Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Misinfo About Health Topics is Widespread. NIH is Here to Help: 9 Qs To Help You Make Sense of Health Research

Misinfo About Health Topics is Widespread. NIH is Here to Help: 9 Qs To Help You Make Sense of Health Research | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Almost every day, new findings on medical research are published, some of which may include complementary health approaches.

Research studies about medical treatments and practices published in scientific journals are often the sources of news stories and can be important tools in helping you manage your health.

But finding scientific journal articles, understanding the studies they describe, and interpreting the results can be challenging.

One way to make it easier to understand information you find in a scientific journal is to share the information with your health care providers and get their opinions. Once you understand the basics and terminology of scientific research, you have one more tool to help you make better, informed decisions about your health.
 
Here are 9 questions that can help you make sense of a scientific research article.

Pharma Guy's insight:

Misinformation about health topics is widespread. The need for stronger science literacy efforts is especially clear in the complementary and integrative health space, where many approaches are readily available in the marketplace and are often selected for self-care. Recognition of science literacy gaps and identifying opportunities to fill them, led the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, to conduct a series of conversations with in-house experts across NIH and well as external stakeholders in the field.

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Trump Reportedly Considering New Budget Cuts to "Disembowel" the NIH

Trump Reportedly Considering New Budget Cuts to "Disembowel" the NIH | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Two months ago, the Trump administration unveiled its so-called “skinny budget,” which envisioned cutting funds for the National Institutes of Health by 18 percent, or $5.8 billion (read “Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!”; http://sco.lt/5qbezp). Scientists were appalled. As my colleague Adrienne LaFrance reported, one doctor said that the cuts “would set off a lost generation in American science.”

 

The bulked-up version of the President’s budget for fiscal year 2018, which will be released next week, may not allay those fears. According to two sources within the NIH who were briefed on the issue, the administration may pursue a new strategy in its quest for cuts, by proposing a 10 percent cap on the NIH’s indirect costs—the money it gives to grantees to support administration, equipment, libraries, IT, lighting, heating, electricity, and other overhead.

 

“It’s going to make every single university president across the country call their representative,” says one of the sources, who agreed to speak on condition of anonymity.

 

It’s not surprising that the administration is considering a cap. In the wake of the skinny budget, Secretary of Health and Human Services Tom Price defended the cuts by arguing that indirect costs represented “inefficiencies”—money going towards “something other than the research that’s being done.” As Science reported in March, the NIH doled out $6.4 billion in indirect costs in fiscal year 2016, which was 38 percent of the $16.9 billion it spent directly on research. If the 10 percent ceiling had been installed, indirect costs would have been capped at roughly $1.7 billion, representing a saving of $4.7 billion.

 

“Even if you wanted to do this, you don’t do it in one year,” says Harold Varmus, a Nobel laureate and former NIH director. “It would be a tremendous blow for many of our research institutions and ignores the real cost of doing research. If you really want to disembowel a source of learning and ingenuity in America, this is what you do.”

 

“Instead of having an informed process where they get people together and talk about how to build efficiencies, they’re just backing into the numbers that the President put forward,” says one of the sources at the NIH.

 

Further Reading:

  • “Head of NIH Testifies Before Congress in Support of the Next Generation of Research Scientists”; http://sco.lt/6K4Ecr
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Congress Rebuffs Trump and Gives NIH a $2 Billion Funding Boost - 2018 Funding Still Subject to Massive Cuts

Congress Rebuffs Trump and Gives NIH a $2 Billion Funding Boost - 2018 Funding Still Subject to Massive Cuts | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The National Institutes of Health will get a $2 billion funding boost over the next five months, under a bipartisan spending deal reached late Sunday night in Congress. The agreement marks a sharp rejection of President Trump’s proposal to cut $1.2 billion from the medical research agency in the current fiscal year.

The deal does not address funding for 2018, when Trump has called for a slashing the NIH’s budget by about a fifth, or $5.8 billion.

But it sends a clear signal that lawmakers on both sides of the aisle prioritize funding for medical research and intend to honor the agreements laid out in the 21st Century Cures Act, a bipartisan bill that called for raising NIH funding and speeding approvals of new drugs and medical devices. This will be the second year running that Congress gives a $2 billion funding bump to the agency, which funds medical research across the country.

