“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
MISSION: The Mission of the Office of Civil Rights is to ensure equal employment opportunities for all applicants and employees, to promote a professional work environment free from discrimination and harassment, and to conduct training and timely investigations in compliance with civil rights laws and CDCR policy.
The U.S. Department of Veterans Affairs and CVS Health lead the list of providers receiving the most privacy complaints that resulted in corrective-action plans or technical assistance provided by the Office for Civil Rights (OCR) from 2011 to 2014, according to a report from ProPublica.
Some fines are issued by federal government to medical providers for violating the privacy and security of patients’ medical information in the Health Insurance Portability and Accountability Act (HIPAA), and the OCR will issue press releases and post details on the web.
But thousands of times a year, the OCR resolves complaints about possible HIPAA violations outside public view, according to ProPublica. The OCR sends private letters reminding providers of their legal obligations, advising them how to fix problems, and, in some cases, suggesting they make voluntary changes.
ProPublica also published a tool it calls HIPAA Helper that makes public 300 of these closure letters.
With the tool, the public can see details of these cases and discover repeat offenders. The letters were obtained the by ProPublica by requests to OCR under the Freedom of Information Act.
In contrast, when federal officials take the less frequent step of fining medical providers for violating the privacy and security of patients’ medical information, they publish press release and posts details on the web.
In 2014, the most recent year for which data is available, OCR received more than 17,000 complaints, as well as tens of thousands of self-reported breaches of medical information.
“Most of the letters we’ve received were sent to two large providers, the U.S. Department of Veterans Affairs and CVS Health,” ProPublica reported. “But there are also notices of privacy violations sent to Kaiser Permanente, Planned Parenthood and the Military Health System.”
Both the VA and CVS received more than 200 privacy complaints that resulted in corrective-action plans or “technical assistance” being provided by the OCR from 2011 to 2014, ProPublica said.
CVS Health and the VA said in a statement to ProPublica that they are committed to protecting patient privacy.
Statement of FDA Mission FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability.
Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record.Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.
There have been exclusions for 6 plants in India, including one operated by Canada’s Apotex and one by Wockhardt, an Indian company that has run into numerous FDA citations. The exempted facilities also include a Teva ($TEVA) plant in Hungary and a plant operated by China’s Zhejiang Hisun Pharmaceutical. The drugmakers have all indicated they take quality seriously and are working closely with the FDA to resolve their issues.
The agency this year found itself having to backtrack in the case of Hisun when it determined there was a shortage of a chemo drug often used to treat AIDS-related Kaposi’s sarcoma. The agency in September 2015, banned 15 drugs coming out of the Zhejiang Hisun because of “systemic data manipulation” in the facility. At the time, it excluded tuberculosis treatment capreomycin and 13 others over concerns that shortages might arise. Then in February it updated the order to also exclude daunorubicin HCl, the API used in the injected med DaunoXome because of a “critical drug shortage concern.”
In the case of the Teva plant, the FDA last month issued an import alert for all but two products at the Teva facility in Gödöllő: cancer treatment bleomycin and antibiotic amikacin.
The FDA will not address specific cases but has said that when it exempts certain drugs from an import alert due to shortage concerns, it “also often requests the manufacturer to take certain measures to enhance quality oversight for products that are offered for entry into the United States.”
But as Bloomberg points out, the FDA leaves that testing up to any drugmaker that buys the exempted ingredients. “There is no transparency,” Erin Fox told Bloomberg. Fox is director of the University of Utah’s Drug Information Service, which tracks drug shortages. “We just have to take FDA’s word that they think it’s OK.”
The FDA learned the hard way that it must sometimes balance the need for demanding companies’ GMP compliance and patients having access to needed drugs. It came under intense criticism in Congress some years back, when shortages arose after companies stopped production in some plants to address FDA citations.
It faced a particularly daunting situation in 2013 with the Boehringer Ingelheim Ben Venue plant Bedford, OH, a facility with deep-seated problems that had been responsible for dozens of recalls. But because the sterile injectable drug facility at the time was the only source for so many products, when it came time to lay out its mandates under a consent decree, the FDA allowed it to keep producing about 100 drugs considered “essential for patient care.”
Boehringer Ingelheim in 2013 finally decided to simply close the plant, leaving many drugmakers to scramble for production alternatives to keep drugs available. Johnson & Johnson’s ($JNJ) Janssen’s unit, which had dealt with supply issues for its popular breast cancer treatment Doxil, went so far as to get FDA approval to lease part of the Ben Venue plant and produce the drug there itself until it could arrange for another supplier.
One medical facility is already feeling the fallout from the suspension, announced Tuesday, of a Durango doctor’s medical license.
Southern Rockies Addiction Treatment Services fielded multiple calls Thursday from patients who received prescriptions from Dr. Deborah Parr for assistance with substance addiction, said Sara Carver, director of clinical operations for the organization. “We started getting calls from her clients saying: ‘Oh my gosh, my doctor lost her license, and I need my medication. Can you help me?’”
Parr, a psychiatrist, is one of four doctors in Colorado whose license was suspended for allegedly recommending higher-than-normal marijuana plant counts to hundreds of patients. But those clients represent only a part of her practice, Carver said.
“Losing her medical license, even temporarily, means the addiction-treatment clients she sees are suddenly without their medication,” Carver said.
Unlike patients who were prescribed marijuana, there is not a readily available alternative to substance-abuse patients’ prescribed medications such as Suboxone, which is used to treat narcotic addictions, she said.
