Tag Archives: fda

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.

Challenging Drugs’ Moonshot Price Tags

Q: Some American pharmaceutical companies are well-known for pricing drugs at whatever the market will bear. In oncology, some specialty drugs seem to have price tags completely unrelated to the proven effectiveness of the drug. Your company has been taking a lead in confronting this problem. What do you envision as possible solutions?

A: New oncology therapies carry astronomical price tags—most people know this. Receiving far less attention is the question of actual therapeutic value. Drug manufacturers spend billions on advertisements and PR, but unfortunately, real-world patient results are frequently unimpressive. Two recent articles in BMJ make this point, 1) No evidence of benefits for popular oncology therapies and 2) Do cancer drugs improve survival or quality of life?

Why do high-cost oncology therapies with questionable results continue to be prescribed? Let’s examine a situation my company is dealing with right now. VIVIO Health received a request for neratinib, an FDA-approved extended adjuvant therapy for early-stage HER2 positive breast cancer. Our system analyzed all available performance data from sources such as the FDA, ICER and NICE. The drug approval was based on a newly created surrogate endpoint called invasive Disease-Free Survival (iDFS), which only scored 94.2% vs. 91.9% in the placebo arm. Even worse, 29% of the patients dropped out of the trial due to adverse side effects, 16.8% for diarrhea alone. Not surprisingly, the FDA committee patient representatives voted against approval.

See also: ‘High-Performance’ Health Innovators  

Neratinib’s manufacturer PUMA Biotechnologies provided data on the current standard of care, trastuzumab, showing a disease-free survival (DFS) rate of 89%. Interestingly, the use of iDFS as an endpoint led to an increase in the placebo arm of ~3%, which is larger than the neratinib-to-placebo arm difference of ~2%. Ultimately the creation of a new endpoint made a larger impact than the therapy itself. The trial design itself had been altered so many times; the FDA suspected the trial had been “unblinded” and attempted to determine statistically whether unblinding had occurred. Even with these highly questionable results, the FDA approved neratinib in July.

After being shown the questionable data and asked, “Why neratinib?” the requesting oncologist explained that it’s an FDA-approved drug and that “MD Anderson is giving it to everyone.”

Granted it’s hard, but physicians should have the courage to do the right thing. In the context of high-dollar, high-tech therapies and billion-dollar windfalls for pharma execs like Puma CEO Alan Auerbach, physicians must be America’s frontline ensuring that only the right therapies get to the right patients. Using neratinib as an example, here are seven steps every physician should consider before prescribing oncology therapies:

  1. Police endpoint games. Don’t allow drug companies to define arbitrary and meaningless endpoints for your patients. Prescribe medications with objective data on meaningful endpoints such as life expectancy. Anything less should be considered experimental at best, and pharma should pay for that.
  2. Do the math. In the case of neratinib, a 2% probability of potential benefit means that for every two patients who might be helped, 98 are subjected to real side effects or other harm. In the neratinib trial, this equates to the “lucky” 33 out of 1,420 total patients, which is quite a needle in the haystack.
  3. Consider the actual cost. Spending $5 million per patient “helped” with such uncertain outcomes makes no sense.
  4. Consider societal opportunity cost. Spending money on therapies that don’t work diverts dollars away from developing therapies that do.
  5. Stop listening to key opinion leaders (KOL). Dig deeper and make your own decision. A KOL’s opinion isn’t data and is too often wrought with conflict.
  6. Require companion tests. Don’t prescribe low-probability therapies without some form of a companion diagnostic and insist that the drug company provide it for you.
  7. Prescribe therapies as if you’re the patient and you’re spending your own money.

See also: U.S. Healthcare: No Simple Insurtech Fix  

Physicians, you hold the key to changing the cost curve for ineffective therapies. Drug companies will get the message when you refuse to prescribe treatments that don’t work and cost too much.

Can Your Health Device Be Hacked?

What seemed like a farfetched scenario out of Hollywood four years ago is now yet another reality that security experts have been warning about.

In the screen version, the U.S. vice president is assassinated on the TV show “Homeland” after a hacker takes control of his pacemaker and stops his heart—making it look like a heart attack.

