Recent Recap for Week Ending 10/31

Executives

Jeff Bezos has led a consumer goods retail revolution through his company, online giant Amazon. Could pharma be his next step? In the midst of reports that Amazon is reaching out to PBMs, some are hopeful that Bezos’s combination of experience, capital, and vision are what is needed to revolutionize the healthcare sector.

The pharmaceutical drugmaker Merck & Co is no longer developing drug treatments for chronic hepatitis C, a liver disease that can lead to reduced organ functioning or liver failure. Rising pressure from competitors, a shrinking patient population, and the results from mid-stage trial data were factors in the company’s decision to halt development.

Humana’s CEO, Bruce Broussard, highlights areas of healthcare that need changes to improve care and lower costs. According to Broussard, the former “siloed” way of organizing healthcare needs to be integrated to focus not only on episodes of patient need, but a more holistic approach to patient care. The three-pronged approach that Humana will take to achieve this goal involves partnering with providers to help manage patient care before problems arise, integrating lifestyle into the holistic approach, and reducing “friction points” for customers by increasing technology advances to ensure the system runs more smoothly.

The White House Opioid Commission, headed by NJ Gov Chris Christie, has announced a partnership with the private sector to investigate the opioid epidemic. The group will focus on finding less addictive painkillers, overdose reversal drugs, and new ways of treating addiction.

The DOJ’s Pilot Program for penalty reduction and declinations does not include pre-existing compliance. A high ranking DOJ official said, anecdotally, that the omission is nothing more than an oversight- which is easily fixable. Investment in pre-existing compliance has long been the most effective way to prevent corruption, so it has good reason to be included in the program.

Big Pharma has been the target of FDA inspection for quite some time now, and after tens of billions in fines, it seems to have gotten the message that compliance will be taken seriously by the federal government. Small pharma, however, seems to be skating under the radar; they are building up revenue and sacrificing compliance. Will the DOJ set its sights on these smaller firms next?

A liberal advocacy group, Public Citizens, wants the Food and Drug Administration (FDA) to act on its petition to regulate over-the-counter oral health-care products that contain benzocaine, an ingredient commonly used to treat teething pain. The group claims that the FDA has known for years that benzocaine is associated with the life-threatening blood disorder, methemoglobinemia, which negatively interferes with the body’s ability to use oxygen. The group reports that cases of benzocaine-related methemoglobinemia have been reported in young children.

Medical Devices

Unfamiliar plant investigators are preferred over recurring investigators during manufacturing facility inspections. Manufacturing recalls are highly predictive when a first time FDA investigator inspects a plant. Investigators already familiar with the plant can be biased, complacent, and even lax when it comes to enforcing standards, thereby increasing the chance that a manufacturing facility will face compliance issues in the future.

A study has found that FDA inspections of medical device manufacturing plants is a good indicator of future recalls. The best way to prevent recalls, according to the research, is for frequent FDA inspections to be conducted by a fresh set of eyes. Sending someone unfamiliar with the plant is more effective for inspections.

The United States Congress recently passed the Medical Device User Fee Amendments (MDUFA) bill that will require medical device companies to pay higher application fees for de novo device classifications. Michael Drues, a regulatory consultant based outside of Boston, expressed concerns that the new user fees may stifle or kill innovation.

Promotional

More than half of polled Democrats and Republicans receive updates from general news outlets but less than a third of Americans believe that the news they read is scientifically sound. Republicans are seemingly skeptical about the quality of science coverage in the news media and Democrats are more likely to agree with the ways the news media is featuring the latest scientific reports. Democrats and Republicans alike feel that the way scientific research is reviewed and presented to the public is more of a problem than the actual ways scientists publish their findings in academic journals.

The FDA has recently issued a warning letter to the maker of Dynavision D2 for language on its website describing unapproved applications for the device. Regulatory affairs should be monitoring website content to ensure that companies can avoid these types of warnings.

NJ Governor Chris Christie, who is also the head of the White House Opioid Commission, said that pharma companies paid prescribers in NJ about $69 million in gifts. Christie says that the money has an undue influence in prescriber’s decisions. Two thirds of that money went to just 300 doctors. The proposed bill would limit gifts to the amount of $10,000 annually.

Pricing, Reimbursement and Medical Affairs

Insurers and pharmacy benefit managers are implementing new constraints on a patient’s ability to purchase new cholesterol-lowering drugs. Doctors are now required to send pharmacies pre-approval even for patients that are dependent on cholesterol-lowering medications. Astronomical out-of-pocket costs are a major deterrent. An overwhelming majority of patients needing cholesterol-lowering medications are hesitant to fill their scripts.

