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Posts Tagged ‘FDA

Science Policy Around the Web – May 29, 2018

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By: Cindo O. Nicholson, Ph.D.

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source: pixabay

Biohacking

As D.I.Y. gene editing gains popularity, ‘Someone is going to get hurt’

The tools to delve into gene editing and engineering as a hobby has become more accessible to the public. This can be attributed to the necessary equipment becoming cheaper and the widely-shared expertise in molecular biology techniques like polymerase chain reactions (PCR), DNA restriction mapping, and the new craze CRISPR-Cas9 gene editing. All of this has resulted in the growth of a Biohacking community, i.e. a community of citizen scientists with a shared interest in do-it-yourself genetic engineering projects.

Though members of the Biohacking community share the belief that there should be open-access to genetic engineering technology, there are those that believe that there is the potential for something catastrophic to occur. The biggest fear is that someone will develop and unleash a fast-spreading, rapidly-mutating, and lethal biological agent. The knowledge to make an infectious virus starting with DNA fragments that are pasted together have been published by the open-access journal PLOS One. However, it should be noted that the same knowledge could be used to engineer life-saving vaccines from synthesized DNA fragments instead of extracting and passaging infectious agents from infected tissue. Nevertheless, the question becomes how are U.S. authorities regulating the use of gene-editing technologies by individuals that are not federally funded?

There are currently multiple agencies responsible for regulating various types of research, and would be responsible for mandating the ethical use of gene-editing technologies by labs funded by their grants. However, not all scientific endeavors rely on government funding. In 2013 there was a public crowdfunding campaign through Kickstarter that raised almost half a million dollars for the engineering of a glowing plant. There have been instances of the F.B.I. reaching out to some “whitehat” biohacking labs and many of these biohacking labs have guidelines that must be adhered to by members or risk being kicked out. However, once kicked out an individual is still free to continue their activities on their own and in secret. With no real way to keep track of the unregulated use of synthetic biology, the U.S. and the world is vulnerable to those who would nefariously use these technologies.

(Emily Baumgaertner, The New York Times)

Food Science

As  lab grown meat advances the US calls for regulation

The regulation of lab-grown meat (also known as “clean meat”) is getting serious consideration by the U.S. House of Representatives. A draft spending bill from the House appropriations panel includes a statement instructing the U.S. Department of Agriculture (USDA) to issue rules on the manufacturing and labeling of lab-grown meats. Lab-grown meat is made from cells taken from live animals like poultry or cattle that is grown into muscle tissue that can be pressed into burger patties or breaded to make nuggets. Advocates of lab-grown meat state that among its benefits are sparing the lives of animals, and its environmental friendliness since lab-grown meat does not generate greenhouse gases like methane and requires less land.

The impending arrival of these lab-grown meat on the market brings to the fore a few questions such as what actually counts as meat, and is it the responsibility of the USDA or is it the FDAs (Food & Drug Administration’s) for regulating these products. Lab-grown meats are made from the cells of animals and as such are more similar to the cell-based products already regulated by the FDA. In fact, inspecting the cell culture facilities where lab-grown meat is made would lie in the realm of expertise of FDA inspectors. By contrast, USDA inspectors are more familiar with inspecting animal slaughter houses.

Some argue that the proposal for the USDA to regulate cellular agriculture is premature because of insufficient knowledge on the strengths and weaknesses of this method of food production. Others believe that using a spending bill to mandate agencies to come up with new regulations is wrong, especially without input from the small businesses that will be regulated.

This debate about who should, and how to regulate the marketing of lab-grown meats is another example of regulation lagging behind innovation. Why is this frequently the case? The first lab grown beef patty to be taste-tested was in 2013, which means there was at least 5 years to preemptively brainstorm how to regulate, decide which federal agency is best suited to issue rules, and come up with language necessary for a proposal.

(Kelly Servick, Science Magazine News)

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May 29, 2018 at 11:11 am

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Science Policy Around the Web – April 3, 2018

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By: Allison Dennis, B.S.