In real life, the U.S. Food and Drug Administration recently released a safety warning that St. Jude Medical implantable cardiac devices and their remote transmitters contain security vulnerabilities. An unauthorized party could use the vulnerabilities to “modify programming commands” on the device that could result in rapid battery draining or “administration of inappropriate pacing or shocks.”

Coincidentally, the warning came on the heels of an FDA document addressing this very issue: At the end of December, the agency released its guidance for the post-market management of medical device cybersecurity.

The guidance is similar to a previously issued one for premarket design and development. Both are nonbinding.

The FDA can take action against products that violate the Food, Drug and Cosmetic Act, which could include devices that pose serious risks of injury or death and lack remediation. Outside of that, it’s unclear what, if anything, the FDA would do about lower-level risks that are not being mitigated.

See also: Your Social Posts: Hackers Love Them  

Enforcement or not, there’s plenty of skepticism about the influence the document will have on device manufacturers. Security experts call it a good first step—emphasis on “first.”

But they are not convinced that the guidance will motivate the industry to make medical devices more secure.

“Absent of serious crises or patient deaths, I’m not optimistic that this document will get the attention of many companies building medical devices,” says John Dickson, a principal with the security firm Denim Group Ltd., who formerly served at the Air Force Information Warfare Center.

The guidance “emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits as part of their post-market management of medical devices.”

Among other things, the FDA recommends that manufacturers:

  • Follow the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Security, which is widely used in many industries
  • Implement a risk-management program for identifying and assessing vulnerabilities
  • Act on information about vulnerabilities and deploy patches quickly.

A big problem to crack

Dickson says that the sheer number of devices in circulation—potentially millions, registered to some 6,500 to 7,000 manufacturers—creates a major problem.

“Most of the medical device companies are just trying to get the capability to work well—and here comes (a problem) they really didn’t consider before,” he says.

The embedded sensors and devices were designed for a long lifespan and, in many cases, not intended to be upgraded.

“If those devices cannot receive software updates at some time in their lifespan, they will be vulnerable, so the risk is enormous,” says Hamilton Turner, chief technology officer at mobile-security vendor OptioLabs.

The industry has been slow to react.

Ashton Mozano, chief technology officer at Circadence, a “next-generation” provider of cybersecurity training, says that some of the device vulnerabilities have been known for as long as a decade. But the response has not been like in airline or automotive safety, where “there’s a whole community that gets up in arms” when there’s a faulty or dangerous product.

“We don’t really see that in cyberspace yet. The medical device industry, as well as the IoT realm, have been essentially isolated from that level of widespread global scrutiny,” Mozano says.

The FDA began warning about the problem a few years ago. The guidance certainly indicates the agency’s interest in cybersecurity is growing. Unfortunately, the FDA may not be in the best position to address the problem.

“They’re not in the best situation to have the knowledge and skill set … to mandate regulations for the cyber industry,” Mozano says. “They don’t want to overregulate.”

Plenty of gaps to be filled

The FDA defines patient harm as physical injury, damage to health or death. Other types of harm—such as loss of personal health information—is excluded from the FDA’s scope.

Turner thinks that’s an oversight. He says that data taken from a device can sometimes include information about the operating environment, including secure Wi-Fi access that could be used to access the network and cause patient harm.

“Ignoring loss of data in a security context can lead to some very serious repercussions,” he says.

Long-term execution of the guidance also is questionable. Mozano says there needs to be “a clear assignment of roles and responsibilities throughout the entire vertical and horizontal supply chain.” And, there needs to be better leadership and a more systematic, step-by-step implementation, he says.

The FDA could take a page from the automotive industry, where rankings by third-party evaluators such as JD Powers influence buying decisions. This would not only motivate manufacturers to protect their reputation but also put some of the power into the hands of the users.

See also: When Hackers Take the Wheel  

“This could be more effective than having draconian regulations,” Mozano says.

The industry sentiment seems to be that scenarios à la TV’s “Homeland” are still far-fetched. Even the Department of Homeland Security said the vulnerability in St. Jude’s devices would have required “an attacker with high skill.”

But Dickson emphasizes that what was science fiction as recently as two years ago is now becoming a major problem. After all, not too long ago “people said political campaigns were too sophisticated to hack.”