Carver also expressed concern about Parr’s history of prescribing opiate-based medications to individuals with histories of substance abuse.
“We are bracing ourselves for more inquiries today (Thursday), and fear that her questionable prescribing practices spill over into her prescribing practices in addiction treatment as well,” Carver said.
Southern Rockies Addiction Treatment, which treats about 100 clients, is booking intake sessions through next week to try to accommodate the increased call volume from Parr’s patients, said Daniel Caplin, the physician who runs the practice.
While Caplin’s practice is experiencing the brunt of the calls, there is potential that the emergency room at Mercy Regional Medical Center and detox of La Plata County also could be affected if individuals’ prescriptions lapse from not contacting a physician, he said.
La Plata County residents should be aware of issues surrounding substance abuse, said Stephanie Allred, senior director of clinical services for Axis Health.
“It’s a problem everywhere, and when people have mental health conditions, there are a lot of people who have co-occurring substance-abuse disorders,” Allred said.
When mental health conditions are not addressed, there is a tendency for self-medication, which can serve as the basis for a substance-abuse disorder or lead to relapsing.
To help individuals who are experiencing a substance-abuse crisis, Axis Health, which runs the detox center, offers a 24-hour hotline, said Sarada Leavenworth, senior director of strategy development and communications. “It can be critical for folks to have a way to reach someone who’s specialized in these questions and can supply support.”
Axis’ 24-hour hotline can be reached at 247-5245.
Luke Perkins is a student at Fort Lewis College and an intern at The Durango Herald. He can be reached at lukep@durangoherald.com.
When John Kennedy was sworn in as our 35th President.. our national debt was abt 300 BILLION
When Pres Obama took office in 2009 as our 44th President…our national debt was abt 12 TRILLION and his quote about us as a nation was:
“We are going to have to change our conversation; we’re going to have to change our traditions, our history; we’re going to have to move into a different place as a nation.”
As Pres Obama leaves office our national debt is approaching TWENTY TRILLION…
In each year of his Presidency … him and Congress increased our national debt abt THREE TIMES EACH YEAR what the first 34 Presidents amassed COLLECTIVELY.
If you are voting to see what your country can do for you…then the next chapter in our country history may follow the path of Cuba, Greece and Venezuela and/or other countries that have went down socialism’s path..
There is probably no other organization in American pharmacy that can match CVS with respect to the opportunity for having a strongly positive impact on the practice of pharmacy. It has approximately 10,000 pharmacies and extensive financial resources. It has thousands of highly capable pharmacists. Its leadership deserves credit for certain of the decisions that have been responsible for its growth and financial success. It has received accolades for its excellent decision to discontinue the sale of tobacco products.
But then I am pulled back to reality by headlines such as the following that appeared in the June 30th issue of The Boston Globe (Vivian Wang):
“CVS pays $3.5m to settle claims it filled fake painkiller prescriptions”
The story reports on allegations by DEA investigators that pharmacists in 50 CVS stores in Massachusetts and New Hampshire dispensed forged prescriptions more than 500 times. CVS responded by agreeing to settle the claims for $3.5m and to improve training of employees to recognize forged prescriptions. It said that it settled the allegations to avoid the cost and inconvenience of further legal proceedings. Apparently $3.5m buys the conclusion of the investigation, but many questions remain such as the following:
Are the pharmacists about whom the allegations were made still employed at CVS? If so, did they receive any disciplinary action? Have any of the alleged actions been reported to the State Board of Pharmacy? If so, did the Board take disciplinary action? If it was an owner of an independent pharmacy against whom such allegations were made, it could be anticipated that her/his pharmacist license might be suspended and that the subsequent ramifications might necessitate sale or closure of the pharmacy. There is a gross inequity with respect to the consequences that an owner of an independent pharmacy might experience when compared with those of a chain pharmacist and her/his company. This inequity can be defined by the number of dollars it takes to settle the allegations.
I wish to be clear that I deplore every situation in which a pharmacist betrays the public and our profession by dispensing prescriptions that he/she knows or strongly suspects are forged. However, to what extent does a company’s policies, culture, and work environment contribute to situations in which pharmacists make bad decisions? Related questions include: When a prescription is received, is there a specific period of time in which a pharmacist is expected to complete and dispense it? What are CVS’s expectations (quotas) regarding the number of prescriptions that must be dispensed before additional staffing (pharmacists and/or technicians) is provided? Is the number of prescriptions dispensed a factor in the determination of bonuses for pharmacists? What are CVS’s policies and procedures with respect to how its pharmacists should respond when they suspect a prescription is forged? For example, should the prescriber identified on the prescription be contacted to confirm that it is valid? Should the police be contacted when it is known that a prescription is forged? When a pharmacist declines to dispense a prescription, do the policies and procedures keep the potential for retaliation at the lowest level possible? There is no reason to think that these questions were even considered by the DEA and/or other investigators. Reaching the settlement was apparently based only on dollars.
I raise these questions because I consider them very important, and not to make excuses for bad decisions of pharmacists. Pharmacists must give the highest priority to their responsibilities to their patients and to the laws and ethics of our profession, and must not use company policies and/or pressure as an excuse for compromise or inappropriate actions. It is noteworthy that a CVS pharmacist with a physician who is CVS’s medical director have published an article in the New England Journal of Medicine (August 21, 2013) titled, “Abusive Prescribing of Controlled Substances – A Pharmacy Review.” However, to my knowledge, CVS has been silent about the problems that have been identified in its own pharmacies. A title for such an article might be, “Abusive Dispensing of Controlled Substances – The CVS Experience.”
