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PDF Editor FAQ
Would you rather be an alcoholic or a stoner?
This answer may contain sensitive images. Click on an image to unblur it.If by “stoner” you mean pot-smoker, there is no question.While pot-smoking may have risks, they are no where near the level of harm that alcoholics face.An estimated 88,000 people (approximately 62,000 men and 26,000 women) die from alcohol-related causes annually, making alcohol the third leading preventable cause of death in the United States. The first is tobacco, and the second is poor diet and physical inactivity.[1]As opposed to:Deaths from Marijuana vs. 17 FDA-Approved DrugsNote that the marijuana statistics came with the following caveat: “Numbers from these data must be carefully interpreted as reported rates and not occurrence rates. True incidence rates cannot be determined from this database. Comparisons of drugs cannot be made from these data.”Unfortunately I’m unable to smoke cannabis: With every inhale comes a severe cough lasting 2 to 3 minutes (and I mean severe to the level where I gag and almost throw up.)Footnotes[1] Alcohol Facts and Statistics
Do you think employers should stop testing for marijuana for pre-employment and random drug screening?
This is a question that we get asked more and more often these days — whether a company should consider eliminating the testing requirement for marijuana due to the fast-changing state-specific rules. A response to this question requires an understanding that there are many different rules applicable to drug and alcohol testing both, state-by-state, and applicable federal rules. The most appropriate answer would also require us to know more about what the root concerns are for a company to consider removing marijuana from their testing panel(s), and what are the company’s overall hopes and goals for their workplace screening program. In general, we advocate that employers should continue enforcing drug-free workplace programs, including the screening for marijuana use unless there is a specific reason, issue or concern that an employer can justify otherwise.In lieu of a direct engagement opportunity, we offer a breakdown of the question and related facts, to help you determine what the best course of action is for your workplace.Marijuana @ WorkCurrently, there are 10 states that have authorized the legal use of marijuana for anyone 21 years old or older (CA is "over 21-yrs old"): Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont & Washington (and Washington D.C.). Although criminal & civil penalties saw a dramatic change, it’s very important to note that each of these state's laws specifically provides that Employers do not need to accommodate employee marijuana use at work.Employers are still authorized to prohibit the use of marijuana, permitted to test for marijuana use and authorized to discipline employees that violate workplace screening programs.As of this November, 33 states (Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Utah, Vermont, Washington, West Virginia (and Washington D.C.) now permit the medical use of marijuana.17 states have adopted some form of law permitting the use of Cannabidiol (CBD) (a non-psychoactive component found in hemp and marijuana plants) for patients that meet requirements from very specific lists of medical conditions. In June of this year, the Food and Drug Administration (FDA) approved the first ever cannabis-derived drug (Epidiolex) for the treatment of specific epileptic conditions. The DEA has authorized this drug as a Schedule V substance. In general, CBD products are now being sold nationwide in various forms (concentrates, oils, edibles, balms, rubs, drinks, etc.) and concentrations, with little regulatory oversite.Drug Use on the RiseDrug use in America is at its highest levels in more than a decade. According to the latest data from the National Survey on Drug Use and Health (NSDUH), an estimated 30 million people, or 11.2% of the U.S. population, used an illicit drug in the past month. One in seven people, or 20.7 million Americans, needed substance use treatment in 2017. Approximately 26 million people were current marijuana users.Overall, according to the recent Quest Diagnostics Drug Testing Index, marijuana positivity continued its five-year upward trajectory in urine testing for both the general U.S. workforce and the federally-mandated, safety-sensitive workforce. Marijuana positivity increased four percent in the general U.S. workforce (2.5% in 2016 versus 2.6% in 2017) and nearly eight percent in the safety-sensitive workforce (0.78% versus 0.84%).Increases in positivity rates for marijuana in the general U.S. workforce were most striking in states that have enacted recreational use statues since 2016. Those states include Nevada (43%), Massachusetts (14%) and California (11%).Three states also saw significant increases in marijuana positivity in federally-mandated, safety-sensitive workers: Nevada (39%), California (20%), and Massachusetts (11%). Federally-mandated, safety-sensitive workers include pilots, rail, bus and truck drivers, and workers in nuclear power plants, for whom routine drug testing is required by the DOT. You can view the Quest Diagnostics interactive map for more details on how marijuana use in your state compares to the rest of the nation.The LawsNo state, that has authorized either the personal use or medical use of marijuana, prohibits an employer from including marijuana in a work-related drug testing program. Moreover, with limited exception (Connecticut, Massachusetts, and Rhode Island) in court decisions, where an employee who is also a legal marijuana user challenges