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Posts Tagged ‘depression

Science Policy Around the Web – March 22, 2019

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By: Caroline Duncombe.

Image by 1388843 from Pixabay

FDA Approves First Drug for Postpartum Depression

In the USA, about 400,000 women develop post-partum depression (PPD) each year. Up until Tuesday, there was no FDA approved pharmaceutical treatment designed specifically for PPD. In attempts to alleviate PPD episodes, doctors previously prescribed drugs designed for general depression, such as selective serotonin-reuptake inhibitors (SSRIs). Such drugs were not specifically designed for PPD which involves distinct mechanisms of action that are directly related to pregnancy and childbirth. SSRIs often take months to achieve remission or adequate response, if ever. Such deficiencies are supposedly addressed by the new drug, brexanolone, marketed at Zulresso, which was designed specifically to address post-partum depression and acheives rapid onset of response alleviation.

Although brexanolone is the first FDA approved treatment for PPD, the long infusion period, the high cost of the treatment, and lacking evidence on the effectiveness of this treatment demonstrate the long road ahead before PPD treatment is ubiquitous and operational. The Brexanolone treatment is not simple: it involves a continuous intravenous (IV) infusion over the course of 60 hours. Due to the risk of the treatment, patients will be required to stay within an in-patient unit of a hospital for those 2.5 days. Considering that the treatment alone cost $34,000 for a full course, the additional cost of in-patient care would make this treatment inaccessible for many who demonstrate severe PPD. Some insurance providers may decide to cover the treatment cost, but for those who do not have insurance or are denied coverage this treatment will be inaccessible.

Additionally, the FDA approval application was largely informed by a flawed phase III clinical trial funded by Sage Pharmaceuticals, the producer of Zulresso. The trial only included 246 participants, which is a relatively small sample size for a phase III trial. A large sample size is important to providing a conclusive clinical trial result on drug side-effects. This is crucial because if a severe side effect is found within 1 in every 1000 participants (or 1 in 10,000, etc) that level of risk would most likely not be detected within a trial only enrolling 246 participants. Additionally, this specific trial compared participants to a placebo, and not existing treatment standards of anti-depressants like SSRIs. The trail also only assessed the women volunteers over a 30-day follow-up period post infusion, which means that the lasting effects beyond the first month of Brexanolone are still unknown.

Further research on Brexanolone will be necessary to definitively assess its impact of reducing PPD. At this moment Sage Therapeutics is also implementing a phase III trialon a PPD treatment drug that is structurally similar to Bexanolone but is capable of being administered via a pill. If successful, such a drug could make treatment for post-partum depression more accessible to all. 

(Pam Belluck, New York Times)



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March 22, 2019 at 5:24 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 – April 10, 2018

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By: Allison Dennis B.S.

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source: pixabay

Mental Health

Many People Taking Antidepressants Discover They Cannot Quit

15 million American adults have taken antidepressants for a period longer than five years, in spite of the fact that these drugs were originally approved for short-term treatment, lasting less than nine months. Many doctors agree that a lifetime prescription may be necessary for the treatment of some patients. However, many are concerned that some patients may simply be accepting long-term use of antidepressants when faced with the challenge of stopping.

Surveys have shown that choosing to stop long-term medications is not a straightforward process with many patients reporting withdrawal effects. Some antidepressants take weeks to break down and leave the body, and their absence can induce feelings of anxiety, insomnia, nausea, “brain zaps,” and even depression itself. Antidepressants are one of the most frequently prescribed therapeutics by physicians, yet the drugs’ labels do not outline how to end a prescription safely. Patients may have to turn to online resources, including  The Withdrawal Project, which provides a community based approach to provide support, but whose writers are self-described as “laypeople who have direct personal experience or who have supported someone else in the process of reducing or tapering off psychiatric medication,” but are not medical professionals.

The benefits of antidepressants in the treatment of depression is undeniable, leaving government regulators cautious about limiting their availability. Antidepressant manufacturers appear unwilling to dive into research characterizing the discontinuation syndrome experienced when patients try to stop, feeling their efforts to demonstrate the drugs are safe and effective is sufficient. Academic and clinical researchers have occasionally tackled the issue, but few studies have looked at the barriers facing open-ended antidepressant prescription holders.

