China Withholding Deadly Flu Samples from U.S. Researchers

Americans have zero immunity against the deadly H7N9 flu, and China is refusing to share much-needed samples with U.S. Researchers hoping to combat a potential outbreak.

More than a year after a deadly H7N9 avian influenza outbreak spiked in China, infecting 766, U.S. researchers have yet to receive samples of the viral strain to help them develop vaccines and treatments to combat it, despite persistent requests from officials and research institutions, according to reporting from The New York Times.

A new strain of H7N9 first surfaced in China in 2013, infecting both humans and animals, though the National Institutes of Health has said the strain is not easily transmitted between humans—most human infections were in those who had contact with live poultry or visited markets where the birds were sold. Still, it is concerning, as there have been five significant outbreaks of the virus, which has a near 40% fatality rate, and, if it mutates, it has the potential to cause a pandemic, as most people—especially Americans—have little to no immunity against it, making research essential.

Under an agreement established by the World Health Organization, participating countries—which has, until this point, included China—must transfer influenza samples with pandemic potential to predetermined research centers around the world, in a “timely manner.”

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

First Generic EpiPen Approved by FDA

On the heels of a massive EpiPen shortage, the U.S. Food and Drug Administration has approved the first generic alternative.

The U.S. Food and Drug Administration has approved the first generic alternative to the EpiPen and EpiPen Jr (epinephrine) auto-injector, which is used for the emergency treatment of allergic reactions, including those that are life-threatening, in adults and children.

The approval of a generic alternative to the EpiPen and EpiPen Jr., made by Teva Pharmaceuticals USA, comes on the heels of a major EpiPen shortage that has left parents of school-age children scrambling to find them as the school year begins, and which has resulted in the FDA extending EpiPen expiration dates. The FDA came to this decision after Mylan, the manufacturers of the EpiPen, requested the extension, and provided data to show that it would be safe to use them past their 20-month listed shelf life.

This approval was described as, “part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” by FDA Commissioner Scott Gottlieb, M.D.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Trump Administration Sinks Teeth Into Paring Down Drug Prices, On 5 Key Points

Three months after President Trump announced his blueprint to bring down drug prices, administration officials have begun putting some teeth behind the rhetoric.

Sarah Jane Tribble, Kaiser Health News

Three months after President Donald Trump announced his blueprint to bring down drug prices, administration officials have begun putting some teeth behind the rhetoric.

Many details have yet to be announced. But experts who pay close attention to federal drug policy and Medicare rules say the administration is preparing to incrementally roll out a multipronged plan that tasks the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration with promoting competition, attacking the complicated drug rebate system and introducing tactics to lower what the government pays for drugs.

Mark McClellan, director of the Duke-Margolis Center for Health Policy in Durham, N.C., and a former CMS administrator, said that although none of the initial steps has “fundamentally transformed drug prices,” there is “a lot going on inside the administration.”

Two HHS officials who are rolling out the plan, Dan Best and John O’Brien, described their efforts to Kaiser Health News not as a public relations strategy but a push to reform the system.

“This administration is trying to go after root causes” of high drug prices, said Wells Fargo analyst David Maris.

But others are not so optimistic.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School in Boston, said policies the administration has rolled out thus far “alone will not translate into meaningful cost savings for most Americans.”

Broadly, the strategy falls under a handful of steps:

1. Attacking The Rebates

Health and Human Services Secretary Alex Azar has said Americans “do not have a real market for prescription drugs” because drug middlemen and insurers get a wide range of hidden rebates from drugmakers, but those savings may not be passed on to consumers or Medicare. In July, the administration submitted a proposed rule that could change the way rebates are handled.

Details of the proposal have not been made public. But O’Brien, a deputy assistant secretary at HHS, explained during a recent conference on federal drug spending sponsored by the Pew Charitable Trust: “You don’t have to use market power to get rebates, you can use market power to obtain discounts, to actually lower the price of the drug on the front end.”

Umer Raffat, an investment analyst with EverCore ISI, said “it’s not clear [that drug prices are going down]” but the “rebate structure is changing.”

2. Bringing More Negotiation To Medicare

This week, CMS Administrator Seema Verma announced that Medicare Advantage insurers can use a step-therapy approach to negotiate better prices for Part B drugs — those administered in hospitals and doctors’ offices. These private plans will be allowed to require patients to first select the least expensive drug before stepping up to more costly drugs if the original medications aren’t working.

The administration is also looking at ways to introduce more competition into Part B drug purchasing. That idea was mentioned deep inside the annual Medicare outpatient payment rule released last month.

Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes in New York, pointed to the possible introduction of a competitive purchasing program in which a firm negotiates with drugmakers to buy their drugs and then sells them to the doctors and hospitals that will administer the medications. Bach said that helps ensure that hospitals and doctors can’t make more money by prescribing more expensive drugs.