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source: pixabay

Gene Editing

CRISPR’d Food, Coming Soon to a Supermarket Near You

The United States Department of Agriculture has given a green light to plant breeders to use gene-editing technology to produce plant varieties that could have been made the old fashioned way. Traditionally, simple changes in genes have been cultivated in crops through selective breeding over generations, which relies on the naturally occurring mutations in the genome to produce new traits. In more recent history, would-be crop innovators rapidly introduced DNA changes to crop genes through mutagens such as radiation, vastly increasing the chances of producing a desirable genetic change in the next generation.

The first product of the gene-editing tool CRISPR-Cas9 to officially go unregulated was a variety of white button mushrooms whose genome was edited to resist browning. The mushroom was engineered by making a small deletion in its polyphenol oxidase gene, preventing the organism from making the enzyme that interacts with oxygen in the air to form melanins, think of that green bowl of guacamole on your counter slowly turning brown. Since this process did not introduce any new genetic material, the USDA ruled that it would not be regulated.

The USDA and FDA are currently drafting policy to oversee whether foods derived by this impossibly-sped-up-but-otherwise-natural method of crop development will need to be specifically labeled to inform the consumer. However US Secretary of Agriculture Sonny Perdue has made clear that under his direction the “USDA seeks to allow innovation when there is no risk present.”

(Megan Molteni, Wired)

 

Personalized Medicine

Anyone Can Now Take This Breast Cancer Gene Test, But It Probably Won’t Tell You Much

The personalized DNA testing company, 23andMe has had mixed success seeking FDA approval, but may have taken a step closer medical validity this month. The FDA has approved their direct-to-consumer genetic test which can identify three variants of the BRCA1 and BRCA2 genes which are associated with an increase in the risk of developing breast and ovarian cancer. From the comfort of their home, curious patients can spit in a tube that comes at a $199 price tag to learn their result on a panel of FDA approved Genetic Health Risk reports. However, the real value of such diagnostic tests, remains a point of debate.

Because the test will only capture a subset of the known genetic markers for cancer risk, 23andMe stresses that a negative result “cannot rule out your chances of getting cancer.” In fact, most women who are diagnosed with breast or ovarian cancer have no known genetic factors. Those who receive a positive test are still advised to validate their results and seek counseling from a medical professional. The company has conceded the value for such direct-to-consumer genetic tests may be the simple act of raising awareness and inspiring them to take a more proactive role in their healthcare.

(Christie Aschwanden, FiveThirtyEight)

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April 3, 2018 at 11:47 pm

Science Policy Around the Web – March 27, 2018

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By: Patrick Wright, Ph.D

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source: pxhere

Right to Try Drug Access

Why Can’t Dying Patients Get the Drugs They Want?

The United States House of Representatives passed “Right to Try” legislation last week (HR 5247, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018”), which allows terminally ill patients access to experimental drugs that are only required to have completed Phase 1 of a clinical trial, bypassing approval of the Food and Drug Administration (FDA). These patients are those with life-threatening illnesses who have exhausted approved treatment options and are not eligible to participate in a clinical trial (e.g. due to not meeting inclusion criteria) designed to evaluate the desired drug. However, this access still requires cooperation and permission from the drug companies themselves. Hesitation on the side of these companies can be rooted in the potential risk of jeopardizing ongoing clinical trials and the long process of bringing a drug to market. Furthermore, drug companies often do not have a sufficient extra supply of a product to provide to patients. The logistics of granting access could slow efforts to get the drug approved. Opponents of this legislation cite patient safety concerns and the failure to address the fundamental issue of pharmaceutical company denial of access as the most significant problems that still must be addressed.

Some companies acknowledge the importance of FDA oversight and would continue to seek FDA permission even if a Right-to-Try bill becomes law. Dr. Joanne Waldstreicher, the Chief Medical Officer of Johnson & Johnson, said “In our view, the FDA plays a really important role.” It has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.” The legislation includes language that could potentially encourage companies to participate, including preventing the FDA from considering the experiences of patients using the drug when approving drugs. The FDA itself already approves 99 percent of applications to its expanded access program for access to investigational drugs for patients facing serious illnesses.