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Biden Bashes Trump's Proposed "Draconian Cuts" to NIH Funding

Biden Bashes Trump's Proposed "Draconian Cuts" to NIH Funding | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a speech about finding hope in the war against cancer, former Vice President Joe Biden didn’t mince words about President Trump’s approach to funding biomedical science:

 

“He’s proposing draconian cuts — not only to biomedical research, but also to the entire scientific expertise across the board,” Biden said, speaking at the American Association for Cancer Research’s annual meeting in Washington.

 

This comes in stark contrast with Biden’s speech at South by Southwest festival last month in Austin, in which he was reluctant to criticize the Trump administration. But his tone seems to have shifted in the wake of the president’s new budget blueprint (read “Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!”; http://sco.lt/5qbezp).

 

Biden said the proposed $5.8 billion cut to the National Institutes of Health would be a stunning blow to scientific progress.

 

“This would set the NIH budget, and biomedical research, back 15 years — and that’s not hyperbole,” Biden said. “The chance of getting a grant would almost certainly reach an historic low.”

 

Grants, he pointed out, are funded for multiple years — and as the NIH is already committed to funding existing grants, the massive cuts would interfere with its ability to dole out further funding to researchers. In his speech, Biden cited “one reliable estimate” that up to 90 percent of grants in 2018 would be cut. It would close labs, end careers, and delay scientific breakthroughs, Biden said.

 

“This is no time to undercut progress, for god’s sake,” Biden said. “It’s time to double down — time to be sure we can deliver on the promise of science and technology to extend and improve lives.”

Pharma Guy's insight:

Yes, but keep in mind that Draco's laws came into effect at the dawn of "democracy" in Athens!

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PhRMA Lacks the Guts to “Go Boldly” & Speak Out Against Trump’s Proposed Cuts to NIH Funding

PhRMA Lacks the Guts to “Go Boldly” & Speak Out Against Trump’s Proposed Cuts to NIH Funding | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The National Institutes of Health is staring down a proposed $6 billion budget cut that could slash funding for biomedical research. The response from the drug industry’s largest lobbying group?

 

Let’s call it tepid.

 

“As we review the president’s budget proposal, we look forward to continuing to work with President Trump and Congress to improve American competitiveness and protect American jobs,” PhRMA spokeswoman Nicole Longo said in a statement. She added that the organization remains “committed to ensuring that policies support innovation and value to deliver this new era of medicines to patients.”

 

Biotech — to the extent it can be surveyed on Twitter — was not impressed.

 

“Those people are truly useless,” opined Michael Gilman, a serial entrepreneur now leading Arrakis Therapeutics.

 

“This is pathetic,” added John LaMattina, former head of R&D at Pfizer. “The new PhRMA head continues to be unimpressive.”

 

“Too bad PhRMA cannot muster the guts necessary to speak out,” tweeted Dr. Samuel Blackman, an oncologist and cancer researcher.

 

PhRMA’s bland response comes in stark contrast to statements from the Bill and Melinda Gates Foundation and the American Society of Clinical Oncology, which contained terms like “deeply troubled” and “devastate our nation’s research infrastructure.”

 

Further Reading:

Pharma Guy's insight:

I called PhRMA cowards. They certainly aren't going "boldly" into the dying of the light.

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NIH Should Stop Funding Underperforming Big Ideas in Medical Research

NIH Should Stop Funding Underperforming Big Ideas in Medical Research | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[A JAMA Viewpoint article] For several decades now the biomedical research community has pursued a narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health.

 

None of these popular topics has had any measurable effect on population mortality, morbidity, or life expectancy in the United States. The improvements of the past decades in these outcomes, which have been substantial but are now stalling, have largely reflected improvement in nonmedical aspects of everyday life and the operation of broad-based public health and classic prevention efforts, such as curtailing smoking, that are undervalued as outmoded and old-fashioned by the narrative. The anticipation that improvements in medical care and outcomes derived from big ideas will reduce costs also seems unlikely given the high costs of applying targeted therapeutic interventions to small numbers of people based on complex and expensive technologies, as well as the inevitable overdiagnosis and overtreatment that follows from more intensive monitoring. Similarly, EHRs may increase health care costs due to their ability to enhance revenue capture and as a result of unanticipated security and upgrade expenses. What historical precedent is there that adoption of vast new oversophisticated technology reduces costs? Eventually, what is the definition of success and over what time frame?

 

NIH deinvestment in preclinical research promises that clearly do not deliver will allow more funding to be directed toward work of clear public health importance and for imaginative biomedical research that is truly innovative and not constrained by current narratives.