Currently, Medicare pays the average sales price plus 6 percent to doctors or hospitals when they purchase drugs, a pricing mechanism that can benefit the providers if the drug costs go up. If there were a third party buying the drugs, it would “have a huge effect,” Bach said.

3. Paying For Value

Trump’s blueprint calls for CMS to encourage “value-based care” to lower drug prices, shifting from paying a set fee for drugs to basing payments on how well the patient does on them.

Louisiana’s Medicaid program could show the way. The state is working with CMS to explore a subscription-based model to pay for hepatitis C medicines. Louisiana would pay a fixed price to a drug manufacturer that would then get unlimited access to treat patients enrolled in Louisiana’s Medicaid program or in prison.

The program would move “from a big payment upfront to paying less over time based on actual outcomes,” said McClellan, who also serves on the boards of health care giant Johnson & Johnson and insurer Cigna.

CMS also approved a Medicaid waiver from Oklahoma in June. Medicaid programs are allowed to negotiate drug prices. Oklahoma’s plan would expand that to negotiate additional prescription price reductions based on value-based purchasing agreements.

Still, CMS’ recent rejection of a related Massachusetts proposal makes it difficult to believe negotiating drug prices will really happen, said Sara Rosenbaum, a professor of health law and policy at George Washington University.

That proposal would have allowed Massachusetts’ Medicaid program to choose drugs based on cost and how well the medicines work.

“They have been very good and quite careful with their [Medicaid] program and so why not let them try this?” Rosenbaum said.

4. Tackling Foreign Drug Costs

Pharmaceutical makers often sell their drugs at substantially lower prices in many foreign countries than they do in the United States. Trump emphasized in May that “it’s time to end the global freeloading once and for all,” saying U.S. consumers were paying part of the cost of the medicines that patients in other countries use.

He directed U.S. Trade Representative Robert Lighthizer to address the situation. Lighthizer’s office declined to comment.

When Sen. Todd Young (R-Ind.) asked during a Senate health committee hearing in June whether trade agreements with other countries should be used to “level the playing field,” Azar’s response was swift: “We absolutely believe we should be using our trade agreements to get them to pay more even as we have our job to pay less.”

Avalere Health President Matt Brow, who has been involved in talks with the administration, said it’s clear the focus on overseas pricing isn’t going away and the administration is “talking a lot about how to get the president what he wants.”

5. Increasing Competition

FDA Commissioner Scott Gottlieb has become the Trump administration’s lead proponent for increasing competition among drugmakers.

Competition resonates with Americans “because people see it every day in their experience in Costco and other places,” said Rena Conti, an associate professor at the University of Chicago.

Gottlieb has announced plans to bolster the use of generic drugs and an “action plan” to encourage the development of biosimilars, which are copycat versions of expensive biologic drugs made from living organisms.

And to combat anti-competitive behavior in the market, Gottlieb said the FDA has passed along information to the Federal Trade Commission and hinted at potential action to come: “I think we’ve handed them some pretty good facts.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.


Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

“Ask Your Doctor About…” Coming to a Computer Near You?

Digital ads for prescriptions are approaching parity with TV ads, with an even larger percentage of patients who saw ads online asking their doctors about specific medications.

A recent study by DRG Digital (formerly Manhattan Research) has shown that not only do two out of three adults recall seeing or hearing advertising for prescription drugs in the last 12 months, but that digital advertisements are approaching parity with traditional television-based advertisements.

Of those who indicated they had recalled advertisements, nearly two-thirds of respondents (65%) stated they had remembered seeing or hearing an ad for medications on TV, and just under half (49%) stated that they remembered seeing or hearing ads online. Of those who recalled seeing or hearing an ad on television in the past 12 months, 22% did as the ad suggested and asked their doctor about a specific drug, compared to 42% of those who recalled seeing or hearing an ad online.

The data suggests that online drug advertisements may be as effective, or even more effective, than traditional television advertisements at prompting patients to ask their doctors about specific prescription drugs.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

R&D Spend Hit Record High for Biopharma Companies in 2017

Biopharma companies invested a total of $71.4 billion in research and development in 2017, up from $65.5 billion in 2016 and a record high.

According to the 2018 Pharmaceutical Research and Manufacturers of America annual member survey, biopharma companies invested a total of $71.4 billion in research and development (R&D) in 2017, up from $65.5 billion in 2016 and the highest ever recorded level of R&D spend in the industry. Survey results also showed that nearly one out of every five dollars of revenue was devoted to R&D, and of the total R&D spend, Phase 3 testing accounted for nearly 30% of it, making it the most expensive part of the process.