Very regrettably, the situation identified above and as described in The Boston Globe is not an isolated experience. There are frequent reports in the news regarding errors, as well as problems pertaining to controlled substances involving CVS stores. These situations are almost always settled and I have heard the CVS standard response so often that I can anticipate it before they say it – We acknowledge no wrongdoing. We are settling the matter to avoid the cost and inconvenience of further legal proceedings. The safety of our customers is our highest priority. In the situations in which I am aware of some of the specifics, the truth is that there was wrongdoing, and customer safety did not have priority.
In addition to the many allegations of the DEA and other regulatory agencies, numerous lawsuits are filed against CVS, as well as other large chain and mail-order pharmacies, because patients have been harmed or died as a consequence of alleged dispensing errors, preventable adverse events and drug interactions, negligence, or other mistakes. I am sometimes contacted by attorneys involved in such litigation who request that I serve as a consultant and/or expert witness. Although the total number of lawsuits about which I have been consulted is relatively small, a number of them have involved CVS. In some of these situations, it has been my opinion that there is not sufficient basis for a lawsuit and I decline to participate further. In some other situations, I have worked with the attorneys who are defending CVS and its pharmacists. In a few situations in which patients have died or experienced severe harm, I have worked with the attorneys for the plaintiffs or their families who are suing CVS. I much prefer to not participate as an expert for plaintiffs in actions against pharmacists/pharmacies. However, when 1) it is absolutely clear to me that an error has been made and/or there has been serious negligence, and 2) the defendant pharmacy denies any wrongdoing or claims that its pharmacists have no responsibility to do anything other than dispense a prescription exactly as the prescriber has written it, I have agreed to work with the plaintiff’s attorneys. The cases in which I have participated as a plaintiff’s expert against CVS have involved deaths or serious/disabling, irreversible adverse events. In most lawsuits filed against pharmacies, very few people ever hear about tragedies that have occurred because these cases rarely go to trial where the news media would become aware of and publicize the circumstances. Rather, these lawsuits are almost always settled out of court and the terms of the settlement are classified as confidential.
As just one of the individuals who is contacted, I am aware of the specifics of a relatively small number of the lawsuits against CVS. However, it is my understanding that, at any given time, there is a very large number of active lawsuits against CVS. That this observation is accurate is essentially confirmed by CVS’s refusal to identify the number and type of lawsuits it is defending. This information will remain secretive until some attorney identifies a strategy to obtain it, a whistleblower provides it, or a court or state board of pharmacy is sufficiently concerned to force CVS to reveal it.
What should CVS do?
I have the following recommendations for CVS:
Get rid of Caremark! In my opinion, it is a blatant conflict of interest for a corporation to own a pharmacy benefit manager/administrator (PBM) and a large chain of pharmacies, and the Federal Trade Commission should never have approved the acquisition of Caremark by CVS. Caremark’s inequitable and anticompetitive terms, policies, procedures, and audits are strongly and almost universally criticized by pharmacies other than CVS pharmacies. Concerns about direct and indirect remuneration (DIR) fees imposed by PBMs on pharmacies are the subject of a recent communication from the National Community Pharmacists Association (NCPA). For some pharmacies these fees can total thousands of dollars each month, and pharmacists responding to a survey identify CVS Caremark and Aetna as being the most egregious in this area.
For Caremark to be able to provide incentives to use its mail-order pharmacy to patients enrolled in the prescription plans it administers is anticompetitive. It is ironic that, in 2004, the CEO of CVS at that time stated, “We are opposed to forcing patients to use a mail order service and then dictating which mail order pharmacy to use.”
Walk your talk and actually give a high priority to patient safety! CVS’s hypocrisy with respect to its stated concern for patient safety is not acceptable. It is my understanding that the number of errors of commission and omission that occur in CVS pharmacies is astounding. Most of these errors are never known to anyone outside of CVS. However, as noted earlier, some have resulted in deaths and serious, irreversible harm.
Value your pharmacists! CVS is fortunate in that it employs thousands of highly capable pharmacists. However, a large number of these pharmacists feel they are important to management only because of the license they hold and not because they are skilled professionals who could provide comprehensive services for patients and make recommendations that would improve employee morale and contribute to the success of the company.
Many CVS pharmacists have strong concerns about their work schedules and what are often very long days in an understaffed and stressful environment in which they are expected to simultaneously manage lines of patients with prescriptions, telephone calls, the drive-through window, and requests for immunizations. The result is that pharmacists become disillusioned, demoralized, resentful, and burned out. They feel trapped by company policies and metrics. This situation is a recipe for errors, and errors occur. There are statistics but they are known only to CVS, and CVS will not reveal them. However, statistics and evidence of errors are not needed because sound judgment dictates that there is an increased risk of error in an understaffed and stressful workplace in which pharmacists have so little time to commit to each prescription and to speak with patients.
As noted earlier, when serious errors occur CVS will have enough money (sometimes in the millions) to reach a settlement. However, the pharmacist involved in the error can be at risk of having her/his license suspended or revoked.
How should CVS pharmacists respond? Many leave and find another position but this is increasingly difficult to do at a time in which the supply of pharmacists exceeds the number of positions available in many parts of the country. If employment conditions do not significantly improve, I anticipate that CVS pharmacists will form a national union or related organization that will include both the pharmacist store managers and staff pharmacists.
