Are Doctors Bribed by Pharma? An Analysis of Data.

An in-depth look at a recent paper that explores correlational data relating opioid prescribing to opioid manufacturer payments.

from The Health Care Blog

Association studies that draw correlations between drug company-provided meals and physician prescribing behavior have become a favorite genre among advocates of greater separation between drug manufacturers and physicians. Recent studies have demonstrated correlations between acceptance of drug manufacturer payments and undesirable physician behaviors, such as increased prescription of promoted drugs. The authors of such articles are usually careful to avoid making direct claims of a cause-effect relationship since their observations are based on correlation alone. Nonetheless, such a relationship is often implied by conjecture. Further, the large number of publications in high profile journals on this subject can only be justified by concerns that such a cause-and-effect relationship exists and is widespread and nefarious. In this article, we will examine a recent paper by Hadland et al. which explores correlational data relating opioid prescribing to opioid manufacturer payments and in which the authors imply the existence of a cause-and-effect relationship.

Read More →

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.

Retooled Vaccine Raises Hopes As A Lower-Cost Treatment For Type 1 Diabetes

The increasing cost of Type 1 diabetes, one of the most common serious chronic diseases, has created heavy financial burdens for families, with insulin prices more than doubling in the past decade.

By Carmen Heredia Rodriguez, Kaiser Health News

For Hodalis Gaytan, 20, living with Type 1 diabetes means depending on an assortment of expensive medicines and devices to stay healthy. Test strips. Needles. A glucose meter. Insulin.

The increasing cost of Type 1 diabetes, one of the most common serious chronic diseases, has created heavy financial burdens for families and generated controversy, with insulin prices more than doubling in the past decade.

Without her parent’s insurance, “I would not be alive,” said Gaytan, a student at the University of Maryland.

The burden of treatment is why a small study that shows promise for a simpler, cheaper alternative treatment to Type 1 diabetes is being met with hope — but also with caution and skepticism.

The research, published June 21 in the journal Nature Partner Journal Vaccines, showed that an older generic vaccine may help lower the blood sugar level of patients with Type 1 diabetes, decreasing their need for insulin. The vaccine, BCG, is used in a number of countries to prevent tuberculosis and has long been known to stimulate the immune system as well. That vaccine is relatively cheap, costing about $157 per dose in the United States, according to the health care technology company Connecture.

In the study, participants with long-standing Type 1 diabetes were injected with two doses of Bacillus Calmette-Guerin tuberculosis vaccine — known as BCG — four weeks apart. Three of the patients were observed for eight years. Nine participants were followed for five years.

The blood sugar levels — known as A1c — of those followed for eight years dropped by more than 10 percent three years after the injection and were sustained for five more years.

While the trial involved a tiny number of patients, the researchers — led by Dr. Denise Faustman, director of the Immunobiology Laboratory at Massachusetts General Hospital — are conducting a much larger Phase 2 trial of BCG to treat diabetes to see if the results hold up.

JDRF, a leading nonprofit organization that provides funding for research on Type 1 diabetes, and the American Diabetes Association issued a joint statement shortly after the new study was released, cautioning against misinterpreting the findings and stating that they “do not provide enough clinical evidence to support any recommended change in therapy at this time.” Both groups have partnered with drug manufacturers and device makers in the industry.

Still, Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami, said he is “cautiously optimistic” about the findings, noting the “incredibly high price tag” for patients with diabetes. But he warned against generating “too much hype” among families before the treatment is proven to be effective.

Dr. Joseph Bellanti, professor emeritus of pediatrics and microbiology and immunology at Georgetown University Medical Center in Washington, D.C., was also encouraged by the studies’ findings. While he acknowledged the skepticism surrounding Faustman’s research, scrutiny is a necessary part of the scientific process, he said.

“We’re seeking the truth, and we want to make sure that the results and the interpretations are correct, Bellanti said, “and that requires healthy debate.”

Faustman said her findings are important because they suggest that the vaccine could have positive effects in the treatment of diabetes, similar to what has been seen in previous research on other autoimmune diseases, like multiple sclerosis, that involve an immune system reaction against normal tissue.

“It also opens up a host of new possible treatment avenues,” Faustman said, adding that it could help in developing interventions for other groups suffering from chronic illnesses.

Type 1 diabetes, which typically is diagnosed in childhood, occurs when the immune system destroys the cells that produce insulin. People with Type 2 diabetes produce normal levels of this vital hormone, but their bodies don’t respond appropriately.