The Right to Try campaign was initiated by the Goldwater Institute, a libertarian, free-market public policy research and litigation organization, and championed by Vice President Mike Pence. Currently, Right to Try legislation has been enacted by 38 states. Victor Riches, president and Chief Executive Officer of the Goldwater Institute said the passing of this bill “is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first.”

In August 2017, the United States Senate unanimously also passed a Right to Try bill (S 204); notably, it was passed under pressure by Ron Johnson (R-WI) who threatened to hold up a five-year reauthorization of FDA user fee programs if he did not get a vote on the bill. However, the narrower House bill has key differences compared to the Senate version, with House Energy and Commerce Committee Chairman Greg Walden (R-OR), along with FDA Commissioner Scott Gottlieb and other interest groups, having specified additional provisions including limiting the types of patients who can access the pathway and giving the FDA more information regarding the use of the pathway. Because the House bill differs from the earlier Senate bill, the Senate must vote on this revised version. Last week, Senator Minority Leader Chuck Schumer (D-NY) blocked Ron Johnson’s attempt to secure unanimous consent in the Senate to pass the House version of the bill. Senator Schumer stated that the Senate had already passed its version and that he wanted to work on a compromise bill.

(Katie Thomas, The New York Times)

Animal Welfare

Congress Orders USDA to Restore Transparency, Completeness, to Animal Welfare Reports

The U.S. Department of Agriculture (USDA) blacked out a public database containing animal welfare inspection reports and records of enforcement actions that the USDA carried out against violations of the Animal Welfare Act in early 2017. The records were often later reposted after varying levels of redaction, eliciting resistance and objection from proponents of animal research and animal welfare activist groups. Last week, Congress released a report that accompanied the USDA’s 2018 spending bill. It stated that these redactions and the obfuscation in accessing USDA information on inspections and their subsequent enforcement violates previous congressional direction and that “the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws.”

On the same day that the report was released, the Humane Society of the United States (HSUS) filed a lawsuit against the Animal and Plant Health Inspection Service (APHIS), the USDA entity responsible for conducting animal welfare inspections. HSUS had requested documentation (e.g. inspection reports) for three puppy breeding facilities (“puppy mills”) via the Freedom of Information Act (FOIA) and were, in response, provided reports by APHIS with significant contents redacted. The USDA’s FOIA office wrote that because the requested reports were about businesses that operated out of an individual’s private home, they could not be disclosed without that person’s consent. This is not the first lawsuit in response to the blackout that has been filed by animal welfare groups against the USDA. The Animal Legal Defense Fund as part of a coalition with other animal activist organizations (Stop Animal Exploitation Now, Companion Animal Protection Society, and Animal Folks) previously filed a lawsuit in February 2017 against the USDA’s handling of inspection report transparency and availability (Animal Legal Defense Fund v United States Department of Agriculture) that was dismissed by federal Judge William H. Orrick on the grounds that FOIA provides an “adequate, alternate remedy”. The coalition has since appealed the decision.

To explicitly describe the approach and process underlying the blackout and redactions, APHIS states on its website: “APHIS, during the past year, has conducted a comprehensive review of the information it posts on its website for the general public to view. To conduct the review, the entire agency search tool database, along with additional documents, was taken off line. As a result of this review, APHIS has removed certain personal information from APHIS’ website involving the Horse Protection Act and the Animal Welfare Act. APHIS recently reposted certain inspection reports and research facility annual reports that were determined to be appropriate for reposting.” It also states “The agency will continue to review records and determine which information is appropriate for reposting. Those seeking information from APHIS regarding inspection reports not currently posted to the website, regulatory correspondence, and enforcement related matters may submit FOIA requests for that information.”

It appears that the language in the new Congressional report, part of the new omnibus spending bill that was just approved by Congress and President Donald Trump, has support among the animal welfare community. Cathy Liss, president of the Animal Welfare Institute, based out of Washington, D.C., stated “The Animal Welfare Institute applauds Congress for forcing USDA to lift its veil of secrecy.” Similarly, Kathleen Conlee, vice president for animal research at HSUS said she is “very pleased” with the report and that the “HSUS has been working closely with Members of Congress over the past year to address USDA’s outrageous purge and redaction of these vital documents.”

