EDITORIAL:
CVS Suicides, Antitrust, and Lawsuits
In the July issue of The Pharmacist Activist, I voiced my concerns about the suicides of CVS pharmacists and technicians in Pennsylvania, and reported on a media investigation of these tragedies and efforts by CVS to suppress information about these events. Because I filed a complaint with the Pennsylvania State Board of Pharmacy regarding the suicides, and their possible relationship to working conditions and the occurrence of prescription errors, I am not at liberty to share information pertinent to the ongoing consideration of my complaint. However, other information can be provided.
Following the televised investigative report by Susan Shapiro of WGAL-TV (NBC) on July 28, a video of the report was widely shared by pharmacists and others on social media. Other media reporters also initiated investigations. Reporter Lucy Albright of LNP Lancaster Online interviewed family members of CVS pharmacists who had recently committed suicide, myself, and others in her report that was published on August 14.
Prior to the media reports about the suicides, CVS did everything possible to suppress information about the deaths of its employees, including threatening other store employees that they were not to discuss the situations. When CVS learned that WGAL had scheduled the airing of its report that included interviews with me and others, it contacted the station in an effort to suppress the report by misrepresenting a brief phone discussion I had with a CVS pharmacist. I was able to quickly clarify the challenge and WGAL aired the report. CVS has not responded to my request that it provide a copy of the recording or transcription of comments they attributed to me. Once CVS realized that it was not able to suppress the report, it provided a lengthy statement in an effort to portray a more positive image for the company (excerpts of which are included in the July issue of this newsletter).
Lucy Albright's subsequent report in LNP included some additional observations from a CVS spokesperson. She said the company was "heartbroken" by the deaths of the Pennsylvania pharmacy employees and referred to them as "trusted professionals, respected coworkers and cherished members of our CVS family." The same company that initially attempted to suppress any information about the suicides of its employees exposes its blatant hypocrisy by claiming it is "heartbroken" when it is faced with anticipated unfavorable publicity. The pharmacy employees whose deaths CVS was not initially willing to acknowledge are now designated as "cherished members of our CVS family." The spokesperson stated that CVS won't speculate on the circumstances around the deaths out of respect for the deceased and their loved ones, but then expressed concern about "others using these individuals and their families to advance personal agendas." My initial thought in reading this was to question, "who would ever use suicide victims and their families to advance a personal agenda?" I quickly realized that this comment was directed at me, and that it was CVS which thought of this "strategy" to divert attention from its own agenda of not wanting to even voice remorse or sympathy upon the deaths of its employees to the point of threatening its other employees to not discuss the situations.
To be continued….
Antitrust
The Federal Trade Commission (FTC) presumably continues to have pending antitrust actions against CVS/Caremark, Express Scripts, and Optum (and their affiliated health insurance and other companies) for monopolistic and anticompetitive actions. The bankruptcy of Rite Aid and the closure/sale of all its stores have resulted in CVS purchasing some of the stores, as well as the prescription files of a large majority of the more than 1000 Rite Aid stores that were closed. In addition to greater chaos created in the CVS stores to which prescriptions from closed Rite Aids were transferred, these acquisitions would seem to extend the monopolistic and anticompetitive position that many feel CVS already had. If Rite Aid had not declared bankruptcy and CVS had attempted to purchase about two-thirds of its stores, it is likely that antitrust challenges would have been raised. However, the purchase by CVS of a similar number of prescription records and some stores as a consequence of bankruptcy proceedings has not appeared to even raise questions, let alone challenges.
Other legal challenges, however, have occurred. Rite Aid debtors have sued CVS Caremark for anticompetitive behavior by charging Rite Aid an estimated $500 million over the last 6 years in "clawback" penalties (direct and indirect remuneration [DIR] fees) that were imposed long after the prescriptions were dispensed. The complaint also alleges that CVS violated antitrust laws by requiring Rite Aid to accept "take it or leave it" contracts, a charge that could triple the $500 million repayment that is requested.
