Tag Archives: Pfizer

Why Big Pharma Lawsuits Don’t Work

Truth-stretching claims made by companies about their products are nothing new — we need only think back to old-school infomercials for some prime examples. When the products in question are prescription drugs, however, the repercussions of product misrepresentation become much more complicated. Because there are a number of regulatory departments designed to root out potentially dangerous substances well before they make their way into patient hands, it seems reasonable to assume that the drugs prescribed to us are safe for their intended uses.

Over the last few decades, the FDA has developed a number of programs designed to speed the drug approval process and more quickly deliver promising new medications to suffering patients. The 1997 Food and Drug Administration Modernization Act included a “fast track” program that allowed qualifying drugs to cut approximately a year off the median development timeline. From one point of view, cutting down the time it takes for new medications to make their way to patients in need of treatment has clear benefits. From another, shortening the review and approval process can lead to less rigorous trials with less time to observe potential side effects and interactions.

Faster approval time also means that pharmaceutical companies can start to profit from their innovations more quickly, which provides another motivator for promoting a more streamlined approval process. In some cases, however, an expedited approval process can lead to complications. Pradaxa, sold without a reversal agent for its blood-thinning effects for at least five years, has contributed to severe bleeding incidents and hundreds of deaths. The drug’s manufacturer, Boehringer Ingelheim, has faced thousands of lawsuits due to the internal bleeding side effects and reached a $650 million settlement in 2014 to resolve roughly 4,000 claims.

See also: The True Face of Opioid Addiction  

There are cases to be made both for and against streamlining the FDA drug approval process, but as the aphorism “first, do no harm” urges, safely treating patients should always be at the core of any system. In the first quarter of 2017 alone, the pharmaceutical and health products industry spent a total of $78 million in lobbying, a $10 million increase from the same period in 2016. This massive spending has allowed large pharmaceutical companies to influence policies and laws, and the leverage that Big Pharma gains through lobbying accounts for one of the pathways allowing drugs with potentially life-threatening side effects to reach the market before they’re fully tested.

In 2001, Pfizer, one of the world’s largest pharmaceutical companies, brought a drug called Bextra to market. Bextra belonged to a new class of painkillers called Cox-2 inhibitors — purportedly safer than generics but with a much higher price tag. The FDA approved the drug to treat arthritis or menstrual cramps but rejected the drug for acute surgical pain (which would require a much higher dosage). Pfizer and its marketing partner Pharmacia pitched Bextra to surgeons and anesthesiologists anyway, and at doses up to twice what the FDA had approved as safe.

Promoting a drug for off-label use is in direct contradiction to the Federal Food, Drug, and Cosmetic Act (FDCA) designed to protect the public by ensuring that pharmaceutical drugs are safe and effective for their intended uses. Unlawfully promoting drugs for unapproved uses constitutes healthcare fraud, which in turn excludes pharmaceutical companies from Medicare/Medicaid. The penalty of Medicare/Medicaid exclusion would result in the disruption of necessary prescriptions to patients, loss of jobs and stock losses for shareholders, while virtually guaranteeing financial collapse. Instead of charging Pfizer with the crime, federal prosecutors charged one of Pfizer’s subsidiaries, Pharmacia & Upjohn Co. Inc.

The resolution ensured that workers at Pfizer who hadn’t engaged in illegal activity wouldn’t be affected, but it also reduced the penalty to Pfizer from federal charges to a criminal fine — Pfizer is effectively still able to sell products through federal programs. The size of the fine (nearly $1.2 billion) pales in comparison to Pfizer’s annual revenue, and Mike Loucks, the federal prosecutor who oversaw the Pfizer investigation, worries that the penalty wasn’t steep enough to deter similar behavior in the future.

Contributing to the current situation are four FDA policies that have created accelerated pathways to approval for new, breakthrough pharmaceutical drugs. For example, the 21st Century Cures Act allows companies, under certain conditions, to provide data summaries and “real world evidence” (such as observational studies, insurance claims data, patient input and anecdotal data) rather than full clinical trial results. The policy prioritizes innovation and expedited approval over public safety, resulting in an overcrowded market of nearly identical drugs backed by less comprehensive research.

See also: Big Opioid Pharma = Big Tobacco?  