(Meredith Wadman, Science)

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March 27, 2018 at 12:27 pm

Ask your doctor: This drug might be right for you

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By: Jennifer Patterson-West, Ph.D.

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source: Mike Licht via flickr

Direct-to-consumer advertising (DTCA) of prescription drugs is currently only legal in the United States and New Zealand.  In the United States, DTC advertising is regulated by the Office of Prescription Drug Promotion (OPDP) within the Food and Drug Administration (FDA).  The stated mission of the OPDP is to “protect public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.”

From patients to consumers

The first DTCA was a print ad for Pneumovax vaccine in 1981. A couple years later, the first broadcast advertisement aired for Rufen, a prescription brand ibuprofen.  In 1985, in response to initial DTCA, the FDA published a notice claiming jurisdiction over the regulation of DTCA. The FDA’s authority would hold DCTA to the same standards as previously established for advertisements to health care providers.  These standards required that advertisement contain a “fair balance” and “brief summary” that notes every risk described on the drug’s label.  Following the release of these standards, DTC print advertisements became prevalent with annual DTCA spending rising from $12 million (1980) to $340 million (1995).

The FDA loosened standards in 1997 by replacing the requirement of a “brief summary” with a “major statement” that only requires inclusion of the major risks associated with a drug and an adequate provision for consumers to obtain additional drug information, such as a toll-free number or website.  By no longer requiring drug companies to buy enough air-time to read the fine print, these new standards removed the fiscal constraint previously restricting the use of broadcast DTCA.  In fact, by the following year, annual spending on DTCAs increased to $1.2 billion annually and peaked at $5 billion in the mid-2000s.  It has been estimated, that on average, Americans now watch 9 drug advertisements per day, which equates to approximately 16 hours per year.  This level of contact far exceeds the amount of time patients typically spend with medical professionals.

Persuasive or informative? Are DTCAs truthful, balanced, and accurate?

Surprisingly, the debate around DTCA is balanced with respect to advocates and critics with considerable evidence supporting both positions.  However, the focus of those on the two sides of the debate differ considerable.  Advocates focus on the benefits associated with DTCA, whereas critics highlight examples of DTCA that are in direct subversion of established regulations and the stated mission of OPDP.

Advocates assert that DTCA empowers consumers by informing them about different treatment options, reduces associated stigmas, prompts dialogue with health care providers, and improves patient compliance.  Improved dialogue with healthcare providers is supported by a 2004 FDA survey in which 73% of physicians reported that they thought DTC advertisements helped patients ask more thoughtful question.  In the same survey, 77% of physicians declared that DTCA improved awareness of new drugs, whereas 33% of physicians agreed that the advertisements increased patient adherence.  In addition to these advantages, proponents suggest that DTCA drives competition, thereby reducing prescription costs.  However, no verifiable evidence is available to support this claim.

In contrast, critics proclaim that DTCA misinforms patients, medicalizes natural conditions, and strains patient-physician relationships.  In the same survey mentioned above, 60% of physicians believed that DTCA did not provide sufficient information regarding risks and 58% of physicians thought DTCA inspired patients to overestimate the efficacy of a particular drug.  These sentiments indicate that advertisements did not adequately communicate a balance of risk and benefit related information.  A recent study by Klara et al. found that 13% of ads within their study section suggested off-label uses, which are prohibited under current regulations. None of the evaluated ads quantified risk.  Another major critisim, is the medicalization of normal conditions such as hormonal changes associated with menopause or variability in sexual performance.  Proponents claim that medicalization heightens patient discontent with “symptoms” ultimately promoting the over utilization of pharmaceutical interventions that consequently contributes to rising medical costs.  Manufacturing of disease states is another example of advertisement practices that are in direct opposition of the stated OCPC mission which promotes the communication of truthful and accurate information.