“Given the widespread and ubiquitous nature of medical devices, the fact that a more sophisticated attacker could do this means it will happen at some point,” he says. “As the sophistication goes down the chain, there’ll be more automation to do it. At this point, nobody has figured out how to automatically attack, but that will happen.”

This post originally appeared on ThirdCertainty. It was written by Rodika Tollefson.

5 Breakthrough Healthcare Startups

The 2016 HITLAB Innovators Summit and World Cup was held once again at Columbia University in New York. There were 74 technology companies that entered the competition, and five finalists were selected. All of these startups that entered the competition and others that help sponsor this annual event have the potential to help improve the way healthcare is delivered now and in the future through innovative technologies.

Near Infrared Imaging (NII), based in Wrentham, MA, has developed a technology for the enhanced visualization of veins. This technology, called the Vein-Eye, is a hands-free, non-invasive hospital cart that provides real-time imaging of the veins below the surface of the skin. Michael Feeney, president of Near Infrared Imaging, said, “Vein punctures can be very painful, especially for difficult patients who may be obese, very young, very old and/or have dark skin.” Multiple attempts to puncture a vein result in a very negative experience for both the patient and the provider.

The first specific successful application of the Vein-Eye is varicose vein treatment. The Vein-Eye is also targeting patients receiving dialysis, patients with severe burns, patients with Thalassemia Major Disorder and patients undergoing FLAP surgery, which is a technique involving lifting a tissue from a donor site to a recipient site. Roughly 25% of all patients, regardless of healthcare setting or illness, have delayed care due to the inability of a healthcare provider to establish an IV access to the patient’s vein. NII is also working to develop a patented technology that will detect real-time bleeding in the brain at the scene of the injury.

MedLogiq, based in Hazlet, NJ is bringing technology originally developed and used by the automotive and aviation industries to testing and monitoring product quality and performance in the medical device marketplace. This proven technology comes at a time of increased concerns about product defects in a wide range of medical-devices, resulting in serious injuries to patients and massive product liability lawsuits. The FDA has expressed serious concerns with these adverse events and has significantly increased actions against medical device manufacturers.

See also: 5 Apps That May Transform Healthcare  

Bill Acevedo, the CEO of MedLogiq, said: “Our solution provides value from proof of concept through end of life for medical device manufacturers and any other stakeholder.” Acevedo went on to say; “Medical device manufacturers don’t know what they don’t know.” There are many key questions that need to be asked and independently verified about medical devices. Is there a design defect? Was it built correctly? Is there a potential for patient harm or product liability? What data points are needed for continued monitoring of quality outcomes?

Jim Zerka, CFO, said: “Our main objective is to improve patient care and outcomes by reducing adverse events.” Acevedo closed his presentation by stating that this quality control technology was used by Ford to ensure manufacturing quality of every car coming off their assembly lines worldwide.

MedLogiq, along with their technology partner MAHLE Test Systems, has been granted access to the intellectual property for the generic infusion pump (GIP) from the PRECISE Center at the University of Pennsylvania to integrate their solution as the “maintenance processor” to accurately measure and report device performance. The GIP was built by the PRECISE Center to the FDA specifications to enhance safety monitoring, performance testing and event data recording capabilities for infusion pumps designed to administer fluids and medications to patients in a precise manner.

Green Sun Medical, based in Fort Collins, CO is revolutionizing the treatment of adolescent idiopathic scoliosis (AIS). AIS is a condition resulting from a curvature and rotational deformity of the spine. This condition develops in 3% of children under the age of 16. This results in the incorrect rotation of the spine and creates a prominent rib hump in these children. Most patients are diagnosed because of this rib hump, and when it progresses past 30 degrees they are prescribed a traditional brace. Current braces involve a 40-year-old technology, which is a rigid brace that the child must wear as much as 23 hours a day. Needless to say, these traditional braces are terribly uncomfortable and can create pressure sores, also known as bedsores or pressure ulcers, that can result in severe infections and must be worn until the child becomes skeletally mature. If the condition progresses past 50 degrees, surgical intervention is required, with the average cost exceeding $150,000. In addition, surgical intervention results in a 50% complication rate over the patients’ lifetimes.