These findings surface as the country grapples with soaring insulin prices — a rise so significant it has prompted attorneys general in several states and at least one federal prosecutor to launch investigations targeting insulin makers Eli Lilly, Novo Nordisk, Sanofi and pharmacy benefit managers.

The United States already pays a steep price for its diabetes burden. According to the American Diabetes Association, the 24.7 million Americans living with the diagnosis last year spent $237 billion in direct medical costs.

For patients like Gaytan, the prospect of new medications to simplify and reduce the costs of her treatment is tantalizing. She injects herself with insulin and checks her blood sugar level about five times a day. And she attends therapy to help deal with the burden of living with a chronic condition, and worries about how she’ll afford it in the future.

“I know diabetics [whose] families pay for everything,” she said, adding they “just can’t afford it.”

According to Connecture, the list price for Apidra SoloStar — an injectable insulin product that Gaytan uses several times per day — increased from $33.24 per pen in early 2009 to $104.28 per pen in early 2018.

Faustman said her research has documented the mechanism by which the old vaccine reduces blood sugar levels. In the Phase 2 trial, she will attempt to replicate her findings by following 150 participants with the disease for five years. It will be at least another four years until results are published.

Ultimately, if BCG works to treat Type 1 diabetes, its current cheap price could rise, said Gerard Anderson, professor of health policy and management and medicine at Johns Hopkins University in Baltimore, who, like Kaiser Health News, receives money from the Laura and John Arnold Foundation. Though BCG is generic, pharmaceutical companies can raise the price by altering the drug and issuing a new patent.

Drugmakers are expert at retooling old drugs to treat new conditions, he said, adding: “It could result in no cost savings at all — and, in fact, a higher price.”


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

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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.

Fifteen Years of Progress: Biopharmaceutical Industry Survey Results

Take a look at highlights from 15 years of changes in biopharmaceutical manufacturing.

from BioPharm International

Since 2003, BioPlan Associates, Inc. has published an extensive annual survey of bioprocessing professionals. Since the first survey, which was started in collaboration with the American Society for Microbiology, critical bioprocessing issues have grown. The annual report has expanded to include 60 questions with nearly 500 pages of analysis and data. Manufacturing capacity issues have always been at the core of the annual survey, but as the industry has matured, the factors impacting capacity have become more complex.

Read More →

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.

Philanthropists Are Getting Behind a New Push for Government Science Funding

Only one in four Americans believes the U.S. government’s role in funding research is irreplaceable, according to a study by ScienceCounts.

from Inside Philanthropy

A handful of private funders have joined several professional societies and a couple of corporate partners in support of ScienceCounts, an emerging effort to protect government funding of science by bolstering public support.

Read More →

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 Involves Patient Perspectives in Regulatory Review Process

The FDA established the Patient Engagement Advisory Committee in a move to broaden patient engagement and strengthen patients’ voice in regulatory activities.

from Becker’s Hospital Review

This is the first FDA committee that is only comprised of patients, patient advocates and caregivers. The committee will discuss and make recommendations at each stage of product development — including design, clinical trials and ultimately product approval.

Read More →

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.

Do Pharma’s Claims On Drug Prices Pass The Smell Test? We Found 5 Stinkers.

The pharmaceutical industry fears major legislation that would curb prices and shrink profits, and has launched campaigns against it—but how honest are their claims?

By Jay Hancock

Drug companies launched an ad and publicity extravaganza this year right after President-elect Donald Trump said they “are getting away with murder” on sky-high pill prices.

More than it has in years, the pharmaceutical industry fears major legislation that would curb prices and shrink profits. TV spots lauding drug companies, quoting poet Dylan Thomas and showing heroic scientists have been hard to escape.

But the narrative from the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group, is only the rosiest, most self-serving version of the tale, say critics, and numerous independent authorities question its assertions.

They say the campaign is misleading in these five ways:

1. Lowballing drugs’ cost to society.

For years, PhRMA said retail prescription drugs account for only 10 percent of America’s enormous health care bill. Lately, the group has been using a figure of 14 percent, counting chemotherapy and other drugs delivered in hospitals and doctor offices.

Both numbers downplay the expense of prescription meds. Arriving at the industry’s estimates requires lumping drug costs in with billions in public health spending, such as checking water and animals for pathogens, as well as nursing home care and other categories only loosely connected to the day-to-day job of healing the sick.

Retail drugs alone were 21 percent of the cost in 2014 for employer-sponsored health plans, often exceeding costs for inpatient hospital treatment. Add chemotherapy and other non-pharmacy drugs, and the portion is higher.