Pharma Guy's insight:

An example of a big idea soaking up gov't funding is current Alzheimer's Disease research that focuses on one big idea: clearing the sticky plaque gumming up patients' brains is the solution (read, for example, "Another Alzheimer's Clinical Trial Failure"; http://sco.lt/4gvYGX and “Can Pharma Cure Alzheimer's Disease?”; http://bit.ly/1gmpt1D)

 

Despite repeated failures like this, there is a clamor for even more funding of such blind-alley research. Read, for example, “Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures”; http://sco.lt/75EmKf 

 

It's unlikely that NIH will reinvest in these efforts due to political pressure from interest groups such as patient advocates and drug company investors.

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NIH funds research consortia to study more than 200 rare diseases. Where's #Pharma?

NIH funds research consortia to study more than 200 rare diseases. Where's #Pharma? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Physician scientists at 22 consortia will collaborate with representatives of 98 patient advocacy groups to advance clinical research and investigate new treatments for patients with rare diseases. The collaborations are made possible through awards by the National Institutes of Health --  totaling about $29 million in fiscal year 2014 funding -- to expand the Rare Diseases Clinical Research Network (RDCRN), which is led by NIH's National Center for Advancing Translational Sciences (NCATS). 

There are several thousand rare diseases, of which only a few hundred have any treatments available. Combined, rare diseases affect an estimated 25 million Americans. Some obstacles to developing rare disease treatments include difficulties in diagnosis, widely dispersed patients and scientific experts, a perception of high risk, and a lack of data from natural history studies, which follow a group of people with a specific medical condition over time. 

"NCATS seeks to tackle these challenges in an integrated way by working to identify common elements among rare diseases," said NCATS Director Christopher P. Austin, M.D. "The RDCRN consortia provide a robust data source that enables scientists to better understand and share these commonalities, ultimately allowing us to accelerate the development of new approaches for diagnosing and treating rare diseases." 

Many patients with rare diseases often struggle to obtain an accurate diagnosis and find the right treatments. In numerous cases, RDCRN consortia have become centers of excellence for diagnosing and monitoring diseases that few clinicians see on a regular basis.

Pharma Guy's insight:


An interesting Shire Pharmaceutical survey compares the health, psycho-social, and economic impact of rare diseases on patient and medical communities in the United States (US) and United Kingdom (UK). According to patients surveyed, it takes on average 7.6 years in the US for a patient with a rare disease to receive a proper diagnosis, whereas it takes 5.6 years in the UK. For more on that, read Rare Disease Sufferers in US Worse Off Financially & Medically Than Those in UK

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NIH-Drug Industry Partnership Hopes to Develop Opioid Painkillers that are Non-Addictive

NIH-Drug Industry Partnership Hopes to Develop Opioid Painkillers that are Non-Addictive | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Top federal health officials said Wednesday that they will launch a joint effort with pharmaceuticals companies to accelerate the development of drugs aimed at helping to curb the U.S. opioid epidemic.

 

Francis S. Collins, director of the National Institutes of Health (NIH), and Nora D. Volkow, who heads one its components, the National Institute on Drug Abuse (NIDA), announced a public-private partnership aimed at cutting in half the time ordinarily needed to develop new therapies.

 

The goal is to rapidly bring to market three types of drugs: nonaddictive medications for chronic pain, better treatments for opioid addiction and improved methods of reversing opioid overdoses.

 

Every day… 90 Americans die of opioid overdoses despite the widespread availability of naloxone, which counteracts opioid's life-threatening effects.

 

Relapse is common among substance abusers despite the development of buprenorphine and other medications that treat the powerful cravings of opioid addiction.

 

Of the three goals, development of a nonaddictive but effective analgesic for severe and chronic pain would have the most far-reaching effect. Volkow said NIH can contribute by conducting research on newly understood cellular pathways for pain signaling and its relief. In the journal article, Collins and Volkow also raised the possibility of developing a drug that binds to opioid receptors in the brain and kills pain but does not create euphoria or suppress breathing.

 

Efforts to develop a nonaddictive opioid have picked up speed in recent years as the epidemic has mushroomed, after flagging in the past two decades because the medical community did not realize how addictive the drugs were or how little effect they have on chronic pain, Collins said.

 

NIH will hold workshops with officials from drug companies in six weeks and hopes to have some early results as soon as two or three years from now.