A pharmacist should personally speak with every patient with a prescription! The “sign here” charade must be abandoned.
Other pharmacies/pharmacists should be viewed as colleagues with mutual interests rather than competitors! CVS is intensively competitive, as are other large chains such as Walgreens and Rite Aid. In communities where these chains coexist, they are in very close proximity to each other, often just across the street or within the same block. I am aware of a situation in a mid-size community in Pennsylvania in which a CVS and Walgreens were essentially right next to each other and both were open 24 hours a day. However, no other CVS, Walgreens, or other pharmacy for miles around is open 24 hours a day. CVS and Walgreens give higher priority to competing with each other rather than serving the needs and interests of the community. In my community, CVS opened a pharmacy directly across the street from an independent pharmacy that had been in that location for decades.
Five recommendations are enough for now. I expect that the upper management of CVS will not agree with many or all of my observations. If that is the response, I offer to conduct a survey in which CVS pharmacists can respond anonymously to determine the extent to which they consider my comments to be valid.
CVS has an exceptional opportunity! At the present time it is not respected by many within the profession and by many even within its own company. However, it could regain the respect and positive reputation it enjoyed when the company started. At that time it promoted the professional role of the pharmacist and provided their pharmacists with the time to speak with patients and provide comprehensive professional services.
Some in the pharmacy community are pushing for Pharmacist to be considered a “practitioners” , which basically means that there is hopes of being able to charge pts and insurance companies for services/advice that has nothing to do with the dispensing of medication. This article adequately describes the paradox that today’s corporate employee has to deal with. When I was in school, the legal advice I was given that no matter what you did “in the pt’s best interest”.. as long as you did not charge for whatever you did… there was no “monetary motive” for your actions and you were in a very safe position. In today’s corporate environment, apparently any piece of inventory that is used without being paid for – regardless of the reason – it is considered THEFT. In this – or similar example – LOSS PREVENTION would come down on the Pharmacist and probably get fired for saving the pt’s life. IMO.. this ethical Dilemma is going to play itself out over and over in the coming year(s)… with now that bureaucrats are moving Narcan/Naloxone to a OTC status. The answer is… will Pharmacists be thrown under the bus ..by the corporation wanting to prevent NEGATIVE PR for not “giving away” Naloxone for someone in front of them dying of a overdose or will they be “fired” because the Pharmacist took care of a person in front of them dying from a OD without getting paid.
I remember staring out the window of my pharmacy school on a sunny day longer ago than I care to admit, suffering from a full-scale attack of senioritits. Graduation was just around the corner, and the professor was doing her best to keep the roomful of restless future pharmacists engaged in something productive. I was tuning in and out of the conversation until I heard the professor say something like the following.
“Say a person was walking past your pharmacy counter and suddenly started having serious chest pain. They’d never been in your store before, so they’d have no prescriptions on file with you. Would you give them a nitroglycerin tablet?”
I ignored what I thought a silly question (of course you would!) and went back to my daydreaming, until I realized to my amazement that a lively discussion was going on, with many soon-to-be professional pharmacists asserting that it would be the best decision not to offer relief to a person in serious distress.
When I took my first pharmacist job I asked my boss, who was then serving on the Ohio Board of Pharmacy, about this, and he chuckled.
“No matter what you do,” he assured me, “if you can frame it as ‘It was what was best for the patient,’ then you’ll be fine.”
Sound, commonsense advice for professionals who uses their judgment and expertise to make decisions, I thought.
Best, yes — but for whom?
Fast forward a couple decades, and as it turns out, that classroom discussion wasn’t so hypothetical after all. Consider this:
Katherine O’Connor was having an asthma attack while walking home in New Jersey with her boyfriend. Luckily, there was a drug store right there. But she only had $20, and the inhaler cost $21. And the pharmacist wouldn’t give it to her.
“I said, ‘Can you just give her the pump? She’s on the floor wheezing … I didn’t know if an ambulance would get there on time. He said there was nothing he could do for me.”
The above came from a story reported by New York’s Fox5 TV that made its way around the internet a few years ago.
By the time I saw it, I wasn’t nearly so surprised as I was in the classroom that day long ago. It was an extreme case, but after 20 years spent working for chain drugstores, I can understand how the corporate environment could intimidate someone into making the wrong decision.
Don’t get me wrong. I’m sure that if you were to ask any of the corporate bigwigs directly, they would tell you not to leave an asthmatic wheezing on the floor of their store. But those same bigwigs are also constantly sending out memos that say you must do this and we have zero tolerance for that, while the company’s liability lawyers have done everything they can to come up with a policy for every situation, which employees violate at their peril.
So when a snap decision is called for, “What is our corporate loss-prevention policy?” can compete in an employee’s brain with “What is the best thing for the patient?”
This means we have too many pharmacists who want all the credit for being professional without ever taking the responsibility for making a decision, such as ones who won’t dispense syringes to a patient with insulin in their medication profile, or who tell a tourist with no refills on a blood pressure medication that they’re just out of luck over the weekend.
We’ve all worked with one of “those” pharmacists, and from what I’ve seen, correcting “those” pharmacists doesn’t seem to be a priority among the big chains.
Am I wrong?
I might be wrong. Maybe there are now state board regulators who would discipline a pharmacist for giving nitroglycerin to a heart attack victim. If so, I’m dying to hear from one.
But not so literally as the patient who might be affected.
The war on drugs has made criminals of otherwise law-abiding citizens. Minority communities have been devastated, and our prisons are filled to a level never seen before.