Other lawsuits
Omnicare is the long-term pharmacy subsidiary owned by CVS. In recent years, it has agreed to settlements totaling several hundred million dollars to resolve allegations that it accepted kickbacks from pharmaceutical manufacturers, provided improper financial incentives to nursing homes, and improperly billed Medicare and Medicaid. A whistleblower filed a lawsuit alleging that Omnicare had improperly billed Medicare, Medicaid, and TRICARE by dispensing medications without valid prescriptions or refills. In July, a federal judge ordered Omnicare to pay $949 million in penalties and damages (including tripled damages). A component of the Omnicare/CVS "defense" was that there was no documentation that any patients had been harmed, as if that should permit them to escape repayment and penalties of millions of dollars received from improper claims.
Although CVS has the financial resources to pay the $949 million in penalties and damages, it issued a press release on September 22 to announce that Omnicare is initiating voluntary Chapter 11 proceedings, with the intent to use the bankruptcy process "to implement a standalone restructuring or sale strategy." Its statement also notes that it "remains focused on delivering safe and reliable pharmacy services to all customers."
This is blatant deception! CVS gives no priority to the quality of services for its customers or the safety and welfare of its own store employees. It should not be permitted to escape its responsibilities with respect to its violations by using the bankruptcy process.
CVS stores
The CVS stores that have received the prescriptions that have been transferred from Rite Aids that have closed are even more overwhelmed than usual. Management claims that it is providing more staffing but only provides selected information that suits its purposes but is misleading. For example, in response to the concerns about the suicides of the CVS pharmacists in my community of Lancaster, PA, CVS noted that "to help support our teams, we've hired more than 1,500 team members in Pennsylvania this year, including nearly 50 in the Lancaster area." I, as well as the local reporters conducting investigations, asked the following questions:
"How many of the new hires are pharmacists and how many are pharmacy technicians?"
"How many of the numbers of more than 1,500 and nearly 50 represent NEW positions, and how many of the new hires are considered replacements for employees who have retired or are no longer with CVS for other reasons?"
CVS has not even had the courtesy to respond to these questions to clarify the numbers which it chose to provide. Its self-serving messages are not credible. What don't they want us to know? Are they in violation of technician to pharmacist ratios?
In the meantime, the peak immunization season has arrived and the in-store employees are being urged to aggressively promote immunizations. And more errors are occurring!
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EDITORIAL:
Does the Use of Acetaminophen During Pregnancy Increase the Risk of Autism?Data are Conflicting! Is it Possible to Determine a Definitive Answer?
The causative factor(s) and the pathology of autism continue to be poorly understood, notwithstanding the significantly increased incidence with which it has been diagnosed. One reason for the increased number of reports of autism is that a group of conditions with seemingly related neurologic symptoms that have previously been identified by different designations (e.g., Asperger's disorder) are now included under the broader designation "autism" or "autism spectrum disorder (ASD)."
Most of the risk for autism is thought to be caused by genetic factors that include inherited gene variants from parents and spontaneous mutations that occur during conception. Genetic factors may interact with environmental and other influencers such as medications used during pregnancy, air pollution, and certain underlying medical problems. The prevalence of autism is higher in younger children with an estimated 1 in 31 children diagnosed by age 8. Symptoms vary from mild and well managed to severe and disabling. Although the prevalence has increased significantly in recent years, there has been very little progress in identifying the genetic and other factors that cause or increase the risk of autism.
The recent statements by President Trump and the Food and Drug Administration (FDA) regarding a possible association between autism and acetaminophen use during pregnancy have generated extensive publicity and questions. President Trump's statement, "If you're pregnant, do not take Tylenol," was tempered somewhat by the FDA press release of September 22 that acknowledges that the results of studies regarding an association are conflicting.
The FDA statement identifies several studies that have suggested "a correlation between acetaminophen use during pregnancy and subsequent diagnosis of conditions like autism and ADHD." However, it also notes that "a causal relationship has not been established and there are contrary studies in the scientific literature." The press release also announces the initiation of a process for changing the labeling of acetaminophen to increase the awareness of parents and health professionals of the potential risks, while observing that "the choice still belongs to parents."