At CareFirst, a BlueCross BlueShield plan with members in Maryland, Virginia and the District of Columbia, total drug costs when chemotherapy and other hospital-administered medicines were added became a thumping 34 percent of the expense in the first half of 2017, says CEO Chet Burrell. By contrast, inpatient care, traditionally the most expensive health service, is about 20 percent of CareFirst’s costs.

“That tells you about the power of what’s going on with the drug prices and the degree of use of the drugs,” Burrell said.

2. Exaggerating drug development costs.

Inventing, testing and launching a drug costs $2.6 billion, calculates the Tufts Center for the Study of Drug Development. The industry substantially finances the center’s work, leading many to question its credibility. Drug companies use its conclusions to justify high prices and cite this figure at every turn.

Outside authorities criticize the research, saying it comes from untestable data, ignores enormous tax subsidies that reduce costs and inflates results with imaginary expenses, such as profits that could have been earned if drug companies invested research dollars elsewhere.

“These estimates are all based on secret, unverifiable numbers of unknown reliability from unknown companies about unnamed drugs,” said Donald Light, a health policy professor at Rowan University in New Jersey.

The Tufts results line up with publicly available data, counters Joseph DiMasi, economic analysis director for the Tufts Center. “If anything, they suggest our estimates are conservative,” he said.

But an independent study published in September using public filings found the median cost of developing 10 cancer drugs was $648 million, while the median revenue per drug was $1.7 billion.

Light and other critics especially object to counting, as part of development costs, the theoretical profit firms might have earned if they put research money into something other than inventing drugs — such as buying extra ads for existing products. That adds more than $1 billion to the supposed cost.

What settles the argument is drugmakers’ audited financial statements, which show that costs of all kinds are far below what they collect in revenue. Ten of the top publicly traded U.S. drug companies earned profits of $83.6 billion last year on revenue of $306 billion, regulatory filings show. That’s a 27 percent pretax profit margin — accomplished even after spending billions on TV ads and salespeople.

3. Cheering too loudly about a slowdown in drug costs.

Fueled partly by hepatitis C medicine costing as much as $1,000 a pill, retail prescription drug spending soared by 12 percent in 2014 and another 9 percent in 2015, according to government data. That was the biggest two-year increase in a decade.

So it’s no surprise growth is reverting to the mean now that there are fewer new blockbusters. Government figures aren’t in yet for 2016. But QuintilesIMS, which tracks wholesaler sales, says drug spending grew 4.8 percent last year.

“The slowest rate in years,” brags PhRMA, quoting a magazine. Actually, drug-spending growth was even lower from 2010 to 2013 before roaring back.

In any case, 4.8 percent is still twice the inflation rate for 2016 and greater than economic growth, which determines what the country can afford over the long term.

New drugs arriving to market, often involving living cells and gene therapy, look more expensive than ever. The announced cost for Novartis’ Kymriah therapy for kids with leukemia is $475,000 for a one-time treatment.

Drug companies seem to show concern about high prices only when there’s a danger Congress might do something about them. In January, AbbVie loudly promised to keep price increases under 10 percent this year. Now that political pressure has subsided, company executives said recently they have more “flexibility” to revert “to double-digit increases in 2018 and beyond,” according to a Sept. 22 report from Leerink, an investment research firm.

AbbVie subsequently said Leerink “incorrectly characterized” the remarks. The drugmaker promised to make “one, single-digit price increase” for 2018.

4. Exaggerating the role of generics.

“Nearly 90 percent of all medicines dispensed in the United States are generics,” says PhRMA, trying to argue drugs are cheap.

The group doesn’t mention that brand-name medicines are responsible for 74 percent of prescription costs and that drugmakers do everything in their legal power to keep pills from going generic after patents expire.

“PhRMA has fought for years to keep generics off the market,” said Robin Feldman, a law professor who researched the subject for a book, “Drug Wars,” published in June, which she co-authored. “The brunt of the pain of that is felt by U.S. citizens,” who pay more for medicine than anybody in the world, she said.

Industry tactics have included paying makers of generics not to make pills; filing dubious petitions opposing generics that cause months of delay; withholding samples that generics companies need to launch their own pills; and changing dosages or delivery mechanisms in tiny ways to get a new patent, Feldman said.

5. Exaggerating benefits from new drugs.

“Since 2000, biopharmaceutical companies have brought more than 500 new medicines to U.S. patients, resulting in significant progress against some of the most costly and challenging diseases,” says one of PhRMA’s promotions.