The importance of research into new solutions to a growing list of healthcare concerns can’t be discounted, but the priorities of current systems seem to have strayed from their original purpose. With the focus behind many pharmaceuticals developed and marketed today being profitability over safety and efficacy, it’s clear that regulations need to change. The industry requires a greater focus on transparency around quality testing and legislation, as well as the elimination of exploitable policies that allow larger companies to stymie generation of quality, affordable generics. Such a shift has the potential to both reverse rising healthcare costs and improve the quality and accessibility of medication to the public.

Looming Caregiver Crisis in the U.S.

AARP’s Project Catalyst recently released a study in collaboration with HITLAB, the healthcare innovation and technology lab based in New York, that shows a very high family caregiver interest in using new technologies to help care for loved ones (71%), but the actual usage today of technology by caregivers is very low (7%) due to the lack of awareness of viable options and the time challenges involved.

According to Laura Pugliese, deputy director of HITLAB and member of the research team, the study is “a call to action regarding the tremendous challenges facing our society and unpaid family caregivers, who are unsung heroes. We are helping to put together a road map for innovative companies to produce technology products and services in the caregiver marketplace to address unmet needs. We want to find out what works and what doesn’t.”

That is the basic goal of AARP and its partners in Project Catalyst, including the medical researchers at HITLAB. The staggering statistic in this study is that by the year 2020 there will be 117 million Americans (including the aging baby boomers) who will need assistance with daily living and healthcare issues. The problem is that, although 117 million people will be in need of a wide range of assistance, it is projected that only 45 million family members will be available to help care for their loved ones. These family members are not only unpaid, but lose $522 billion in income, according to the study (“Caregivers and Technology: What They Want and Need”).

As a former caregiver for both my mother and father, who served in WWII and who were part of America’s greatest generation, I can’t even begin to share how stressful, time-consuming and emotionally draining the process is and the profound impact it played in both my personal and professional life.

As a caregiver over the span of several years, I became involved in finances, banking, wills, estates, taxes, power of attorney, selling a home, healthcare directives, Social Security, Medicare, Medicaid, senior housing, assisted living, nursing homes, DNR orders (Do Not Resuscitate), doctor appointments, surgery, emergency room visits, hospital stays and end-of-life decisions, in addition to just being a son and a brother. I wouldn’t have it any other way, of course.

The only technology available to me was my cellphone and answering machine, but AARP Project Catalyst has identified nine frontiers for innovative technology companies to address:

  • Medication Management
  • Vital Signs Monitoring
  • Diet and Nutrition
  • Aging With Vitality
  • Healthcare Navigation
  • Social Engagement
  • Physical Fitness
  • Emergency Detection and Response
  • Behavioral and Emotional Health

These nine frontiers certainly identify the key areas of concern of a caregiver. However, as I thought about all the time and effort involved from my own personal experience, what is lacking is overall caregiver support. I was often asked, How is your mom? How is your dad? Nobody ever asked how I was doing.

Nothing can prepare you for this caregiver role. In the middle of intense professional obligations as a vice president with responsibilities to major clients, I had to sell a house, find good doctors, get power of attorney, prepare financial statements, pay bills and find cleaning services while seeing that my parents were getting the best healthcare available at the right time and place and taking all the right medications.

Being a caregiver is at minimum like having a part-time job, unpaid. The AARP/HITLAB study found that on average a caregiver spends 20 hours a week on a wide variety of tasks. From my experience, that is about right on a good week.

I can envision existing and future technologies having the ability to better monitor medication regiments. My father, who suffered from congestive heart failure, a blocked carotid artery, diabetes, arthritis, sleep apnea and other ailments, was given so many medications that I had to work with the hospital pharmacy department to develop a check list of what medications he should be or not be taking, what for, why and how often. I developed a handmade chart on his refrigerator door and put numbers on his prescription drug bottles. My handwritten instructions were take # 1, 2, 6, 8, 10 and 12 in the morning, another set in the afternoon and another set at night. It worked, but I had to do this myself by hand with help of a pharmacist.

Initially, the doctors wanted to amputate my father’s legs due to poor circulation from congestive heart failure, but by getting a second opinion we learned that his cardiologist was prescribing the wrong medications. I got him a new cardiologist and the right medications. A dad whose sons didn’t have our healthcare background and connections would have needlessly lost his legs and his quality of life.