an employer's discipline following a positive test result for marijuana; the employer has won.With limited exception, (e.g. AZ, DE, MN, NY & potentially MI) states with medical marijuana laws do not require employers to accommodate an employee’s medical marijuana use.Employers can continue to enforce drug-free workplaces, including the screening of marijuana. Employers are still permitted to prohibit the use, possession, sales, etc. while at work, in a company vehicle, or on company property.Employers are not limited from refusing to hire, discharging, disciplining, or otherwise taking an adverse employment action against an employee that violates their drug-free workplace policy or because they were at work while under the influence of marijuana.Who and When to Test?Except as noted below, there are no mandatory state-specific laws that require an employer to test for marijuana use. There are certain states that limit what employers can screen for (e.g. Oklahoma – screening is limited to Schedule I, II, or III drugs only; other state exceptions) and there are federal limits (such as the Americans with Disabilities Act and the screening of prescription drugs) and state disability discrimination rules that must be considered, but in general non-regulated employers have never been ‘required’ to screen for marijuana use.We could write an entire separate article on the benefits of including marijuana in workplace screening programs. It has been an industry best practice for more than 30 years. Past studies have shown the impacts of marijuana use in the workplace to be very costly specifically related to:AbsenteeismLost productivityChanges in mood & emotionsPoor judgment & coordinationShort-term memory problemsImpaired thinkingLoss of balance and coordinationDecreased concentrationChanges in sensory perceptionImpaired ability to perform complex tasksDecreased alertnessDecreased reaction timePre-Hire vs Post-Hire ScreeningIt is very common for a company to require a drug test as a post-offer condition of employment. This test commonly includes the screening for marijuana use.A popular headline in the news as of late is the number of employers struggling to find workers that can pass a drug screen. Related to that is the general perceived “unfairness” with the dramatic difference in the detection time period for marijuana use. Marijuana and its metabolites are fat-soluble and store in the body longer the other popular drugs of abuse. With the lack of a true method to show that someone is “under the influence” of marijuana, it is nearly impossible to make a distinction between someone being “high” right now or if it was off-duty use (use over a weekend, habitual use, etc.).It is important to note that, just because a prospective employee fails a drug screen for marijuana doesn’t mean the employer must take adverse action or deny employment. (There is a serious question whether this can be done at all in Maine) Employers still have the option to hire the employee, evaluate the nature of the job to be performed and decide whether there is a safety or security concern or if reasonable accommodations would be appropriate or not.A company’s drug-free workplace program also commonly includes the requirements of testing apart of a random screening program or in reasonable suspicion and post-accident situations. The continued testing for marijuana in these situations is likely crucial.So, as an alternate solution to a blanket removal of marijuana testing, a company may choose to assess the value of their pre-hire screening panel compared to that of their post-employment screening panel.By Employee Group or Job FunctionAs another alternative, an employer can make distinctions between employee groups and how or when the company drug testing is imposed.Distinctions between workgroups happen in drug testing all the time. Some companies choose to apply random testing to safety-sensitive workers only (required in some states like Minnesota). Some states limit employers, for example, post-accident testing is not allowed in 5 states and 2 cities; employers in many states (and Boulder, CO) can't conduct observed collections of a sample. In Iowa, the law allows employers to randomly test all workers or just some workers at a site. 31 states have laws that require employers to drug test some workers, but not others. As we’ve mentioned, it is very important to understand the rules that apply to your specific workplace screening program.When is Marijuana Testing Required?Department of Transportation (DOT) Testing: Companies that have employees conducting federally regulated work (truck drivers, bus drivers, pilots, boat captains, rail workers, etc.) MUST follow DOT drug & alcohol testing rules which include the screening of marijuana. Furthermore, the DOT has made it very clear that medical marijuana users are not exempt from federal DOT regulations.State Benefits Programs: There are 15 states that offer benefits to employers who voluntarily comply with state workers’ compensation premium discount programs (Drug-Free Workplace Programs). To earn the benefits the employer must comply with a very complex set of rules including when to test, how to test and for what substances - which includes the required screening of marijuana.Federal Grants: Companies that operate from a state or federal grant likely must continue to screen for marijuana as a condition of the grant.Contractor/Subcontractor Work: It is very common for contractors and subcontractors to require the screening of marijuana, whether by company policy, contract requirement, customer requirement, etc.State Regulations: Several states have some form of law or rule that specifically