Rather than being breakthroughs, however, too many new drugs are “me-too” substances based on previous research, critics say. Many aren’t demonstrably better than cheaper, already available drugs yet get heavily promoted through expensive ads and salespeople.

Bernard Munos worked for years at Eli Lilly and now is a consultant and sits on the board of several small, drug-related companies. He credits the industry with creating drugs that “are superb and make a difference,” such as Gleevec, Novartis’ blood-cancer drug.

But there are not nearly enough of them, he says.

“One of the challenges of the industry is that, despite all of its efforts, it has not been successful in producing more of the really transformative drugs,” he said. “Mediocre drugs are starting to price themselves at almost the same level as the really innovative drugs. And this is a market failure.”


This story was produced by Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

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.

Feds Pay $8M+ to Promote ‘Diversity’ in STEM

The National Science Foundation recently issued 27 new grants totaling more than $8 million to promote “diversity and inclusion” in STEM fields.

from Campus Reform

The National Science Foundation has recently announced the launch of 27 new “diversity and inclusion” projects funded through grants of roughly $300,000 each through its NSF INCLUDES program, which seeks to develop STEM talent “from all sectors and groups in our society.”

Read More →

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.

BU Wins $20M for NSF Engineering Research Center

The recipient’s ultimate goal is to advance nano-bio-manufacturing methods that could lead to large-scale fabrication of functional heart tissue, which could replace diseased or damaged muscle after a heart attack.

from BU.edu

Boston University has won a $20 million, five-year award from the National Science Foundation (NSF) to create a multi-institution Engineering Research Center (ERC), with the goal of synthesizing personalized heart tissue for clinical use. The grant, which is renewable for a total of 10 years and $40 million, is designed to accelerate an area of engineering research—in this case, bioengineering functional heart tissue—that is likely to spur societal change and economic growth within a decade. “The goal is moving from the basic research capability to a technology that could be disruptive,” says BU College of Engineering Dean Kenneth Lutchen, who notes that the ERC program is designed to stimulate translation of research to practice by facilitating worldwide corporate, clinical, and institutional partnerships. “The center will transform cardiovascular care by synthesizing breakthroughs in nanotechnology and manufacturing with tissue engineering and regenerative medicine,” he says.

Read More →

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 Moves To Guard Against Abuse Of ‘Orphan Drug’ Program

The FDA is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

By Sarah Jane Tribble

The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases.

A KHN investigation earlier this year, which was published and aired by NPR, found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the world’s best-selling drug.

Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.

“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Gottlieb, through his agency, declined multiple requests for interviews.

Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases — even though many of them also treat and are marketed for common diseases.

Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.

The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.

Those include:

  • Eliminating a backlog in drug applications for orphan designation or status. Getting a “designation” is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Gottlieb said in June that he wanted to get rid of the backlog; on Tuesday, he said the effort was complete. About half of the 200 applications from drugmakers won orphan status.
  • Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with being an orphan. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and, more recently, another by United Therapeutics. The FDA Reauthorization Act, which passed last month, made it law that a drug has to be clinically superior to get the incentives.
  • Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a “first step.” Dr. Bridgette Jones, chair of American Academy of Pediatrics Committee on Drugs, said late Tuesday that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”

Dr. Martin Makary, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Gottlieb seems “concerned about all the right things.”

“The government does a lot of lip service in general,” Makary said. “This is not lip service.”

The restructuring has been swift in some ways.

Sandra Heibel, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”

Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications — ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.

In an emailed note Tuesday, the agency confirmed that Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs — especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.

“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.


This story was produced by Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation. This KHN story also ran on NPR. 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.

Institute for Biomedical Sciences Introduces Innovative Doctoral Program

GSU’s Institute for Biomedical Sciences has welcomed its first class into an innovative interdisciplinary program meant to cultivate the next generation of leaders in the biomedical sector.

from GSU News Hub

The Doctor of Philosophy in Translational Biomedical Sciences degree program at Georgia State University is unique in its interdisciplinary approach, which spans science, business and law. The program offers an educational focus in microbial pathogenesis, infectious disease, vaccinology, immune regulation, cardiovascular and metabolic disease and translational medicine, along with training in entrepreneurship, innovation and commercialization of scientific discoveries through the J. Mack Robinson College of Business and the College of Law. It delivers professional development through a partnership with the College of Business’s Entrepreneurship and Innovation Institute as well as the private sector. Students will conduct research with renowned faculty members in the institute’s advanced research facilities.

Read More →

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.