Things are not going well. Falcon Heights, Minnesota. Baton Rouge, Louisiana. Dallas, Texas. All are locations of our most recent senseless deaths, leaving families and friends devastated beyond comprehension.
This national nightmare, when studied, always brings us back to the same conclusion. This country’s war on drugs bears direct responsibility for the militarization of the police, and it has caused a decades-long degradation of inner-city minority communities.
Just one glaring example of what the drug war has done to our judicial system involves the Fourth Amendment to the Bill of Rights, which states citizens are protected against unreasonable searches and seizures. This requires police under oath to convince an impartial judge an arrest or search should be made. Otherwise, evidence illegally obtained was inadmissible to prove guilt. This is called the exclusionary rule.
This radical restraint on the police is unique to all the other countries of the world. For 200 years it stood. Then came the drug war.
Keep in mind most illegal drug transactions are between consenting adults. Judges, out of some misguided sense of civic duty, began finding exception after exception for the exclusionary rule. The Fourth Amendment is now so shot full of holes that it more accurately resembles the flag that flew over Fort Sumter. Remember the words of Supreme Court Justice Louis Brandeis in this 1928 dissenting opinion from Olmstead v. United States: “The right to be left alone — the most comprehensive of rights and the right most valued by civilized man.”
All races of Americans use drugs at roughly the same rates, but the drug war is waged disproportionately against black and Latin-Americans. Tactics used in drug law enforcement in inner cities would not be tolerated for a single week in white suburbia. The drug war reduces police resources for investigating and prosecuting homicides. Homicide clearance rates in all major cities have fallen dramatically over the drug war years.
The war on drugs has made criminals of otherwise law-abiding citizens. Minority communities have been devastated, and our prisons are filled to a level never seen before. Millions of young persons have had their life chances dashed by the drug war.
The police are victims of the drug war, too. The police are duty-bound to enforce laws, no matter how foolish. Police frustration boils over into ever-increasing violent, invasive tactics. This has been going on for so long that the police’s role in our society has become almost irreversibly distorted.
If we want to have a peaceful, prosperous and just society, we must end prohibition. Narcotics control belongs in the public health arena, not in the criminal justice system.
Ever wonder why marijuana is scheduled by the U.S. Drug Enforcement Agency as “highly addictive and having no medicinal value?” It is because the Department of Health, Education and Welfare in 1970 determined that marijuana was similar to alcohol and should be similarly regulated.
When President Nixon learned of this, he transferred authority for scheduling drugs from the doctors and scientists at that department and to law enforcement at DEA. In spite of half of the states’ legalizing medical marijuana, the DEA clings stubbornly to keeping marijuana as a schedule I drug, i.e., having no medicinal value. A cynical person might suspect the DEA is really trying to stay in business.
Can we as a people pull ourselves together during these times? We cannot continue to wage a war on ourselves. The war on drugs must end.
This is the opinion of Robert E. Pottratz, an attorney from Melrose.
Conflicts of interest have become more the rule than the occasional exception. Even the trusted US Centers for Disease Control and Prevention (CDC) receives heavy funding from industry.
How this conflict of interest may have affected the organization’s decisions is the topic of an article1 in the British Medical Journal (BMJ), penned by the journal’s associate editor, Jeanne Lenzer, who notes:
“The Centers for Disease Control and Prevention (CDC) includes the following disclaimer with its recommendations:
“CDC, our planners, and our content experts wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products… CDC does not accept commercial support.”
The CDC’s image as an independent watchdog over the public health has given it enormous prestige, and its recommendations are occasionally enforced by law.
Despite the agency’s disclaimer, the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes, and the money it is taking.”
Is the CDC Protecting the Private Good Rather Than the Public?
When confronted about the discrepancy between the CDC’s public disclaimer and the reality that corporate funding is flowing into the organization, Tom Frieden, director of the CDC, responded, saying:
“Public-private partnerships allow CDC to do more, faster. The agency’s core values of accountability, respect, and integrity guide the way CDC spends the funds entrusted to it.
When possible conflicts of interests arise, we take a hard, close look to ensure that proper policies and guidelines are followed before accepting outside donations.”
In other words, the CDC believes, and “assures” you, it has the moral backbone to do the right thing, despite the fact that studies have revealed moral fiber tends to significantly deteriorate as soon as a funding source with an agenda starts doling out money.
Moreover, a 2009 investigation by the Office of the Inspector General concluded the CDC has “a systemic lack of oversight of the ethics program,” noting 97 percent of disclosure forms filed by the organization’s advisors were incomplete, and 13 percent of advisors didn’t file one.
Did Industry ‘Buy’ CDC Recommendation for Expanded Hepatitis C Screening?
External funding to the CDC in the form of industry “gifts” was authorized in 1983—nearly 40 years after the organization’s inception in 1946. After the passing of legislation in 1992 that encouraged relationships between the CDC and industry, the non-profit CDC Foundation was formed in 1995.
Last year, this Foundation received $12 million from private corporations, and the CDC itself received another $16 million in funding earmarked for special projects from companies, manufacturers, and various philanthropists.
“For example, in 2012, Genentech earmarked $600 000 in donations to the CDC Foundation for CDC’s efforts to promote expanded testing and treatment of viral hepatitis. Genentech and its parent company, Roche, manufacture test kits and treatments for hepatitis C,” Lenzer writes.
Since 2010, when the CDC and the CDC Foundation formed the Viral Hepatitis Action Coalition, manufacturers of hepatitis C tests and treatments have donated more than $26 million to the coalition.