This new solution is transforming spinal bracing technology and treatment options for spinal deformities through the use of a comfortable dynamic brace with built-in sensors linked to an iPad that provides physicians and family members comprehensive brace pressure information and compliance data in real time through a “report card.” This report card allows for corrections and adjustments to the brace. This technology will prevent children from the pain and suffering of antiquated braces and prevent needless surgeries.

In addition, Green Sun Medical has created a new dynamic brace to help both adults and children with Kyphosis. Kyphosis is a forward rounding of the back and can result in a much exaggerated and very painful rounding. This can occur to anyone at any age but is most common in elderly women.

Green Sun Medical won the award at the Wilson Sonsini Goodrich & Rosati Medical Device Conference in June 2016 as the #1 new medical device in the U.S.

EarID, based in Cambridge, MA, screens and diagnoses ear infections with higher sensitivity and specificity than existing clinical methods by using new 3D imaging and data analytics on a cloud-based platform. EarID assists in ear infections monitoring and management by minimizing unnecessary antibiotic prescriptions and time lost from work by parents and from school by children. Ear infections are the #3 reason for absence from school by children and most likely cause a parent to also miss work.

See also: AI: The Next Stage in Healthcare  

Anshuman Das, a post-doctoral associate at the MIT Media Lab and MIT Tata Center for Technology+ Design, noted that the primary screening tools for ear infections has not changed since the 1800s, and his research has found that accurate diagnosis of ear infections is not currently met in pediatric care. The current diagnosis of ear infections relies on visual inspection of the eardrum, which is performed by a device called the otoscope, which gives very little quantitative information about the actual health of the ear. EarID overcomes these challenges by integrating the conventional otoscope with a structured illumination system that greatly enhances optical and anatomical information about a patient’s ear drum. In addition, the technology with enhanced diagnostic capabilities helps address the overprescribing of antibiotics, which is a well-known public health crisis. (https://tatacenter.mit.edu/portfolio/earid-smart-ear-imaging/)

UE LIfeSciences, based in Philadelphia, PA, is on a mission to make effective breast cancer screening accessible in the developing world and was the winner of the 2016 World Cup. Matthew Campisi, CTO and co-founder, noted that 50% of the breast cancer diagnosed today is in the developing world, with 70% in the Pacific Rim/Southeast Asia, where two-thirds of cases are first diagnosed in stage 3. The company’s technology is currently being used in India, where the death rate from breast cancer is twice that of the U.S. This technology provides a battery-powered handheld wireless device that can store and send data and is accessible anywhere in the world. It is painless and radiation-free and allows for early detection of breast cancer.

UE Life Sciences’ first product, NoTouch BreastScan, is an FDA-cleared device and in a recent clinical trial detected early stage breast cancer with 87% accuracy. The second product, iBreastExam, is a handheld breast scanner that uses a smart phone as its monitor. The development of this technology was funded by the PA Department of Health to address the fact that 90% of the developing world and millions of women do not have access to breast cancer early detection.

Exhibitors at the HITLAB Summit included several other healthcare technology companies such as AdhereTech, based in New York, which has invented a smart wireless pill bottle. AdhereTech was the winner of the first HITLAB World Cup in 2013. Its “smart” pill bottles are being used by patients in pharmaceutical and research engagements and can collect and send data in real time. This system automatically analyzes information, and, if the patient misses a required dose, he receives customized alerts and targeted interventions by cell phone, text messages, etc. This amazing technology requires zero patient setup and recharges just like a cell phone and lasts as long as 5 years. Josh Stein, the CEO, told me the entire purpose is “to see that patients are taking the correct medication at the right time. This is particularly critical for patients diagnosed with cancer.” (www.adheretech.com)

Citus Health, also based in New York, has created a solution named “Call Bell” to help revolutionize how home infusion companies connect with patients. Melissa Kozak, CEO, told me she invented this technology after spending seven years as an on-call nurse for a home infusion company “to help keep my patients out of the hospital.” Kozak experienced firsthand how home infusion patients often needlessly face tremendous anxiety along with many potential adverse events such as delays in receiving antibiotics, chemotherapy, nutrition etc. when patients’ home infusion care process breaks down. The current system typically involves after-hours call centers that are inefficient and typically provide an answering service, not a certified nursing expert. Call Bell allows patients to get answers quickly in real time to address IV support questions and troubleshooting along with answers to questions like, when will my nurse arrive, or when is my next delivery? In addition, this technology provides home infusion companies with accurate patient home infusion supply counts with vastly improved patient support and communications. Call Bell was designed to address the Holy Grail of healthcare, better patient care and better outcomes at a reduced cost.