Nearly one-sixth of total domestic R&D spending by American businesses is made up by U.S. biopharma companies. These investments have helped to pave the way for groundbreaking medical advances and essential therapies throughout the world, including the 56 novel medicines approved by the FDA in 2017, including the first cell and gene therapies, the first medicine for primary progressive multiple sclerosis (PPMS), and the first treatment for sickle cell disease in 20 years.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

US Congressman/Former BioPharma Company Board Member Arrested

Chris Collins, the United States Representative for New York’s 27th congressional district, has been arrested by the FBI on charges of insider trading.

Chris Collins, the United States Representative for New York’s 27th congressional district, has been arrested by the FBI on charges of insider trading and lying to the FBI.

It is alleged Collins, 68, used his position with an Australian biopharma firm, Innate Immunotherapeutics, to help his family and friends make illegal stock trades, and to avoid massive losses of more than $768,000. Collins served as a board member for Innate Immunotherapeutics, a small North Melbourne-based pharmaceutical company, for three years, until 2017, and he currently owns 17% of their stock, making him one of the company’s biggest shareholders.

The charges allege that Collins received an email from Innate’s CEO, Mondher Mahjoubi, in June of last year, warning him that the company’s only drug, the multiple sclerosis treatment MIS416, had failed in its latest trials. It is alleged that Collins and his collaborators managed to avoid losses of more than $768,000 by disposing of 1.39 million shares as the result of this tipoff.

On Wednesday, August 8, 2018, Collins called the charges “meritless,” and went on to say, “I’ve said it before and I’ll say it again: I am proud of my affiliation with Innate.”

The U.S. Securities and Exchange Commission also announced Wednesday that it has filed securities fraud charges against Collins, after they began investigating his stock dealings in January of 2017.

Collins has pled not guilty to the charges and has been released on a $500,000 bond. His next court date is scheduled for October 11, 2018.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

FDA Supports New Steps to Further Nicotine Replacement Therapy Research

Use of FDA-approved nicotine replacement therapy products may double the likelihood of a successful attempt to quit smoking.

In a statement released this month from FDA Commissioner Scott Gottlieb, M.D., it was announced that the agency is taking new steps to support the development of nicotine replacement drug therapies (NRTs) to assist smokers in their efforts to quit.

“As a public health agency, there is no greater impact we can have to improve the health of our nation than to significantly reduce the rate of tobacco-related disease and death. Through the U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco, we’re developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction. A key part of this framework are steps to pave the way for products that help currently addicted smokers move away from the deadliest form of nicotine delivery,” Gottlieb said in the statement, which was issued on August 3, 2018.

Gottlieb goes on to say that, “The development of novel NRT products, regulated as new drugs, is a critical part of our overall strategy on nicotine.”

The CDC reports that nicotine may be as addictive as heroin, cocaine, or alcohol, and that 70% of adult smokers in the United States want to quit, with nearly half trying to quit each year and only few succeeding. Research has shown that use of FDA-approved NRT products may double the likelihood of a successful quit attempt.

The FDA’s Nicotine Steering Committee, established in September of 2017, has been evaluating new, evidence-based opportunities to advance NRT products, and last week, the FDA released the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies, similar to current over-the-counter pharmaceutical NRT products, that could be submitted to the FDA for approval as new drugs.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping their focus on the science.

from BioPharm International

A biopharma company answers to multiple masters: the patient who depends on effective drug products for health or survival; regulatory authorities that monitor quality; and investors that demand financial performance. Maintaining a balance of multiple, sometimes conflicting priorities is no easy task for companies at any development stage.

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Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

FDA Forms Drug Shortages Task Force

The task force is charged with identifying the reasons why some shortages remain a persistent challenge and to look for holistic solutions to addressing the underlying causes for these shortages.

from PharmTech.com

In response to urging from lawmakers, FDA Commissioner, Scott Gottlieb, announced formation of a new drug shortages task force and efforts to advance long-term solutions to prevent shortages. Despite a decline in drug shortages since 2011 due to efforts by FDA, industry, and other groups, shortages continue, and more must be done, said Gottlieb in a statement.

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Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Fund Cancer Detection, Not a “Cure”

Your best weapon to defeat the beast known as cancer is early detection. So, why is funding so focused on finding a “cure,” instead of screening?

by Jason Blackson

There is an inherent misnomer about cancer prevalent in the world that needs to be corrected. Cancer is a disease of the body’s own cells developing a molecular flaw and then replicating out of control. For this, there is no cure. Not in the preventative sense that has led numerous foundations, organizations, and charities to generate billions of dollars over the years under the guise of finding ‘the cure’. An individual’s cancer can be cured, yes, but there will never be a drug or vaccine that could be administered to prevent cancer. Diseases, like the chicken pox or the flu, are foreign entities that enter the body and can be fought off, either by vaccine or the use and aid of medications. Other diseases can be fought off by the immune system, such as bacterial infections. Cancer is not an invasive substance. Cancer is our own cells gone rogue and then convincing our bodies that it belongs there. Because the immune system does not recognize cancerous cells as anything foreign, it will do little, if anything, to fight back. There is no cure to prevent this from happening. That isn’t to say there is no hope. Rather there needs to be a shift in focus, taken away from ‘finding the cure’ and placed on developing more efficient diagnostic testing. Pouring money into research to hit the bullseye at an ever-changing target isn’t the answer. The answer lies in finding these rogue cells, before the race against time begins.