requires employers to follow Federal (HHS/DOT) rules, which includes screening for marijuana, either in general and in specific circumstances.There are 12 states that prohibit discrimination of an applicant or employee simply because of their status as a medical marijuana patient. (or in the case of Maine, personal use – “off property.”). As one example, the state of New York’s Compassionate Care Act (CCA) created new anti-discrimination protections for medical marijuana users. The CCA namely provides that patients who are certified for medical marijuana use shall not be subject to “disciplinary action by a business” for exercising their rights to use medical marijuana. The CCA further provides that being a certified patient is the equivalent of having a disability for purposes of the New York State Human Rights Law.Suggested Action Steps for Employers· Clearly understand the state-specific drug & alcohol screening laws and court & agency rulings that apply to your company in each state(s) you operate in.· Evaluate the pros and cons of the screening of marijuana for your specific workforce.· Create and/or update and implement a written Drug-Free Workplace Policy that clearly states the company’s stance on prohibited drug & alcohol use and the related consequences that will be imposed. This policy should be reviewed at twice a year, if not more often.· Design and implement sound processes and procedures that complement the language within the company policy. This will remove any guessing or potential mistakes when action needs to be taken in the 'heat of the moment'.· Educated your employees on the dangers and impacts of drug and alcohol use.· Encourage employees to seek help with any drug or alcohol dependency or addiction through your Employee Assistance Program (EAP) benefits.· Train your managers and supervisors on the details of your companies Drug-Free Workplace policy. Help them understand the laws that apply (including the Americans With Disabilities Act (ADA)). Train them on how to recognize the signs of impairment from drug or alcohol use and clearly define the action steps they should take in these instances.· Stay up-to-date with the rules, regulations and court decisions that may impact your program.Resource: Drug Screening Compliance InstituteDisclaimer: I am not a lawyer. The information contained herein is for general informational purposes only.
What are the major problems with the pharmaceutical industry?
This is a broad question, and giving broad glib answers serves no purpose.We must also acknowledge there exists various degrees of relevance and urgency with regard to their own well being, or level of greed, from Pharm to Pharm.But just how BIG is 'Big Pharma? If Big Pharma's annual global market was compared to the GDP—the market value of allthe output produced in a nation in one year—then they would rank number 15 on a list of 183 nations. That's how BIG the pharmaceutical industry is!I will address what I see as 'important' to their employee's, and perhaps what is important to their customers; and I'll need define the 'Pharmaceutical Machine' as I'm considering it.You will see there are a number of issues that come together to confound the future success of the Pharmaceutical industry, and since their goal is to turn a 'healthful direction'into a profit, their definitions of this potentially touches everyone.Global View:A first distinction is a drugs' potential to extend life whilenot necessarily improving the quality of it. [Only three states in the U.S. tolerate assisted suicide, and from a big Pharm perspective, such an attitude cuts into profits.] Pharmaceutical's pay only lip service to this distinction. There were 5 million Alzheimer's patients last year in the U.S. alone; for all of them, their 'self identity' is, or has already dissolved away. For one third of them, they would be better treated by any veterinarian, as their expensive ongoing maintenance is no joy to them or anyone else. Typically, these patients will eventually be removed from a feeding tube, and they will slowly die from starvationwhile sedated. That's the American Way- not a pretty picture is it? The local veterinarian can treat your pet far kinder than you can treat your own parents. Not only do Pharmaceutical firms shy away from assisted suicide, they also refuse to make lethal injection drugs for those on death row; no profit in it.As Marijuana has become legal, you can expect Pharmaceutical's to chase some profit; expect synthetic liquid THC to be available for under the tongue application. Switching from vodka martini's to pot couldn't become more simple.Very expensiveanti-cancer drugs are in the pipeline, each a $100k+ patient commitment, whether they work or not. These are personally tailored cancer 'magic-bullets.' We can expect a massive battle by insurance companies to dismiss or impune their efficacy, as that may be the cheaper path.Similar to targeted (MRI) tests that label Alzhimer's proteins (since 2010), insurance companies have been able to avoid covering such testing.Coverage Denial For Amyloid Scans Riles Alzheimer’s Community. The ability of insurance companies to dodge expensive treatments, and the increasing cost of medicines will no doubt exacerbate the worlds' perception that only the ritchcan dodge cancer, while the poor (under $250k/year) will die. Certainly the methodology for these cancer treatments will fall in price, but even at a $20k gamble, the distance between the 'have' and 'have nots' may become chilly.Lastly on this topic, determining heart health, and treatment remains DOMINATED by STENT MANUFACTURES, while Stents remain a trap, and ill-advised when looked at in contrast to