  • An Op-Ed Ghostwriter Speaks

Ghostwriting is a responsible form of communication that effectively translates the viewpoints of credible authorities into comprehensible thoughts. Ghostwriters consider themselves mediators between professionals and the larger audience, and work as collaborators in spreading news to an otherwise uninformed public. Contacting the source of their stories for clarification or accuracy begins to make other writers question the writer’s competence and talent.

When physician certification boards were established in the early twentieth century, their purpose was clear and they were badly needed to ensure patient trust. Some doctors have lamented the expensive process by which they must maintain their certifications. Now, after scandals involving financial impropriety, physicians should consider their role in holding the certifying boards accountable.

Clinical Trials

The FDA and HHS have followed up on earlier draft guidance for documenting IRB activities. The final guidance clarifies some of the questions arising from the draft, including what information must be included in the minutes. It also clarifies the regulations for reviewing research in children.

Some minority and other underserved populations are distrustful of clinical trials because they fear becoming experimental subjects. An precision medicine campaign from the NIH is seeking to change this perception. They have been embraced by the family of Henrietta Lacks, a black woman whose cervical tissue was used without her consent-and about whom a movie has been made.

Speaking before an audience from the National Academies of Science, Engineering, and Medicine, the FDA’s Director for Evaluation and Research said that the clinical trials system is “broken”. She said that future trials should be designed according to “master protocols”, which collect data for multiple diseases under one therapy, or multiple therapies for a treatment. She spoke positively about the inclusion of Real World Evidence (RWE) into the clinical trials system, but said that it has the potential to introduce biases.

Manufacturing

The FDA has developed draft guidance for the generics industry on priority reviews, in what the industry is calling a “fundamental departure” from the terms agreed upon in user fee negotiations. The industry says that the guidance is self-defeating and will inhibit generic drugs from coming to market.

The FDA has recently warned Chinese drug manufacturer Shandong Vianor Biotech regarding failing lots of material reported as acceptable. In addition to falsifying test results, the company reportedly blocked FDA inspectors.

Pharmacy

Compounding pharmacies are encouraged to register with the FDA under the Drug Qualities and Securities Act (DQSA). To date, only 70 out of approximately 7500 compounding pharmacies in the US have registered. The pharmacy lobby, APhA, has taken issue with the FDA’s request because compounding pharmacies have been traditionally overseen by states.

  • CVS Health unveils new PBM, pharmacy efforts to curb opioid abuse

Balancing the need for opioid in treating pain with the potential for abuse, CVS will start with a drug counseling program for patients filling opioid prescriptions. The pharmacy recognizes its role in education patients about the potential risks of abuse.

Reports of Amazon’s interest in the pharmaceutical market are growing. There have been confirmed meetings between Amazon managers and PBM specialists, sparking both curiosity and concern of how the e-commerce giant will influence prescription drug distribution. Some say that Amazon is not suited to break into such a highly regulated market, but others cite the company’s proven innovation and leadership as proof that they will be successful if they want to be.

Medical Marijuana

NJ’s medical marijuana community is led by Dr. Andrew Medvedovsky, a board certified neurologist who does not like the stigma that comes with the phrase “Pot Doc”. He has recommended medical marijuana prescriptions to over 3000 patients who suffer from chronic pain, and he teaches nursing students about the potential of medical marijuana.

Following a controversial drug bust on a group of mothers growing marijuana to help sick children, the Peruvian president Pedro Pablo Kuczynski proposed legislation to legalize medical marijuana. Most Peruvians are in favor of legalizing the drug for medical purposes.

A pharmacist from Plumas County, California, explains his opinion that CBD, a chemical component of marijuana that is less psychoactive than THC and has better painkilling properties, could be a good alternative to opioids. Plumas County has been heavily affected by both death from opioid use and violence associated with the illegal drug trade.

Privacy and Cybersecurity

After a summer of seemingly back to back cyber attacks, the Office of the Inspector General will be looking into federal cybersecurity. Specifically, the agency will look at the Department Health and Human Service’s preparedness for future attacks.

Employers have an interest in making sure their employees are healthy and fit, and one of the best ways to encourage that is through exercise programs. To that end, Fujitsu has purchased Fitbits for its employees. The company is instituting an employee wellness program to encourage health and well being.