Acetaminophen experience
Also known by designations such as paracetamol, APAP, and brand names such as Tylenol, acetaminophen is the most widely used medication in the U.S. and many other countries. It is effective in the treatment of mild to moderate pain and in reducing elevated body temperature and, when used in recommended dosages, is considered to be one of the safest medications available. Indeed, its safety profile, compared with products such as ibuprofen, naproxen, and aspirin, has been considered sufficiently favorable that it is recommended as the preferred drug for treating pain or fever during pregnancy and in young children. It is reasonable to conclude that a large majority of pregnant women have taken acetaminophen during pregnancy and that a large majority of young children have been treated with it
Acetaminophen and autism
There have not been any recent studies or other events that have definitively identified an association between autism and use of acetaminophen during pregnancy. Rather, the current attention and proposal to revise the labeling have resulted from the increased concerns about the incidence of autism and the number of studies and questions relevant to acetaminophen use during pregnancy that provide conflicting data and opinions. Some of these studies have suggested a possible association, correlation, or relationship, but have not established a causal relationship (i.e., using acetaminophen during pregnancy has not been determined to be a causative factor in the occurrence of autism). Other studies have not suggested a possible association and the prevailing view continues to be that acetaminophen can be safely used during pregnancy.
The incidence of autism (1 in 31 children at age 8) is an important concern and it would be of great value to determine whether the use of acetaminophen during pregnancy is a risk factor. However, given the frequency with which acetaminophen, as the only nonprescription analgesic/antipyretic that has been recommended for use during pregnancy, is used during pregnancy, a question exists as to whether studies can be designed that would conclusively establish its safety, or lack thereof.
For example, if a study conducted in children diagnosed with autism could determine whether their mothers used acetaminophen during pregnancy, I would expect that a high percentage of these mothers used the medication, and that this information could be used to suggest an association between the medication and the disorder. However, I would also expect that a high percentage of mothers whose children did not experience symptoms of autism would also have used acetaminophen during pregnancy, and that this information could be used to suggest that there is no association between the medication and the disorder. The approximate numbers that are available would also favor the opinion that there is no association. An incidence of autism of 1 in 31 young children (i.e., about 3%), as concerning and important as that is, also means that approximately 97% of children do not have symptoms of autism. In one study, it was estimated that approximately two-thirds of pregnant women took acetaminophen during pregnancy. Thus, the number of children in whom there is no association between the drug and the disorder far exceeds the small number of children in whom an association might be considered to exist.
This reasoning should not discourage those with expertise in designing studies from persisting in investigations that would provide more definitive information than is now available. However, I don't anticipate that more definitive information with which most will concur will be identified.
Is revised acetaminophen labeling necessary?
In the absence of recent and more definitive information that would clarify any relationship between the use of acetaminophen in pregnancy and the occurrence of autism, I do not consider it necessary or advisable to add cautionary information to the labeling. The statement from the FDA provides a sufficient assessment of the information currently available, and also provides context that balances the statement made by President Trump. The addition of cautionary information to the labeling may be potentially confusing and might be misused by some to support a view that there is a causal relationship between acetaminophen use during pregnancy and the occurrence of autism.
Opportunities for health professionals
The FDA statement notes "the choice still belongs to parents," and this is consistent with its emphasis on shared clinical decision-making in discussions with a health professional. For these discussions to be of greatest benefit, they should not be limited to just a consideration of available information. Patients/parents expect pharmacists and other health professionals to have expertise regarding medications and health issues, and value the recommendations we can provide. Even for questions for which there is not a definitive answer, we should not hesitate to share our best professional judgment as we would for a member of our own family.
The occurrence of persistent pain and/or fever during pregnancy may be associated with potential complications. In some situations, the symptoms may be urgent or severe enough to warrant referral to a physician or emergency department. However, in most circumstances in which pregnant women experience pain and/or fever, I will not hesitate to continue to recommend acetaminophen to provide relief of symptoms. I consider the prompt relief of symptoms and the avoidance of possibly resultant anxiety to be of far greater importance than the potential for a risk that has not been clearly established.
Bonus question:
What is the origin of the name Tylenol?
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