In addition to Genentech, donors include: Abbott Laboratories, AbbVie, Gilead, Janssen, Merck, OraSure Technologies, Quest Diagnostics, and Siemens.
Two years later, in 2012, the CDC issued guidelines recommending expanded screening for hepatitis C for everyone born between 1945 and 1965, saying newer antiviral drugs can effectively halt disease progression.
However, “the science behind cohort screening has been challenged and is said to be ‘the subject of major debate.’ The scientific debate along with the price tags of the newer drugs (over $84 000 per treatment course for the new drug sofosbuvir), raise questions about CDC’s industry funding,” Lenzer writes.
CDC Recommendations Increasingly Skewed
The CDC and the CDC Foundation also received monies from Roche for the creation of the CDC’s “Take 3” flu campaign, again raising questions about the influence of funding on its drug recommendations.
Step 3 in the CDC’s flu campaign advises you to “take antiviral medicine if your doctor prescribes it.” In an article titled, “Why CDC Recommends Influenza Antiviral Drugs,” the agency cites a number of studies supporting its recommendation, including a recent meta-analysis published in The Lancet.2
The problem with that, Lenzer points out, is that the CDC describes this study as “independent,” when in fact it was sponsored by Roche. Moreover, all of the four authors have financial ties to Roche, Genentech (both of which sell Tamiflu), or Gilead (which holds the patent).
In addition to that, the CDC did not include last year’s systematic review3 of 83 trials conducted by the Cochrane Collaboration, which is the “gold standard” for independent research analysis.
Was this analysis ignored because it concluded Tamiflu alleviates symptoms of the flu by less than 17 hours, has limited effect on your risk of pneumonia, no effect on adult hospital admissions, and causes nausea, vomiting, headaches, renal problems and psychiatric syndromes?
According to the Cochrane group: “The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir [brand name Tamiflu] for treatment, prophylaxis, or stockpiling.”
Another issue is this: CDC director Tom Frieden has stated that taking Tamiflu might save your life, yet the US Food and Drug Administration (FDA) has warned Roche it cannot claim the drug reduces pneumonia or deaths as they’ve never produced any evidence for that claim.
But who needs scientific evidence when the CDC is making off-label claims for you? “Shannon Brownlee, senior vice president of the Lown Institute and former journalist covering the CDC, told
The BMJ, “This looks like classic stealth marketing, in which industry puts their message in the mouths of a trusted third party, such as an academic or a professional organization,” Lenzer writes.
FDA: The Poster Child for Industry Bias
The Food and Drug Administration (FDA) has also become notorious for its conflicts of interest and close ties to various industries, and there are many examples of this.
Last year, emails and letters between the FDA and Pfizer suggest the drug giant was given an inappropriate amount of leverage to decide when and how to tell the public about the hazards associated with its veterinary drug roxarsone.4,5
FDA researchers found low levels of inorganic arsenic in the livers of chicken who consumed the drug. Correspondence between Heidi Chen, then attorney in Pfizer’s animal health division, and William Flynn, the FDA’s deputy director for science policy at the Center for Veterinary Medicine, reveal the agency allowed Pfizer to edit the wording of a press release about the roxarsone data, and more.
Government Must Act to Protect Scientific Integrity
Getting back to the CDC, it was created and has been relied upon as an independent agency without industry ties that might muddy the water in terms of the health and safety recommendations it issues. Now, it’s become apparent that not even the CDC can be counted on for unbiased science-based advice. So what, if anything, can be done to rectify the situation?
Considering the fact that CDC funding from industry was approved by the government, the answer, as noted by Jerome R Hoffman,6 methodologist and emeritus professor of medicine at UCLA, is to “get the government to reject this devil’s bargain, by changing the rules so this can no longer happen.” It’s simply unreasonable to believe that any organization will ignore its cash cows, and it’s equally naïve to believe that industry will continue donating money if the agency decides to do anything that even hints at cutting into industry profits.
For example, the NRA promptly withdrew its CDC funding when the agency began investigating gun violence.7 In summary, conflicts of interest endanger lives. People’s well-being become secondary to the corporate bottom line, and no organization or corporation is immune to the effects of conflicts of interest—not even the CDC. Even well-respected research universities like the University of Minnesota have fallen prey, relaxing research ethics to the point that research subjects die.8
Head of CDC Now Head of Merck Vaccines
The infamous revolving door between the government and the drug industry is another factor that has done an awful lot to destroy scientific integrity and government accountability. One classic example is Dr. Julie Gerberding, who headed up the CDC—which among other things is charged with overseeing vaccines—from 2002 to 2009 before becoming the president of Merck’s vaccine division, a position she currently holds today.
The influence her former high-level ties to the CDC wields is enormous, considering the fact that Merck makes 14 of the 17 pediatric vaccines recommended by the CDC, and 9 of the 10 recommended for adults. And while vaccine safety advocates are trying to rein in the number of vaccines given to babies, safety concerns keep falling on deaf ears. The vaccine industry is booming, and it’s become quite clear that profit potential is the driving factor behind it. It is this type of reprehensible and inexcusable behavior that makes it an enormous challenge to change this seriously flawed paradigm.