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Head of NIH Testifies Before Congress in Support of the Next Generation of Research Scientists

Head of NIH Testifies Before Congress in Support of the Next Generation of Research Scientists | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Good morning, Chairman Cole, Ranking Member DeLauro, and distinguished Members of the Subcommittee. I am Francis S. Collins, M.D., Ph.D., and I have served as the Director of the National Institutes of Health (NIH) since 2009. It is an honor to appear before you today, and it was a pleasure to host many of you at NIH in February.

 

As the nation’s premier biomedical research agency, NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems, and to apply that knowledge to enhance human health, lengthen life, and reduce illness and disability. As some of you have witnessed first-hand on your visits to NIH, our leadership and employees believe passionately in our mission. This extends equally to the tens of thousands of individuals whose research and training we support, located in every state of this great country, and where 81 percent of our budget is distributed.

 

… the future has never been brighter for advances in biomedical research than right now. Imagine what this feels like for a talented and curious new investigator. Early-stage investigators are responsible for many of the advances I’ve told you about today, and our future depends on them and their bright ideas. Those young men and women are thrilled by the prospect of exploration, and driven to help people. NIH is responsible for training these scientists, and for making sure that our investment in their careers, and the potential advances they will bring to patients, are sustained into the next stage. They are our most important resource. If advances in medical research are to continue, if research is to lead to breakthroughs that can reduce health care costs, if the considerable economic return on research is to continue, and if America is to continue its global leadership in biomedicine, we need to be sure this next generation has the confidence that there will be support for them. This is a priority for me.

 

More…

 

Further Reading:

  • “Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!”; http://sco.lt/5qbezp
  • “PhRMA Lacks the Guts to ‘Go Boldly’ & Speak Out Against Trump’s Proposed Cuts to NIH Funding”; http://sco.lt/5S7l1l
  • “Congress Rebuffs Trump and Gives NIH a $2 Billion Funding Boost - 2018 Funding Still Subject to Massive Cuts”; http://sco.lt/8wSQC1
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If The NIH's Budget Gets Slashed, Don't Expect #Pharma To Make Up The Difference

If The NIH's Budget Gets Slashed, Don't Expect #Pharma To Make Up The Difference | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The end of 2016 looked rosy for biomedical R&D funding. The 21st Century Cures Act had just been passed and it called for the addition of $6 billion to the NIH budget. The funds were added to support both Joe Biden’s “Cancer Moonshot” as well as other worthwhile research efforts. Given that the NIH budget had been at about $31 billion, this Act would provide long-sought, meaningful growth for the NIH’s efforts to understand the root causes of diseases that plague us all.

 

However, Congress can giveth, and Congress can taketh away. In President Trump’s proposed budget for the next fiscal year, he is calling for a $6 billion cut in NIH funding. Not surprisingly, the Trump proposal has raised alarms across the biomedical world. Dr. Laurie Glimcher, president of Dana-Farber Cancer Institute, put the draconian nature of this cut into perspective:

 

This more-than-decimation of the NIH budget has to be put into context. Over the last 10 years, NIH funding had already dropped by more than 13% in constant dollars–a source of great frustration to many physician-scientists, given the incredible potential we see before us in immunotherapy, in genome editing, in more efficient sequencing, in our ability to find insights within massive amounts of disparate data. Now to cut the NIH funding almost 20% beyond that… Since much of the NIH budget is devoted to ongoing grants, it is possible that the NIH may not be able to fund any new work at all in 2018.

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Coalition of Unidentified Health Industry “Stakeholders” Won’t Sit By & Watch Critical NIH-Funded Research Be Stifled – LOL!

Coalition of Unidentified Health Industry “Stakeholders” Won’t Sit By & Watch Critical NIH-Funded Research Be Stifled – LOL! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

During his budget blueprint announced earlier this month, President Donald Trump announced swingeing (sic) cutbacks across federal programs, with the National Institutes of Health (NIH) set for a $5.8 billion slashing (read “Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!”; http://sco.lt/5qbezp).

 

The blowback for Trump was however immediate, with UsAgainstAlzheimer’s, ASCO, J. Craig Venter, executive chair and founder of biotech Human Longevity, and, more moderately, BIO, all raising their concerns about what the cuts will mean for research.

 

Now, a new coalition has come out of the criticism to help preserve federal funding levels for the NIH, which were around $31 billion last year. Details were thin, but ‘The Coalition to Save NIH Funding’ is said in a release to be made of: “Stakeholders in healthcare, research, pharmaceutical development, patient advocacy and other non-profit organizations.”