The argument outlined by critics is likely contributing to the overall sentiment of physicians toward DTCA despite stated benefits.  In a 2013 survey by CMI/Compas that probed the opinion of physicians with respect to the current levels of DTCA, 52.9% supported a scale back, 18.3% felt it should be eliminated, 26% indicated that it should continue as is, and only 2.9% agreed with the expansion.

Maximizing benefit, while limiting risk

The unfavorable effects of DTCA can be lessened by the strict enforcement of current regulations and a careful assessment of advertisement strategies that interfere with truthful, balanced, and accurate communication of drug infomation.  However, since 2010, there has been a sharp decline in enforcement activity by the OPDP.  This decline follows the 2011 Supreme court ruling in Sorell v. IMS Health, which established that pharmaceutical marketing is protected under the Freedom of Speech Clause of the First Amendent.

Despite extensive critisms, it is unlikely that broad restrictions will be implemented in light of this and other juridical rulings that favor increased protection of commercial speech.  Additional measures have been proposed to minimize the risks associated with DTCA and maximize the benefits of engaging and educating consumers.  These include: (1) restricting advertisement of new drugs for a set number of years following approval, (2) pre-clearance of DTCA materials by the FDA or an unbiased entity, (3) mandating that all materials be presented at an 8th grade literacy level, and (4) requiring the inclusion of quantitative information regarding both the potential benefits and risks.  However, additional guidelines that focus on restricting or controlling the messaging of DTCA are unlikely to be upheld when they are challenged in court, due to the recently set precident.

An alternative approach to restrict DTCA has been focused on increasing the associated financial burden.  In 2002, U.S. Representative Jerrord Nadler (D-NY) introduced a measured called Say No To Drug Ads Act that would eliminate the use of tax deductions by pharmaceutical companies for DTCA costs.  Ultimately, this bill was not passed.  Recently, U.S. Representative Rosa DeLauro (D-CT) introduced the Responsibility in Drug Advertisement Act with a similar aim.  Although financial restrictions of DTCA are not in opposition to the constitution or current juridical rulings, this bill is also not expected to progress due to the current political climate.

Based on established precedents within the courts and the current political climate, mitigating the risk associated with DTCA may fall to consumer advocate groups or a public education campaign that informs patients about how to properly evaluate the risks and benefits of prescription drugs.  The success of FDA’s “The real cost” campaign emphasizes the potential benefit of public health campaigns and their impact on consumer behavior.

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March 26, 2018 at 11:20 am

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Science Policy Around the Web – February 13, 2018

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By: Saurav Seshadri, PhD

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source: pixabay

Experimental drugs

Trump Endorses “Right to Try” for Terminally Ill Patients

Proponents of the ‘right to try’ received some encouragement from President Trump’s recent State of the Union address, in which he announced his support for such legislation at the federal level.  Right to Try laws are designed to allow terminally ill patients to obtain unapproved but possibly lifesaving drugs directly from pharmaceutical companies, without involving the FDA.  While such laws already exist in 38 states, they are currently superseded by the Food, Drug, and Cosmetic Act; a bill that would eliminate this legal conflict was passed by the Senate last August, but has yet to be approved by the House of Representatives.

In general, Right to Try laws permit terminal patients, with their informed consent, to access investigational treatments if recommended by a physician.  However, they do not mandate that the manufacturer provide the drug or that insurance cover it, and in some cases, they absolve drugmakers and physicians from liability for adverse outcomes.  In addition, the FDA already offers a path to treatment for terminal patients under its ‘expanded access’ program, in which patients are treated as clinical trial participants and their doctor’s office becomes a satellite site, with appropriate regulatory oversight.  Opponents of Right to Try legislation, including FDA Commissioner Scott Gottlieb, argue that bypassing such oversight would critically undermine the clinical trial process (for example, a patient death from a drug obtained under a Right to Try law would not factor into the FDA’s consideration of that drug for approval).  They also suggest that these laws provide false hope for desperate patients – experimental drugs need only clear the safety phase of FDA trials, meaning no data exists on their efficacy – and open patients up to risks of physical harm and medical fraud.