Half of Published Research Likely to Be Completely False, Warns Editor-in-Chief of Major Medical Journal
Just as the CDC insists it has the ability to maintain its integrity awash in industry cash, corporations insist they have the integrity to stay on solid scientific ground when researching its own products. But, just as studies show the source of funding alters scientific conclusions, so research reveals that industry-funded research is riddled with flaws, shortcomings, and outright fraud. As reported by the Progressive Review:9,10
“… Dr. Richard Horton, the current editor-in-chief of the Lancet…recently published a statement11 declaring that a lot of published research is in fact unreliable at best, if not completely false. ‘The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness…’
Dr. Marcia Angell…makes her view of the subject quite plain: ‘It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine’” [Emphasis mine]
Omission of Data Often Protects Corporate Profits
Omission of data is another common tactic employed to skew the scientific consensus, and this is just as dangerous as publishing complete fabrications. For example, according to Dr. Lucija Tomljenovic,12,13 a post-doctoral fellow at the University of British Columbia (UBC) where she works in neurosciences and the Department of Medicine, many vaccine manufacturers and health authorities are actually well aware of dangers associated with vaccines, but have chosen to withhold this information from the public. She writes, in part:
“Deliberately concealing information from the parents for the sole purpose of getting them to comply with an ‘official’ vaccination schedule could thus be considered as a form of ethical violation or misconduct. Official documents obtained from the UK Department of Health (DH) and
the Joint Committee on Vaccination and Immunization (JCVI) reveal that the British health authorities have been engaging in such practice for the last 30 years, apparently for the sole purpose of protecting the national vaccination program.”
Many industry-funded studies with negative findings simply never see the light of day, as suggested by a recent NEJM review14 looking at compliance rates with results reporting at ClinicalTrials.gov. The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov, but only 13.4 percent of trials reported summary results within 12 months of completing the trial, and 45 percent of industry-funded trials were not required to report results. For comparison, only six percent of trials funded by the National Institutes of Health (NIH) and nine percent of studies funded by other government or academic institutions were excluded from result reporting.
Doctors Also Share the Blame…
Bias is another major problem that has increasingly sullied the scientific community, and no one is immune—not even doctors, especially not when they’re receiving large sums of money from a drug company. According to “the most comprehensive accounting so far of the financial ties that some critics say have compromised medical care,” published last year, American doctors and teaching hospitals received a whopping $3.5 billion from drug and medical-device companies in the last five months of 2013 alone.15
A recent article16 in NEJM titled “Understanding Bias — The Case for Careful Study,” offers a discourse on bias, at the core of which you find financial conflicts of interest. But there are also a number of other hidden, largely subconscious conflicts within any given individual that can color his or her decision-making, such as how easy one treatment is versus another—one might require hours of work, while the other would allow the doctor some well-needed sleep.
Either way, conflicts of interest do have an impact on the patient, and when the motive is selfish—be it to gain more money or sleep—that impact is likely to be detrimental. As noted in the NEJM article:
“Some 94 percent of physicians have relationships with industry, though these interactions most often involve activities such as receiving drug samples or food in the workplace… Physicians who attend symposia funded by pharmaceutical companies subsequently prescribe the featured drugs at a higher rate… Are any of these interactions, or efforts to curtail them, beneficial or harmful to patients? It depends on how you define harm. Consider pharmaceutical ‘gifting,’ a practice that smacks of bribery — which may be sufficient reason to prohibit it. But does it actually hurt patients? According to one influential commentary, it does…”
Doctors Urged to Stop Overtreating Patients
Yet another BMJ article17 urges doctors to stop overmedicating and overtreating patients, warning they’re doing more harm than good. As reported by BBC News18:
“Launching the Choosing Wisely campaign, experts are calling on medical organizations to identify five procedures each that should not be offered routinely or in some cases not at all. These might include: Pills for mild depression; Too many routine and unnecessary blood tests; Medicines for mildly raised blood pressure… [E]xperts say individuals should be encouraged to check whether procedures are definitely right for them. For example, patients are advised to ask: Do I really need this test or procedure?; Are there simpler options?; What happens if I do nothing?”
Overmedicating and overtreating is one result of excessive industry influence, although it’s certainly not the sole reason. From my perspective, it seems clear that more drugs, tests, and surgeries do not equate to better health. On the contrary, it raises the risks of side effects that may be as bad or worse than the original problem. It also raises the risk of fatal medical errors—a fate that befalls 440,000 Americans each year! As reported by Forbes19 in 2013:
“These people are not dying from the illnesses that caused them to seek hospital care in the first place. They are dying from mishaps that hospitals could have prevented. What do these errors look like? The sponge left inside the surgical patient, prompting weeks of mysterious, agonizing abdominal pain before the infection overcomes bodily functions. The medication injected into a baby’s IV at a dose calculated for a 200 pound man. The excruciating infection from contaminated equipment used at the bedside. Sadly, over a thousand people a day are dying from these kinds of mistakes.”
Drug Ads May Lose Fine Print Details About Side Effects
Have you ever asked your doctor if a certain drug was right for you—as instructed by virtually every drug ad you see on TV? Clearly, this ploy works, or the drug industry wouldn’t spend $4.53 billion a year on direct-to-consumer (DTC) advertising.20 In the midst of all the faux science backing up recommendations to use drugs of all kinds, the Food and Drug Administration (FDA) is considering simplifying DTC print ads by making the manufacturers summarize potential side effects in layman’s terms—and omitting certain drug details altogether. Cutting the laundry list of side effects from radio and TV ads is also under consideration, ostensibly to improve your understanding of the drug’s risks.