(Benedict Carey and Robert Gebeloff, The New York Times)

Alzheimer’s Disease

Scientists Push Plan To Change How Researchers Define Alzheimer’s

Currently, the 5.7 million Americans living with Alzheimer’s are identified through a panel of symptoms including memory problems or fuzzy thinking. However these symptoms are the product of biological changes scientists feel may be an earlier and more accurate marker of disease. On the biological level, Alzheimer’s can be characterized by the accumulation of several characteristic structures in brain tissue including, plaques, abnormal clusters of protein that accumulate between nerve cells, tangles, twisted fibers that form inside dying cells, and the build up of glial cells, which ordinarily work to clear debris from the brain. It is unclear if these changes are driving the widespread disconnection and destruction of neurons exhibited in the parts of the brain involved in memory and later in those responsible for language and reasoning in the brains of Alzheimer’s patients or just a byproduct of a yet-to-be-discovered process.

A work group formed by collaborators at the National Institute on Aging and the Alzheimer’s Association are putting forward a research framework which defines Alzheimer’s by the progression of a panel of risk factors, including neuropathology, tangles, plaques, and neurodegeneration. By allowing these biomarkers to fall along a continuum, the group is accommodating the observation that the exhibition of these traits can vary widely between individuals and may not always co-occur with symptoms. Yet the framework is intended to “create a common language with which the research community can test hypotheses about the interactions between Alzheimer’s Disease pathologic processes.”

Although much of the research is preliminary, specialized brain scans and tests of spinal fluid are already being designed to identify these biomarkers directly. The biomarkers included on the continuum can be observed 20-30 years prior to symptoms, fostering the hope that early interventions could be implemented to slow disease progression or even prevent it in the first place.

(Jon Hamilton, NPR)

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April 11, 2018 at 6:11 pm

Science Policy Around the Web – August 15, 2017

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By: Liu-Ya Tang, PhD

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Picture Source: pixabay

Public Health

Obesity and Depression, Entwined or Not?

It might seem that obesity and depression are not related since they are diseases from different parts of the body; however, health care practitioners have observed that these two diseases have a close relationship. The development of obesity and depression can be a vicious cycle, one favoring the other. Extra weight brings anxieties to obese people, which can cause poor self-image and social isolation. These are known contributors to depression. On the other hand, people experiencing depression tend to overeat and avoid exercising. According to the federal Centers for Disease Control and Prevention, about 43 percent of people with depression are obese, compared with 36.5 percent of the general population. People with obesity have a higher risk to develop depression, and vice versa, according to one 2010 study.

Both obesity and depression are chronic diseases that are hard to treat, placing a big burden on the health care system. Obesity rates in the United States are among the highest in the world. Obesity alone costs almost $150 billion per year in direct expenses, and this number is estimated to increase about $1.24 billion each year till the year 2030. The cost of treating depression is even higher, which is more than $200 billion every year. So it is urgent to find ways to treat both diseases more effectively if they are bidirecitonally comorbid.

When depression and obesity coincide, the combination of physical and mental health interventions becomes important, which has been supported by several studies. Researchers from the University of Texas-Southwestern found that patients’ depression were alleviated when they did weekly exercise sessions, which were prescribed by physicians. Another study from Duke University found that the rate of depression in obese women was decreased by 50 percent simply by helping them control their weight. The combinatorial treatment has been adopted. Dr. Sue McElroy, a psychiatrist in Mason, Ohio, screens patients for weight and BMI, and treats obesity and depression together. She tailors her prescription, as some antidepressants can cause weight gain. Her “self-taught” method was welcomed by her patients. However, this is not a general practice in treating patients with both symptoms. To benefit patients’ health and reduce cost for curing obesity and depression, the whole health care system needs a change.

(Shefali Luthra, Kaiser Health News)

 

The ACA

What do people and health-policy experts think about repealing the ACA?

Since March, the Trump administration has strived to repeal and replace the Affordable Care Act (ACA), but the Senate rejected this repeal, as 3 republican senators voted “no” last month. How do people feel about repealing the ACA? What do most people say the Trump administration should do after the Senate failed to repeal? There were two reports about it.

The first one was about a survey conducted Aug. 1-6 by the Kaiser Family Foundation, which capture the opinions of 1,211 adults. Their analysis found that a majority of people (78 percent) think that the government should make the ACA work better. Grouping this majority by Political Party ID, reveales 95 percent are Democrats, 80 percent re independents and 52 percent are Republicans. Even 51 percent of President Trump’s supporters think both parties should work together to improve the health law.