Despite these concerns, Right to Try laws have gained momentum on the strength of anecdotal success stories, and politicians’ unwillingness to appear heartless towards patients suffering from terminal diseases.  Yet in reality, without securing financial support for patients, these laws are likely to result in some patients going bankrupt. Without requiring that treatments be demonstrated to be beneficial and at least safe, these laws are likely to result in patients pursuing ineffective treatments, while reducing their quality of life by enduring side effects, risking complications, and forgoing hospice care.  The future of Right to Try legislation may be influenced by new Health and Homeland Security Secretary (and former Eli Lilly executive) Alex Azar, who seems likely to support Trump’s agenda, though he didn’t mention the right to try in his response to the State of the Union address.  Ideally, the final bill will prioritize the existing drug review process, ensuring safety for the majority of patients while still providing hope for the sickest.

(Ike Swetlitz, STAT news)

Chemical safety

The truth about glyphosate may be getting lost in the weeds

The World Health Organization (WHO) kicked off a massive controversy in 2015 with its report labeling glyphosate, a component of an herbicide marketed by Monsanto, as ‘probably carcinogenic to humans’.  The report has faced stiff opposition from Republican Representatives on the US House Science, Space, and Technology Committee, largely fueled by a pair of Reuters reports suggesting that key data was suppressed by the WHO to support its conclusion.  Now Dr. Christopher Wild, Director of the group that conducted the research (the IARC, International Agency for Research on Cancer) has sent a detailed response to the Committee to rebut these criticisms and defend its original finding.

The response, which was presented at a recent Committee hearing by Democratic Representative Suzanne Bonamici, specifically addresses two issues raised by Reuters.  First, that a senior scientist failed to disclose data that would have exonerated glyphosate: the data was unpublished and therefore didn’t meet IARC’s criteria for consideration.  Second, that the published version of the report had several changes from an earlier draft, all of which involved deleting or revising statements that cast doubt on glyphosate’s link to cancer.  Dr. Wild claims that most of these changes were related to a single review article, whose conclusions were reconsidered when it was found to have been ghostwritten by a Monsanto scientist, and that its drafts are works in progress and therefore confidential.  Still, the response doesn’t explain the IARC’s discrepancy with other regulatory agencies: the European Food Safety Authority (EFSA) and US Environmental Protection Agency (EPA) have both found glyphosate to be safe, and claim their review processes are more transparent than the IARC’s.

The IARC’s stance on glyphosate puts it in a delicate position with the US government, from which it receives ‘valuable support’, especially as the topic becomes more partisan.  Republican lawmakers have already threatened to pull funding to the IARC, ostensibly over its refusal to provide a witness for the hearing (Dr. Wild invited them to visit his facility in France instead).  On the other side, the EPA’s assessment has been called into question by the discovery that an EPA official may have colluded with Monsanto to ‘kill’ investigation into glyphosate, leading Democratic Representative Ted Lieu to request a probe into the issue.  In the midst of a heated debate on climate change, the glyphosate story may initially seem to be another case of Republicans denying science to fight regulations and side with big business; however, the reality may be more complicated.  A recent protest in Paris by farmers, opposed to a proposed ban on glyphosate, highlights how those most affected by such policies must balance their economic stability against potential health risks.  Ultimately, though lawmakers may earn political points by siding with these individuals, if the price is discrediting accurate science and eroding public trust in regulatory agencies, no one wins.

(Corbin Hiar, E&E News)

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February 13, 2018 at 6:01 pm

Science Policy Around the Web – January 19, 2018

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By: Allison Dennis B.S.