other non-invasive treatments, and, when necessary: by pass surgery. Note that the appication of Stents BLOCKS effective bypass surgery for the patients so impacted. DOING Calcium CAT scans is the method of choice for determing heart health, NOT the use of misleading EEG's etc. The State of Texas identified this, and made Ca CAT scans to be OBLIGATORILY covered by insurance companies... follow the money fighting this to the Stent manufacturers.Employee ViewA medium sized Pharmaceutical firm has two large groups: the manufacturing arm, and the Research group. Sub groups between them include the QA/QC to oversee the obvious, and an Engineering group, whose task includes maintaining the manufacturing, and being capable of ramping up new manufacturing hardware when dictated by better techniques, or most often: the launch of new products (by the Research group).If little is being shipped out the door, no money comes in, so therefore during hard times it is the R&D group that should be getting their resumes out there, they are a luxury item.The Research groups within a company are highly diverse, with perhaps unique specialties, from 'small molecule', bacteriology, and the shot-gun application of 'designer' molecules with mathematically favored (derived) outcomes, and new trends in identifying genetic tumor markers so that targeted drugs can be specified (-the cost of these treatments are predicted to run $10k per week).There is no reason to have R&D physically close to Manufacturing; although that has been the case up until the 90's for most companies. Expect more manufacturing to transfer off-shore. Singapore and India have been doing very well in this regard.For Engineering QA (calibration & maintenance), subcontracting out entire former in-house functions has become the trend in the past 15 years, as the mistreatment of these groups can be more easily handled via third parties; -publicly sour 'genuine' employees are to be avoided. Much of the success of these companies is the perceivedvalue by their stock holders, so maintaining a 'great employer' facade is crucial to their stock market value.When Roche moved 80% of their Genentec manufacturing to Singapore, great and costly care was employed to 'retire' long tenured manufacturing and maintenance staff.Maintaining an illusion of 'products in the pipeline' is also key to their stock value, and many older companies are putting forward the 'repackaging' of their old products as being valid 'pipeline' members, when they may be pretenders at best. When stock market watchers view a company with two items in the Pipeline, vs. a company with five, they may fail to notice that 4/5's of the latter declarations are a rehash.The 'swallowing up' of smaller Biotech companies is mostly encouraged by the need to dispense with 'profits' (by the purchasing company) before the Federal tax-man cometh; and such acquisitions are typically seen as advantageous by the stock holders (whether they really are a value or not). This problem of disposable cash, 'use it or lose it' can also go towards pressing for short-sighted future planning; it mandates the need for a competitive company, particularly one that will soon be facing generics of it's own products, to be based outside the U.S.It is not that Novartis and Roche seek cheaper labor overseas, they simply seek better tax incentives, as well as a predictable andgrateful workforce (read: non-union environment, no pension). In the San Francisco Bay Area, only Bayer was Union, Chiron-Novartis and Genentech-Roche needed happy employees both for the stockholder picture, and also to keep the Bayer Union (AFL-CIO) away. And for a better 'corporate' picture (current ratio), I've seen perfectly good inventory destroyed rather than present a poor inventory/income ratio to the stock holders when the quarter is heading south.The first key problem is that if there can be no patent, then there can be no profit in it, and there is no incentive to research it; or even support a positive 'spin' for a drugs application, -or the 'natural' herb from whence it came; even though a positive public health issue is addressable. Better yet, ifa 'negative spin' can be publicized, then perhaps a shift to a profitable patented medication may be forthcoming.Doctors pretty much finish their education when they leave Medical School; what ever they swallowed then is where their thinking tends to remain; other than the advertisements in the Lancet, they are kept way too busy to keep up with the R&D in their specialty. In fact, their easy deference to 'specialists' is simply the hope that the 'specialist' may keep-up a little better than they do; specialists are frequently a CYA action. Doctors take all the publicity they receive from Pharmaceutical vendors and ads as gospel.The R&D groups among all of these companies remain mute although their theoretical grasp of leading edge directions (and misdirections) far exceeds that of the Universities IMHO. Many teams are allowed to pursue dead-end pursuits simply because of their grasping of profitable correct paths in the past; these teams are at the 'top' of the Pharm companies' luxury expenditures list- and will be the first dumped into a small parachute when crunch-time comes.From caffeine to ibuprofen, since any low-profitability company can manufacture it, to spend one cent towards assembling contrasting data of it's use, for either implied applications, or it's ongoing efficacy against very expensive prescription drugs. For example, Ibuprofen has been the 'go to' anti-inflammatory for decades, and there is implied indications that it has the ability to 'shift' the onset of Alzheimer's to a later date; it can't 