 

Exactly who these are have not been made public as yet, with the PR posted by health campaign firm JPA Health Communications. The members will however be the ones to set the agenda and priorities for the Coalition.

 

“While JPA will be coordinating the traditional materials (i.e., position papers, media engagement), our efforts are focused on helping people understand why research is important, why and how patients benefit from it, and why the cuts will be devastating in state and local districts. What develops from basic research touches each and every one of us. We must protect it.”

 

“We were dismayed to learn that the NIH is vulnerable to deep funding cuts,” said Carrie Jones, principal of D.C.-based JPA. “Each day America benefits from the innovation and scientific discoveries made at the NIH. We won't sit idly by and watch critical research be stifled.”

 

Further Reading:

  • “PhRMA Lacks the Guts to ‘Go Boldly’ & Speak Out Against Trump’s Proposed Cuts to NIH Funding”; http://sco.lt/5S7l1l
Pharma Guy's insight:

Who are these bozos? Don't they know that their protest is worthless if they do not identify themselves! More cowards!

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Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!

Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The National Institutes of Health would absorb an enormous $5.8 billion cut under President Trump’s first budget proposal — equal to about 19 percent of its current $30.3 billion discretionary budget.

The plan “includes a major reorganization” of NIH’s 27 institutes and centers and would eliminate the Fogarty International Center, a $69.1 million program dedicated to building partnerships between health research institutions in the United States and abroad.

With few details available in the budget outline, it is unclear what kind of reorganization the administration envisions at NIH, the crown jewel of U.S. biomedical research. The agency funds research into a vast array of diseases and conditions, including cancer, heart disease, developmental disorders and mental illness.

The agency passes out more than 80 percent of its money to more than 300,000 researchers at universities across the country and abroad. It also has hundreds of researchers conducting studies in labs at its sprawling campus in Bethesda, Md. Its world-renowned clinical center treats patients from around the world seeking last-chance cures and volunteers testing cutting-edge therapies.

Pharma Guy's insight:

This is part and parcel of the current anti-science sentiment and a good reason for pharma people to participate in the April 22 March for Science: http://sco.lt/8TdiaH 

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NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C

NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.


The study, called ASCEND, is co-sponsored by the NIH’s Clinical Center and National Institute of Allergy and Infectious Diseases (NIAID), with additional support from the NIH Office of AIDS Research. The study is being conducted as part of the D.C. Partnership for HIV/AIDS Progress, a program that aims to reduce the burden of HIV/AIDS and associated diseases, such as hepatitis C, in the District of Columbia.


More than 3 million people in the United States are infected with HCV. If left untreated, the infection can lead to cirrhosis (liver scarring), liver cancer and eventual liver failure. Chronic HCV infections contribute to thousands of deaths each year, and hepatitis C is a leading cause of death for people co-infected with HIV. In the United States, hepatitis C infection is largely centered in urban areas and disproportionately affects minority, low-income and marginalized populations, such as the homeless and people who inject drugs.


In the past, hepatitis C treatment involved long-term use of oral and injectable medications, some of which had unpleasant side effects, including flu-like symptoms and depression. Because of the complexity of these regimens, hepatitis C treatment has largely been provided by specialist physicians, such as infectious disease specialists and hepatologists. New oral direct-acting antiviral drugs may offer more effective, shorter-duration, curative treatments. In October 2014, the U.S. Food and Drug Administration approved a new, once-daily antiviral drug for treatment of hepatitis C infection that combines ledipasvir and sofosbuvir (trade name Harvoni). Gilead Sciences, based in Foster City, California, manufactures the drug and is providing it free-of-charge for use in the ASCEND study.


“The recent advent of direct-acting antiviral medications has offered promising new treatment options for people who are chronically infected with hepatitis C,” said NIAID Director Anthony S. Fauci, M.D. “These therapies have yielded high cure rates in clinical trials led by specialized care teams. The ASCEND study will help determine whether these medications are similarly effective when administered in an urban, community-based setting.”

Pharma Guy's insight:


This study will monitor patients over a 10-year period for short-term and long-term treatment outcomes, including viral response to the drug and evidence of liver damage. That will answer my question about the true effectiveness of these drugs; i.e., whether they actually "cure" Hep C over the long term as implied by the advertising and social media hype. 

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