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source: pixabay

Emergency Unpreparedness

IV bag shortage has hospitals scrambling to treat flu

While other hospital activities may put a predictable strain on medical supplies, the sudden onset of a particularly bad flu season has left hospitals strapped for the basic medical staple, IV bags. Intravenous (IV) therapy delivers liquids directly to the vein and is made possible by prepackaged sterile bags loaded with saline, a mix of water, salt, sugar, electrolytes, and vitamins that match what naturally exists in the body. By matching the natural composition of blood, these fluids are able to help the body rapidly return to normal after dehydration and can efficiently deliver drugs. Severe dehydration is a common side effect of flu, as one of the body’s first line of defense is to develop a fever, a process that expends a lot of water and oxygen. Additional symptoms may leave flu-sufferers uninterested or unable to drink the water they need. For patients ill enough to seek treatment at the hospital, IV therapy is often required to rapidly rehydrate their bodies and can be used simultaneously to deliver antivirals.

IV bags have been continuously in short supply in the US since 2014. Reasons for this shortage seem to stem from the complexities of safely manufacturing saline, a 10-day process that reportedly requires 29 steps, and the insatiable demand, 740 IV bags are estimated to be used each minute in the US. Production of IV drugs and saline is more tightly regulated by the FDA than other drugs because they are injected directly into the blood stream. Even the smallest contamination can result in a widespread blood infection.

In recent months, the shortage has been heightened by the coalescing of two closely monitored seasons, flu and hurricane. Half of the IV bags used in the US are manufactured in Puerto Rico, which was devastated by hurricane damage early this fall. IV bag producers are slowly returning to their pre-storm levels of production, but ongoing power outages are continuing to cause disruption. To try to alleviate this burden, the FDA has granted additional companies permission to begin manufacturing and selling the bags that are in short supply. To help hospitals struggling to meet the constant demand for IV bags, the FDA is temporarily permitting hospitals to import sterile saline from overseas.

In some cases, care providers are able to substitute pills for drugs usually administered intravenously. In others, providers may choose to administer drugs through an I.V. push, directly injecting them into the vein, a method that can be both painful and time consuming. But when it comes to treating the severe dehydration that can result when the body battle the flu, intravenous rehydration is often the only appropriate treatment.

(Linda Johnson, Associated Press)

Technology

After years of avoidance, Department of Energy joins quest to develop quantum computers

Quantum computing promises to revolutionize the way we solve complex problems through computation. While the hardware needed to make this a reality exists, software developers and thinkers are struggling to catch up. Conventional computers use bits, either 0 or 1, to create logic in a language the computer can understand. Quantum computers would expand this language to capture the ability of subatomic particles to exist in more than one state at a time. Instead of bits, these computers would use qubits, or quantum bits, allowing more information to be stored without using more energy.

But to think of quantum computing as just a more powerful conventional computer is off base. The types of problems these computers will solve will be fundamentally different. By using the properties of quantum interference, computer scientists are hoping to develop algorithms that would allow incorrect-solutions or redundant information to cancel each other out. These properties would allow quantum computers to perform incredibly complicated calculations while still delivering an interpretable result. These computers may prove an asset to modeling quantum processes themselves, a task conventional computers struggle with. On the to-do list are calculating molecular energies, modeling catalysis by enzymes, designing novel materials at the atomic level.

Overtime, programming languages evolved to allow developers to write code without constantly needing to know how computers would physically implement that code. However, learning how to use quantum hardware to perform what will be new types of computation is requiring physicists, computer scientists, and researchers to start from the beginning again. To foster collaboration, the Department of Energy has set up quantum computing testbeds, places where hardware designers and scientists can work together to simultaneously shape the computational revolution to come.

(Adrian Cho, Science)

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January 19, 2018 at 7:11 pm

FDA stem cell therapy crackdown: a stem-free clinic

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By: Belinda Hauser, Ph.D.

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source: pixabay

The building blocks of life are stem cells, they don’t kill or cure anything, but they promote regeneration. Stem cells are classically defined as an undifferentiated cell capable of giving rise to more stem cells or differentiating into any cell type. Stem cells have given scientists insight into understanding how cells function and dysfunction in development. Moreover, research in stem cell development has lead to promising treatment possibilities; it is believed that stem cells have the potential to repair or replace damage caused by age, injury or disease. However, stem cell therapies have been controversial, arising from the practice of isolating and culturing stem cell derived from human embryos, and later, introducing pluripotent stem cells from previously differentiated cell types. This controversy is entrenched in both political and ethical debates, broadly affecting the regulation of cord blood harvesting, human cloning and clinical trials.