Medicine is slow to adopt the electronic payment systems used in nearly every other industry. Concerns about HIPAA compliance and unauthorized debits to retrieve funds have held back implementation of electronic payment systems.

Futurism

A 3D printer developed by researchers at the University of Minnesota is able to print bio-ink directly onto a moving body. The printer can sense movement and recalibrate itself to the new position in order to ensure that the material is printed in the precise location of the target.

Researchers in France stimulated the vagus nerve of a man who had been in a vegetative state for 15 years. After a month of nerve stimulation, he was able to demonstrate some conscious behavior and move his body in response to outside conditions. He was able to stay awake for longer and appeared conscious of an invasion of space.

A walking nanorobot with “arms” and “legs” designed by researchers at Caltech may help deliver drugs to specific locations in the body. Its very small size allows the robot to travel through the bloodstream to a specific location. Lulu Qian, who is a professor involved in the research, hopes the robots can be useful in disease treatment.

Food

The FDA is responsible for ensuring the safety of the food supply, as well as preventing fraudulently labeled foods from being sold in the US. To that end, companies importing food products into the US must take care to ensure the accuracy of the labels. Violations may result in warnings or even recalls.

Consumers increasingly want to know what is in their food, and the new “C.L.E.A.N.” and “R.A.W.” labels will help that effort. The labels denote foods which have been minimally processed, and are therefore healthier because they retain more of their nutritional value. The labels are voluntary, and have so far been embraced by health food brands.

In May 2016, the FDA announced that it will require nutrition labels to disclose the amount of added sugar in food. Now, the deadline has been pushed back from July 2018 to January 2020, in a move that seems to appease food lobbyists who say the new label will be too expensive. Many companies have begun adding the new information already, adding to criticism that the FDA’s delay is unnecessary and harmful to public health.

Cosmetics

An employee has filed a lawsuit against Estee Lauder, accusing the company of having inequitable parental leave policies for its male and female employees. Like many companies, the cosmetics giant asks the parent to designate “primary” or“secondary” caregiver status to him/herself, rather than assigning the leave based on gender role.

Tess Holliday, a model and outspoken advocate for body positivity, is calling for better representation of people of all sizes, shapes, and races in future cosmetics and fashion ads. She says that while the industry has made improvements, much work remains to be done in order for more women to see people who look like them in cosmetic ads. She talks about how her activism on the issue influences her career.

Beautycon, a festival that describes itself as a cross between Coachella and Sephora, took place in LA recently and attracted more than twenty thousand attendees. Many were young, as millennials now make up the majority of that industry’s consumer base. Organizers focused on millennials’ preference for conscious consumerism- a trend which many companies should consider emulating to remain competitive with millennial consumers.

Bioethics

Pro-life advocates have long taken issue with fetal tissue research, but it is currently legal under specific circumstances. It is used in research related to Parkinson’s disease, paralysis, and other conditions which depend on the ability to regenerate neural tissue. Proponents of the research say it is still badly needed and should remain legal.

Conventional wisdom tells us that corruption or unethical behavior comes from the top down, setting a toxic climate for all. However, new research shows that some middle managers struggle to maintain their ethics when tasked with unrealistic goals. They may drive subordinates into unethical behavior, or inflate evaluations of their performance to appease upper managers.

Nigerians struggle to maintain rule of law and justice in a government system that is plagued by corruption. Allegedly, the director of the Nigerian National Petroleum Corporation (NNPC) has acquired contracts worth more than $25 billion. The author questions the moral climate of his country and government that has led to such an egregious and greedy crime.

Patient Advocacy

The US Department of Justice has initiated a probe into Patient Services Inc (PSI) for its role in helping patients with co-pays for Juxtapid, Aegerion’s expensive cholesterol drug. Aegerion has already been fined by the FDA for inappropriately marketing the drug to unapproved patients. PSI says that the probe is just part of a general investigation by the government into pharma charities.

The city of Seattle and Washington state have named several major pharma companies in lawsuits related to the sale of opioid painkillers. They say that the companies downplayed the risk of addiction and the debilitating nature of the drugs, while overstating the efficacy for treating pain. The companies say that they acted within the laws and that the case is preempted by FDA rulings, and should therefore be thrown out.

Personal technology is everywhere these days, from online shopping to researching health conditions. Physicians can leverage these tools to help patients maintain their health between appointments, as well as manage chronic conditions outside of the doctor’s office.