The development of better treatment options has grown, evolved, and advanced in the most remarkable and unforeseeable ways, over the last several decades. While some routes of treatment are still borderline-barbaric, for lack of a better option, new developments, especially immunotherapy, have provided hope for patients with even the most egregious forms of cancer. Their diagnosis isn’t necessarily a death sentence. The problem here being that funding for this type of research is inconsistent. Studies have shown that over the last decade, while public support and research progress remain strong, funding has not increased to compensate for the demands of a pricier financial landscape. The federal government has provided tremendous monetary support for research, but has yet to meet the same level of funding it provided before the last recession. Grants have helped to offset expenditures for many organizations, but the overall tight financial constraints have created challenges in sustaining clinical trials and retaining talented researchers. Additionally, the horrifying and fascinating reality is cancer cells have routinely found ways to evolve and survive many of the implemented therapies. This is because each type of cancer has a unique combination of genetic changes. As the cancer grows, these genetic changes will continue, making each subsequent cell different from its parent cell. Cells within the same tumor have even shown to have different genetic changes. This is one reason why cancers become more difficult to treat over time and also why one therapy regime that works for one patient may not necessarily work for another patient with the same diagnosis. This, of course, is spoken in broad stroke generalizations. There are numerous studies proving the success and survival rates of any combination of therapies, and new research is showing new treatment options to be even more promising. But why is the focus of defeating cancer on the backend, after it has already wreaked havoc on the life of the patient and the lives of the people around the patient? Why is research less focused on the frontend of the disease process and preventing it from developing beyond a few cells?

CBCs, biopsies, colonoscopies, pap tests, and other tests are routinely used in conjunction with known statistics and demographics in screening patients for cancer. Current screening tests are predominantly accurate in the detection of tumors or blood- or bone marrow-based cancers but typically those cells number in the millions before being detected. The human body has trillions of cells and, of those cells, cancer starts in just one. Understanding the nature of that one cancer cell, how it operates, and how it operates differently from normal cells, could help doctors not only detect the cancer earlier, but also help them refine their treatment to be the most efficient. For example, cells from tumors are known to release minute amounts of mutated DNA and abnormal proteins into the blood stream, not unlike normal cells. Researchers in Australia have used this information to develop a test that can detect one mutated fragment of DNA among 10,000 normal DNA fragments. Research from Johns Hopkins Kimmel Cancer Center, in conjunction with the National Cancer Institute, has supported these findings by developing a technique that detects specific mutated DNA sequences. Additionally, a study out of China has identified cancer cells carry sugar molecules on their surfaces that are not found on the surfaces of normal cells. These are characteristics of all tumor cells that, with additional research and test development, can be used to create a screening tool that will detect cancer even before symptoms arise. Not only will this be crucial in increasing the overall survival rate of many types of cancer, a blood analysis test in far less invasive and inherently less expensive than many of the currently used screening tests.

The next step, as with any research study, is proven accuracy with redundancy and time. Much of this early detection research has been reported in the last twelve to eighteen months. Even with the promising accuracy of these tests on subjects within the study, the incidence of cancer developing in the test subjects, in comparison to the control groups, will have to be monitored over the next several years. Meaning, the research and the researchers will need to be funded to conclude their current studies, in addition to refining and improving their work. While no detection test for any malady can guarantee 100% accuracy, there is no reason to believe a cancer screening test could not be close to it. Ideally, equal amounts of money, time and effort could be used for treatment development and early detection test development, but it is realistically implausible. Cancer cells are known to replicate out of control without stopping and will, most likely, go undetected until the patient exhibits symptoms. There needs to be a test to identify these cells before they cause harm, before they create a physical manifestation that will lead to costly, unpleasant, and oftentimes painful treatments to eradicate them. Funding efforts and public perception need to be shifted away from finding a cure to the more feasible prospect of detecting cancer earlier and stopping it from developing into a life-changing beast.


Jason Blackson is a Clinical Laboratory Specialist, who lives in Washington, D.C., and has worked in Cytogenetics for nearly two decades. When he is not busy in the lab, he enjoys traveling the world, especially for concerts, staying fit, and telling what some would consider to be “dad jokes.”

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.