH’s extramural research program is struggling to find the balance between curbing inappropriate information sharing, fostering the international collaboration recognized as necessary for the global pursuit of science and maintaining some level of ease in the grant application process. The grants that are distributed by NIH are won following review by a panel of experts, composed of about 27,000 reviewers recruited to serve on committees by NIH each year. It is believed that some reviewers have violated NIH policy by sharing the confidential contents of grant applications with international colleagues. The data and research approaches described in grant applications is proprietary and often has the potential to result in patents in addition to publications. 

A more complicated scheme concerning officials involves international researchers setting up labs in parallel, one in the US to win grant money, and one in a foreign country where the grant winner wishes to benefit from any emerging intellectual properties stemming from the funded research. Such an arrangement allows US funded discoveries to be transferred to another country without any oversight from the US government. 

It is difficult to clearly spot scientists unfairly leveraging their role in NIH grant giving activities. While grant reviewers are not supposed to share any parts of the application, it is common for researchers to share grants with trainees in their lab, sometimes seeking relief from the burden of review by having junior researchers take the first look, other times viewing it as a needed opportunity for future grant-seekers to become familiar with the process. Grant applicants routinely have joint appointments with international institutions. This is acceptable if clearly disclosed when they seek funding from NIH. 

In the past the issue has been treated as a regulatory hot potato, NIH requires grant seeking institutions certify the grantee listed on the application, institutions rely on the assumption that foreign scientists would be denied visas by the US Department of state if they were thought to have improper ties to their home countries. Of course, citizens that are US citizens are at risk of behaving improperly as well. NIH is taking the next sixth months to develop a risk-based approach to flag potential conflicts with reviewers. As a first step they are considering moving grant reviews to a read-only online portal to prevent any untracked distribution of downloaded applications. 

 (Jeffrey Mervis, Science)

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October 1, 2019 at 11:32 am

Science Policy Around the Web August 26th, 2019

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By Silvia Preite PhD

Image by PublicDomainPictures from Pixabay 

NIH will soon share genetic data with those who participated in precision medicine study

In 2018 the National Institutes of Health (NIH) launched the All of Us Research Program to collect multiple types of data from more than one million volunteers living in the United States. The aim of the program is to accelerate medical breakthroughs and promote human health on a large scale. All of Us is a key element of the Precision Medicine Initiative (PMI), with the long-term goal of integrating information on genetic composition, lifestyle and environment to reveal strategies for personalized prevention and treatment of a wide range of health conditions. 

Participants provide medical records along with genomic material, blood and urine samples. In addition, digital data recorded through smart phones and other electronic devices are stored to obtain extended pictures of the individual health status and life habits.

So far, about 200,000 Americans have joined the All of Us initiative. By late 2019-early 2020, 25,000 US citizens will get back their genomic information along with genetic counseling. On August 21 2019, the All of Us director Eric Dishman announced a new partnership with the California-based health technology company, Color Genomics to provide the counseling service. The genetic counseling services provided by Color Genomics will play a crucial role in communicating the genomic results to participants and their personal physicians, as well as helping them understand the implications for their health and families. These data will supply information on genetic variants that could predispose to certain diseases and influence responses to pharmacological treatments.

In particular, counseling will be given to those individuals who carry any genetic mutations that geneticists have linked to severe diseases – such as mutations in the BRCA gene associated with breast cancer.

This will be the first time that a government funded study will return genetic data to the participants on such a large scale. Another distinguished element of this study is the heterogeneity of the involved population. Up to now, half of the participants have been selected within ethnic and socio-economic groups that have been historically marginalized and under represented in research and clinical studies. Moreover, researchers could gain access to these open-source and anonymized data to investigate previously unknown genetic traits that influence human health and disease development, greatly broadening the availability and heterogeneity of data for these studies.

(Lev Facher, STAT News)

 

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August 27, 2019 at 2:38 pm

Science Policy Around the Web – June 7th, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?

Last Tuesday, the Washington Post reported that the biopharmaceutical company Pfizer had hints that their rheumatoid arthritis drug Enbrel might reduce the risk of Alzheimer’s disease, but chose not to report these findings to the public.

In 2015, after analyzing hundreds of thousands of insurance claims, a team of Pfizer researchers observed that their anti-inflammatory drug Enbrel might also decrease the risk for Alzheimer’s by 64%. They recommended that the company conduct a costly clinical trial to prove the link but, after several years of internal debate, the company decided not to pursue the lead.  The question remains: why did Pfizer not release these findings to the scientific community?