“‘In general, FDA believes that exhaustive lists that include even minor risks detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks,’ the FDA says in its draft guidance on the proposed changes to print ads.The agency cites research showing that people can only process a limited amount of information offered in DTC drug ads. Furthermore, the FDA found, virtually no one reads even half of the fine print in drug ads, and of those who do, 55 percent say it’s hard to understand. The agency also cites several studies showing that when drug risks are described in laymen’s terms instead of medical jargon comprehension skyrockets.”
It’s difficult to discern whether a change like this might actually change how consumers “hear” or “see” the benefit versus risk potential of any given drug. In my view, the most reasonable approach would be to dramatically reduce or ban DTC drug ads altogether, as they do absolutely nothing to improve public health. On the contrary, luring people into thinking they might benefit from a drug is a recipe for disaster, as it reinforces the fallacy that there’s a magic pill for every ill, when in fact most ailments can be effectively prevented or addressed with inexpensive lifestyle changes that have no detrimental side effects whatsoever.
History is replete with examples of drugs causing far more harm than good. Vioxx is one classic example. It killed about 60,000 people before being withdrawn from the market. Most recently, Takeda Pharmaceutical has agreed to pay $2.4 billion to settle some 9,000 lawsuits from patients who developed bladder cancer from the drug22–a side effect the company concealed, according to plaintiff attorneys. Despite such risks, Actos is still sold in the US and other countries.
Hopefully, you will resolve to take control of your health and avoid becoming a statistic of a conflict-of-interest-driven system that places greater value on share holders than patients. Addressing your diet is an obvious place to start, along with a regular exercise program.
If your boss gave you an TASK/JOB to accomplish… would you come back and generate a report that clearly demonstrates that you were failing miserably… do you think that you would keep your job if you just produced a warning video telling everyone that you were failing your appointed task/job and putting many in the public at risk. Do you think that you should keep your job or should you be given more money and staff to continue doing what you have been doing – badly – for the last 46 years ?
Hundreds of thousands of counterfeit prescription pills, many containing deadly amounts of fentanyl and fentanyl-related compounds, have made their way into the U.S. drug market, according to a DEA intelligence report released today. Law enforcement nationwide report higher fentanyl availability, seizures, and known overdose deaths than at any other time since the drug’s creation in 1959.
Fentanyl is a synthetically produced opioid that, when produced and administered legitimately, is used to treat severe pain. Overseas labs in China are mass-producing fentanyl and fentanyl-related compounds and marketing them to drug trafficking groups in Mexico, Canada and the United States.
In addition to being deadly to users, fentanyl poses a grave threat to law enforcement officials and first responders, as a lethal dose of fentanyl can be accidentally inhaled or absorbed through the skin.
DEA recently released the Police Roll Call video below, nationwide to warn law enforcement about this danger.
(‘FENTANYL – A Real Threat to Law Enforcement’, courtesy of the DEA)
Fentanyl and fentanyl-related compounds are traditionally mixed into or sold as heroin, or on its own, oftentimes without the customer’s knowledge. Since 2014, U.S. law enforcement agencies have been seizing a new form of fentanyl—counterfeit prescription opioid pills containing fentanyl or fentanyl-related compounds. The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyl is only detected upon laboratory analysis.
Fentanyl traffickers have been successful at expanding the fentanyl market and introducing new fentanyl-laced drug products to the U.S. drug market. The DEA National Forensic Laboratory Information System (NFLIS) reported that there were 13,002 fentanyl exhibits tested by forensic laboratories across the country in 2015 (the latest year for which data is available), which is a 65 percent increase from the 7,864 fentanyl exhibits in 2014. There were approximately eight times as many fentanyl exhibits in 2015 as there were during the 2006 fentanyl crisis, clearly demonstrating the unprecedented threat and expansion of the fentanyl market.
The rise of counterfeit pills that contain fentanyl in the illicit drug market will likely result in more opioid-dependent individuals, overdoses, and deaths. There were over 700 fentanyl-related deaths reported in the United States between late 2013 and 2014. During 2013-2014, the Centers for Disease Control (CDC) reported that deaths from synthetic opioids increased 79 percent, from 3,097 to 5,544. Although the synthetic opioid category does contain other opioids, this sharp increase coincides with a sharp increase in fentanyl availability, and the CDC reports that a substantial portion of the increase appears to be related to illicit fentanyl.
In March 2016, law enforcement officers in Lorain County, Ohio, seized 500 pills that visually appeared to be oxycodone. The pills were blue and had “A 215” markings, consistent with 30 milligram oxycodone pills. Laboratory analysis indicated that the pills did not contain oxycodone, but were instead the research chemical U-47700. U-47700 is an unscheduled synthetic opioid not studied for human use that has caused at least 17 overdoses and several deaths in the United States.
Many Chinese laboratories illicitly manufacturing synthetic drugs, such as fentanyl and their precursors, also manufacture legitimate chemicals for purchase by U.S. companies. This means that laboratories responsible for supplying fentanyl in counterfeit pills can also run legitimate businesses. Although Chinese clandestine laboratories may be contributing to the fentanyl supply, legitimate laboratories may also be sources of supply.
Traffickers can typically purchase a kilogram of fentanyl powder for a few thousand dollars from a Chinese supplier, transform it into hundreds of thousands of pills, and sell the counterfeit pills for millions of dollars in profit. If a particular batch has 1.5 milligrams of fentanyl per pill, approximately 666,666 counterfeit pills can be manufactured from 1 kilogram of pure fentanyl.
To access the full report “Counterfeit Prescription Pills Containing Fentanyls: A Global Threat”, click here.