'cure' Alzheimer's, but for those that have taken it for chronic back pain at ages older than 35, they may have also shifted their frank dementia issues to a later date. The possibility of Ibuprofen to have been doing this for the past 30 years would seem to be of keen interest, but it can't be, there is NO MONEY IN IT. There is profit in developing patentable equivalents to ibuprofen, and to demonstrate any 'positive s's only subtracts sales for those drugs, and enhances sales for other (cheaper) manufacturers. However, the longtime-line for demonstrating anti-Alzheimer's properties is beyond practical interest.If the FDA isn't on the 'take' from 'Big Pharm' they sure ought to be. Take for example some expensive popular antidepressant medications, an April 2002 study in the Journal of American Medical Association compared the effectiveness of Zoloft, St John’s Wort, and a placebo and found that the placebo treated patients had the highest rate of remission of symptoms at 31.9%, and Zoloft’s 24.8% was barely better than the rate of remission with St John’s Wort of 23.9%.The FDA’s own records on Celexa (citalopram) show the agency knew the drug to be ineffective when it was approved, and the agency based its approval on 2 marginally positive studies out of a total of 17 conducted.Also, let's look at Pfizer's Celebrex, an expensiveanti-inflammatory that was pressed upon the medical community as being, unlike Ibuprofin, 'gentle to the stomach;' In fact, it was not. The research was cherry-picked to support that conclusion, they released short term positive data, and witheld very negativelongterm data. It was as harsh as Ibuprofin on the stomach, yet was not as effective, but Pfizer's marketing moved full steam ahead with their deceptive marketing blitz against other, generic anti-inflammatories. Their income was $51.6 billion. They were hit with large punitive damages a few years later by the FDA, but these fines are tax-deductibleso the FDA has the option of raising the award to offset the tax windfall.80% of the Doctor's today remain proscribing Celebrex to their insured customers, because the false advertising was never retracted, and not given a blerb by the FDA on the inside page of the Lancet. Pfizer Stock continues to climb in value.LYING about the efficacy of 'new' drugs in contrast to older remains the norm for many companies, not just the king of it all: Pfizer (Pfizer: Corporate Rap Sheet), which demonstrated practices of bribery, pushing off-label usage, taking advantage of 3rd world venues for 'testing' as well as lies about efficacy. To balance this warped corporation among the industry is Hoffman LaRoche, which is responsible for historically allowing, without license, the use of their developed 'sandwich technique' used by perhaps a thousand diagnostic start-ups over the past 40 years. The use of the lawyers to 'sink' start-ups is very much an ongoing practice, whether the legal case has any merit at all doesn't matter- the court-games over a three year period on a 'complex' chemical process can milk small companies dry... as their 'angel' funding goes dry, and their employees abandon ship. I've seen High School labs better equipped then some small start-ups, as they scrape to get projects done without proper equipment, and their nest egg goes to lawyers.The FDA sets out guidelines, and inspects manufacturing sites to insure a direction towards guideline adherence. There are MANY ways to adhere to a 'guideline,' some are much more efficacious (read: functional and cheap) than others. Does the FDA help, or indicate that some Pharmaceutical companies are 'over the top' in their pursuit of a guideline? NO! They remain mute, and do not guide companies down a better path. Changing from an old expensive 'approved' habit is VERY expensive, and not at all supported by the FDA, even if they are well aware that a less arduous solution is better.Generics coming from foreign third-party manufacturer's must demonstrate the active ingredient; they ALSO must demonstrate that 'other stuff', in contrast to the 'original patented' concoction is not present. It doesn't MATTER if the 'other stuff' is inert, or harmless.This makes it advantageous for the original maker to proprietarily (read: secret method) filter out (or add) 'something', so that approximating their actual concoction is... difficult. [What isthat 'unknown' peak? Is it significant? The FDA comes down on the assumption it's VERY BAD, and facilitates little aid in proving otherwise to third party manufacturers. Never mind it's been in use for 10 years in areas other than the U.S. without harm]I recall city mayor's in the S.F. Bay Area touting that theywere 'on their way' in increasing Big Pharm in their cities, when at the very same time, ALL these companies were in the process of moving their manufacturing over-seas. [Genentech/Roche; Chiron/Novartis, and later, actually pushed out of Berkeley: Bayer). This could be more concerning if Big Pharm was unique, but ALL U.S. companies behave similarly. Motorola (now sold off) did it's best design and manufacturing in India; Intel too does much of it's R&D in India, and postures how they need import MORE employee's from overseas ( from India) at the SAME TIME as they lay-off existing American workers. (Intel layoffs detailed - 165 in Santa Clara) Microsoft is doing the same thing.Corporate 'America' is NOT American!There are now NO U.S. owned companiesthat make vaccines for example. This became 'secret' when we found that a French company wasn't going to ship all that it could to the U.S. during a flu-scare 5 years ago. For all 'big businesses': business is business.
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