Although there are technologies in use today, the actual usage based on this real world study is only 7%. The ability to monitor vital signs, especially for people with sleep apnea, congestive heart failure and other chronic conditions along with glucose levels for a diabetic can bring both peace of mind to a caregiver and potential lifesaving capabilities for the patient.

This study should be a call to action, and I’m sure there are many potential technologies in the pipeline or on the drawing board. I am also glad that people like AARP and HITLAB and the sponsors of Project Catalyst, including Pfizer, UnitedHealthcare, Medstar Health and the Robert Wood Johnson Foundation, are working on this road map.

Project Catalyst is actually reaching out to caregivers themselves to determine what their needs are and what works and what doesn’t. HITLAB medical researchers literally went to people’s homes to interview them to determine their daily needs and their use of technologies as a caregiver. I believe a very comprehensive list of potential technologies should be developed and tested. I see that healthcare technologies and apps are being developed and tested now to address health monitoring such as vital signs and glucose levels. My fear is that this potential use of technologies will be fragmented and require multiple companies, each addressing one of the nine identified frontiers, and may be cumbersome or expensive.

A major issue will also be the ability of medical providers to monitor these vital health signs and other health issues in real time. In addition, will the health insurance industry, including Medicare and Medicaid, be in position to pay primary healthcare providers for this monitoring?

I would also like to see innovative companies provide a comprehensive list of capabilities to help with all the non-direct healthcare needs of a caregiver, such as selling a home, power of attorney, healthcare directives and finding professional caregivers such as visiting nurses, assisted living and nursing homes.

Stan Kachnowski, chairman at HITLAB, stated; “Our goal is to help bring the best technologies to the caregiver marketplace in order to make a positive impact where the patient (and their caregiver) comes first and profits last.”

AARP and HITLAB plan to continue their research and will conduct a series of pilot programs to test new technologies.

This is something that will eventually affect almost everyone either as a patient, caregiver or both. When doctors say there is no known cure for congestive heart failure, diabetes or Alzheimer’s or other chronic conditions, they mean it.

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The PBM vs. the Drug Manufacturer

In today’s American healthcare system, employers can’t order Lipitor directly from Pfizer fortheir employees. Instead, employers and employees are forced to buy drugs through a middleman, the pharmacy benefits manager (PBM).

Fingers have long been pointed in both directions to blame the other for the high cost of prescription drugs. The PBMs blame the drug manufacturers, and the drug manufacturers blame the PBMs, not unlike two children arguing on the playground.

Eli Lilly, one of the world’s largest drug manufacturers, recently claimed that the average price increase on Humalog, its injectable insulin used to treat diabetes, has only been a modest 1% to 2% annually over the last five years. Tim Walbert, the CEO of small drug manufacturer Horizon Pharmaceuticals, said in a recent interview, that he expects the company’s actual price increases to be 4% or less over the next year.

PBMs, on the other hand, portray the drug manufacturers as greedy price gougers that fail to keep prescriptions costs under control. Anthem, one of the nation’s largest health insurers, works hard to convince its employer clients to leverage the buying process by joining Anthem’s negotiated PBM program with Express Scripts Inc. (ESI) instead of negotiating a direct deal with a PBM. This month, however, Anthem came out swinging, accusing its partner ESI of more than $3 billion in overcharges – all of which were passed along and paid by clients.

Who should the employers believe is at fault? Employers are aware of their prescription benefit bills. They clearly see that costs are escalating at an unprecedented rate. What can they do about the problem? How can they succeed if a buyer as large as Anthem failed for its thousands of employer clients?

Today’s healthcare market only permits employers to buy the employee drugs from two different platforms. They can choose to buy through a PBM partnership (Anthem partnered with ESI) or a large benefits broker’s partnership with a PBM. Secondly, they can choose to work with a consultant for high-level advice and contract directly with a PBM.

Regardless, the employer always gambles that it knows more about the PBM’s 120-page contract, pricing calculations and methodology than Anthem apparently did. It is a monumental sign of the times that Anthem publicly blamed ESI for its failure to contract effectively with the company, leading to overcharges for its clients.

Our healthcare system today is broken by design – not necessity – and virtually everyone in the chain lacks the incentive to fix it. In fact, people are financially motivated to maintain the status quo. Until drugs can be purchased directly from the manufacturers for a direct discounted price, employers are trapped in our national prescription benefit system.