The second report said that a coalition of liberal and conservative health-policy leaders is making suggestions for how to strengthen the existing ACA law, aligned with a favorable view in the public. The nine group members are from think tanks, universities and advocacy groups, who can be influential in health-policy formation of the government. The coalition was founded when it appeared that the Republican-controlled Congress would pass a repeal of the ACA without a replacement plan. It took the group eight months to come up with a five-point set of principles. It says that the government should continue providing subsidies to insurers that extend plans to 7 million lower-income customers and strong incentives for Americans to carry health insurance. The latter will help the cost of expensive care be shared by a stable insurance pool with healthy customers. They also urge the government to bring health plans to about two dozen counties, which would be left providerless in the ACA marketplace for 2018. The group said they intend to present their idea to Republican and Democratic lawmakers. “We are trying to model bipartisanship so incremental steps can be taken,” said by Ron Pollack, chairman emeritus of the liberal consumer-health lobby Families USA.

To prevent the potential collapse of health insurance market, the Senate is planning a bipartisan hearing on health care in September. In the House, a group of around 40 Republicans and Democrats known as the Problem Solvers Caucus aims to making urgent fixes to the ACA law. On September 27th, insurers will sign contracts with the federal government over what insurance plans to sell on the marketplace for 2018, which pushes Congress to come up with a solution before then.

(Phil Galewitz, Kaiser Health News, and Amy Goldstein, The Washington Post)

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August 15, 2017 at 6:27 pm

Science Policy Around the Web – November 21, 2014

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By: Elisavet Serti, PhD

photo credit: danielfoster437 via photopin cc

Drug Policy

Gilead pharma company will cut anti-HepC drug cost for developing countries

US drugmaker Gilead has licensed Sovaldi, its $1000-a-pill Hepatitis C drug to seven India-based drugmakers that will sell cheaper versions of the drug in 91 developing countries. Gilead has been criticized in the recent past because of the very high price of its drug ($84,000 for a complete treatment course), which excludes the majority of chronic HCV patients from receiving state of the art treatment. According to Dr. Hoofnagle, a famous NIH gastroenterologist that contributed to the establishment of the previous standard of care anti HCV treatment, a 12-week treatment course with the new combination pill against Hepatitis C genotype 1, called Harvoni from Gilead (it contains Sovaldi with one more post-anti-viral agent known as Lediparvir) reaches even higher response rates (greater than 93%), but it costs $96,000 and private insurance companies usually refuse to cover this cost. The estimated burden of anti-HepC treatment for the already overburdened US health care system will be at around $100 billion. (Aditya Kalra and Zeba Siddiqui, Reuters and Dr J. Hoofnagle’s lecture in Bethesda on 11/12/2014)

 

Federal Research Funding

The depressing burden of depression

I guess you would all agree that the modern way of life is a major factor for the increase in the cases of depression, which has now been accepted as a medical problem that needs to be treated as early as possible. According to reports, depression causes more disability than any other mental health problem (WHO. 2004) and accounts for mood changes, concentration problems and decrease in workforce productivity. Depression’s annual toll on U.S. businesses is approximately $70 billion in medical expenditures, lost productivity and other costs. Depression accounts for close to $12 billion in lost workdays each year (Wall Street Journal, 2001). Although depression is common, it is often ignored. Depressive disorders affect approximately 6.7 percent of the U.S. population age 18 and older in a given year (Archives of General Psychiatry, 2005 Jun; 62(6): 617-27). Some psychiatrists support that the high levels of undiagnosed or untreated depression would be considered scandalous for a disease such as cancer. It seems that the absence of a crisp diagnosis and the lack of understanding the mechanism of the disease development have held back therapy and research. Genetic studies have failed to define a specific genetic component, several therapeutic clinical trials have failed, and existing treatments need refinement. Redefining research agendas, raising awareness and increasing the funds towards research on depression should be priorities, especially in the era of the “BRAIN Initiative.”   (Heidi Ledford, Nature)

 

Workforce Development

PhDs outside academia: The brave ones who got away

Lots of discussion has been done lately about the future of PhD students and post Docs emerging from universities simply because there are not enough opportunities and funds in the academia to support them. Approximately 20% of Americans with science PhDs were not working in science in 2010 (nsf.gov) and less than 10% of the 86,000 current biology PhD students in the United States will become tenure-track faculty members (go.nature.com/vh1ewm). The paradox is that post Docs that are actually brave enough to accepts the facts and to leave the lab to work elsewhere are judged to have lost their focus or their “scientific drive” or to have been seduced by the dark side. Forcing a highly trained postdoc away from research is a waste of knowledge, time and money; that is why the whole research sector needs to be restructured. Universities and research institutes should stop taking advantage of the “cheap trainees” i.e. PhD students and post Docs, and more permanent research positions should be generated. These permanent employees would cost more but the labs would become smaller and far more efficient. (by Jessica Polska, ascb.org)

 

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Written by sciencepolicyforall

November 21, 2014 at 12:00 pm

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