Pfizer claims they did not pursue the research due to scientific considerations – they argue that since Enbrel cannot cross the blood-brain barrier and directly reach brain tissue, it is unlikely to prevent the debilitating neurodegenerative disease. Further, Pfizer claimed that they did not to report the research because the statistical findings did meet “rigorous scientific standards” and were concerned about misleading researchers down a false path. However, Pfizer is also losing its patent protection on Enbrel soon, meaning that generics will become available and the drug will be much less profitable, reducing any financial incentive for further research or clinical trials (likely to cost around $80 million).

Some in the scientific community are questioning Pfizer’s justification. Keenan Walker, an assistant professor of medicine at Johns Hopkins, argues that the scientific community benefits when the data is available, stating that ““[w]hether it was positive data or negative data, it gives us more information to make better informed decisions.’’

Several scientists argue that Pfizer’s results should be release because they could provide clues to combating the disease and slowing cognitive decline in its earliest stages. Specifically, recent research is hinting that inflammation may promote Alzheimer’s disease. Further, neurodegenerative research is notoriously challenging and there are no major drugs that treat Alzheimer’s. Even several recent phase 3 clinical trials have been halted because the drugs were not effective. Due to a lack of progress in the field, a couple large pharmaceutical companies, including Pfizer, have just closed their neurology-related research programs.

 (Christopher Rowland, Washington Post)

Trump administration halts fetal-tissue research by government scientists

The Trump administration has announced that government scientists will stop using human fetal tissue for research and is placing new limitations on researchers in academic settings who use federal funding from the NIH.

It is not entirely known how many research projects will be affected by the new regulations. Government scientists will be allowed to continue their current work, but are prohibited from acquiring new tissue samples. Current extramural research at universities and privately funded work can continue but any new grant proposals or renewals of existing projects must be approved by an ethics advisory board that will be formed.

In addition to halting government fetal tissue research, the administration has decided to cancel an ongoing HIV research contract with the University of California San Francisco, effectively ending a 30-year partnership. The project involves using fetal tissue to develop mouse models with human-like immune systems to develop new HIV therapies.

Use of fetal tissue is essential to for studying certain human biological processes, such as kidney development. Often biomedical research uses mice as substitutes of people, but in this case, murine kidney development is too different from their human counterparts to be of use. Some researchers fear that these new restrictions will set back certain research for years to come. Important areas of research that depend on using fetal tissue including HIV, neurodegeneration, human organ growth and regeneration, Zika (determining how/why the virus affects developing fetuses so severely), and certain types of vaccine development.

POLITICO reports that this decision was made after much debate between the White and the Department of Health and Human Services (HHS), which wanted a less restrictive policy. In a statement released Wednesday, HHS said that “promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” HHS is now reviewing whether sufficient alternatives to human fetal tissue exist and will be supporting the development and validation of these models. However, good alternatives for certain fetal tissue research are elusive and many scientists say that the tissue is essential for some fields.

 (Sara Reardon, Nature)

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June 7, 2019 at 6:11 pm

Science Policy Around the Web – May 10th, 2019

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By: Caroline Duncombe

Image by Steve Buissinne from Pixabay 

Drug prices will soon appear in many TV Ads

When watching an advertisement for a prescription drug on the television, a new addition will be added to that long list of side-effects: the product’s cost. On Wednesday, the health and human services secretary, Alex Azar, announced that the Trump administration will require pharmaceutical companies to state the priceof prescriptions in television advertisements in “legible” text, similar to the current standard of side effects. This policy will only apply to drugs whose whole-sale-price exceeds $35 per month.

            Such a change in policy has received substantial pushback from the drug industry. They claim that including the list price would confuse consumers who would potentially pay a different amount post-insurance (that is if you have insurance).  In addition, drug companies claim that such a requirement infringed on the companies’ First Amendment Rights. One of the driving forces behind the new policy change are the patient advocacy groups, who have pointed out that televised drug ads direct consumers to the higher priced medications.  The hope of such a policy is to potentially incentivize drug companies to lower their prices. Mr. Azar in a statement points out “If you’re ashamed of your drug prices, change your drug prices.” 

(Glenn Thrush and Katie Thomas, NYT)


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Written by sciencepolicyforall

May 10, 2019 at 3:07 pm