See also: Consumer-Friendly Healthcare Model  

It was a real pleasure once again to meet so many amazing people developing state-of-the art solutions for an array of global public health issues through new technology. I wish them all continued success and look forward to the 2017 HITLAB Innovators Summit, Nov. 28 -30, 2017 held once again at Columbia University.

The Next Opioid Epidemic: Fentanyl

Fentanyl has been in the news:

In 2014, it began being reported on the U.S. East Coast that heroin was being laced with fentanyl, creating a combination that is “untenably addictive.”

The Sacramento Bee reported in April that 51 overdoses, including 11 deaths, had been reported thus far in the Sacramento area in 2016; toxicologists tied eight of the deaths directly to fentanyl (watch the short video in the article that describes “death as collateral damage” to the drug dealers interested in market dominance).

Later in April, the L.A. Times reported the issue had migrated to the San Francisco area, where fentanyl pills made to look like Norco were a primary culprit.

The chief health officer in British Columbia proclaimed a Canadian public health emergency because of more than 200 overdose deaths during the first three months of 2016; a large portion of them involved “greenish pills purporting to be OxyContin 80 mg tablets.”

In June, it was confirmed that Prince died from an accidental overdose of fentanyl, unbelievable because he was an outspoken advocate of clean living (from having a “swear jar” to not consuming alcohol)

One of the common threads throughout these stories is China’s involvement. The Wall Street Journal published a front-page article on June 23 titled “China’s Role in U.S. Opioid Crisis.” The opening paragraph sets the stage:

Last spring, Chinese customs agents seized 70 kilograms of the narcotics fentanyl and acetyl fentanyl hidden in a cargo container for Mexico. The synthetic opium-like drugs were so potent that six of the agents became ill after handling them. One fell into a coma.

The article goes on to describe how fentanyl often is disguised as hydrocodone and Xanax on the black market — dangerous drugs by themselves but not nearly as potent or fatal as fentanyl. Because China does not regulate fentanyl or analogs used to create fentanyl, there is a significant financial incentive for the drug dealers — $810 of materials can create 25 grams of fentanyl and yield as much as $800,000 in pills sold on the black market.

See also: Opioids Are the Opiates of the Masses

According to the Canadian Globe’s expose on the issue (an excellent look at the black market), accessing fentanyl can be as easy as “Sign up for an account, choose a method of payment, and receive the package in three to four business days.” Reinforcing the financial model: “A kilogram ordered over the internet – an amount equal in weight to a medium-sized cantaloupe – sells on the street in Calgary for $20 million, making it a drug dealer’s dream.”

So, fentanyl is a problem. It’s 25 to 50 times more potent than morphine. It’s highly addictive. It’s available fairly easily on the black market. And it is prescribed by doctors. Way too often.

Approved by the FDA and on script pads supplied by the DEA, its federal legitimacy adds to the lack of stigma associated with use. Which is one reason why I think Prince could rationalize his use. A doctor likely prescribed it for his chronic pain — and other patients fall into that same trap (with fentanyl and other dangerous prescription drugs).

According to the FDA’s own warnings (as reported on drugs.com):

Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Fentanyl Transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.

See also: How to Help Reverse the Opioid Epidemic  

In my opinion, fentanyl should be used to help people die with dignity during end-of-life care. Period. It’s that dangerous. And yet we see it being prescribed, used and paid for.

Month. After. Month.

If you are prescribing fentanyl: Why?

If you are being prescribed fentanyl: Why?

If you are paying for someone’s fentanyl: Why?

Too many people are overdosing and dying not to ask a simple question: Why?