Today, common stem cell therapy uses include blood transplants or bone marrow transplants. The Food and Drug Administration (FDA) has only approved hematopoietic progenitor cells, derived from umbilical cord blood, for use in the United States. Harvesting of cord blood is considered safe for the mother and baby since the blood is collected after birth. Stem cells collected from the blood of the cut cord are used to treat a variety of diseases including blood cancers such as leukemia, and lymphomas, and blood diseases of the immune system. Given the scarcity of approved options, patients desperately seeking therapy may turn to treatments that are illegal and potentially harmful. The FDA has gone to great lengths to evaluate the potential risk associated with new and current products through both animal and human studies in order to ensure safety in the use of biological products. Thereby, to determine the effectiveness and safety of new investigative products, well-controlled human studies must be designed and executed. This attention is applied to all clinical trials and is well documented. For example, the federal government requires all clinical trials to be cited and it is standard protocol for the National Institutes of Health (NIH) to list all clinical trials being conducted via Clinicaltrials.gov. This promotes awareness and gives consumers an opportunity to be well informed of all trials being conducted.

Preceding the FDA’s goal to develop and license stem cell therapies for patients and prevent consumer exploitation is their concern for consumer safety and education. In March 2017, the FDA provided materials to clarify the benefits and risks of stem cell therapies. They warned that when injected, unproven stem cell treatments present the risk of mobility of implanted cells, i.e. metastasis, risk of excessive proliferation, i.e. tumor growth, contamination, stem cell failure, or reaction of the injection site. Therefore, new investigative products must go through a rigorous protocol to determine their effectiveness and safety in well-controlled human studies.

In August 2017, the FDA cracked down on unscrupulous stem cell clinics, announcing increased enforcement of regulations and oversight of stem cells clinics across the country. For example, the FDA seized five vials of (live) smallpox virus vaccine from the California stem cell treatment centers in Rancho Mirage and Beverly Hills, California.  A Florida clinic, now called U.S. Stem Cell Clinic of Sunrise, Florida, caught the attention of the FDA after stem cell treatments it delivered to women with macular degeneration, an eye disease, caused permanent damage. Staff member used stem cells from fat isolated from each patient’s stomach and then injected cells into their eyes. A common practice of clinical trials is to pay human subject-volunteers to participate in studies. However, to receive this unproven treatment patients were required to pay $5,000 to receive the stem cell injections. Permitting patients to pay for participation is a topic of ethical debate for even the most scrupulously designed trials. The FDA issued a notice warning U.S. Stem Cell Clinic for marketing products without FDA approval and condemning their exploitation of consumers. An inspection performed  by FDA investigators found evidence of significant deviations from good manufacturing practices in manufacturing of at least 256 lots of stem cell products produced by the clinic. In an attempt to impede the investigation, the U.S. Stem Cell Clinic attempted to refused access of the FDA investigators to the employees of the clinic.  Ultimately, the clinic was cited for failure to establish appropriate written procedures to prevent contamination, risking infection of human subjects. It is required that U.S. Stem Cell Clinic comply and correct the failures stated in the warning letter. If the clinic fails to address the outlined issues, actions will be taken by the FDA, these include seizure, injunction and or prosecution.  Moreover, U.S. Stem Cell Clinic  administered the product both intravenously and directly into the spinal cord of patients hoping to treat a number of serious diseases (Parkinson’s disease, amyotrophic lateral sclerosis (ALS) heart disease, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD), all without FDA review or approval. In fact the FDA has not approved any biological products manufactured by U.S. Stem Cell Clinic for any use.

Overall, the challenge of regulation and compliance continues to loom over all stem cell clinics in the U.S.; however, the FDA is dedicated to enforcing continuous regulation, while educating and protecting U.S. consumers. The building blocks of life are stem cells, manipulated properly, they have the ability to treat disease without posing unacceptable risk. Safely figuring out how will take time.

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Written by sciencepolicyforall

January 17, 2018 at 11:43 am