"Pink Viagra"

"Where are the crowds of women with low libido clamouring for Addyi?"
"They never existed, except in a public relations firm's fantasy."
PharmedOut, Georgetown University Medical Center, Washington

"The FDA is being responsible ... yes."
"[However], some people are now arguing REMS [risk evaluation and mitigation strategy] was a scare tactic the FDA imposed because it didn't particularly like being dragged back into this whole debate about whether HSDD [hypoactive sexual desire disorder] is truly an unmet medical need."
"[Female sexuality is] a much more sophisticated process [than what Viagra overturns by increasing blood flow to the penis]."
Dr. Jim Pfaus, professor of psychology, Concordia University, Montreal

The Food and Drug Administration on Tuesday, Aug. 18, 2015, approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the ockbuster success of impotence drugs for men. AP Photo/Allen G. Breed

Professor Pfaus has a personal interest in the debate, having led some of the earliest studies to determine effects of flibanserin [Addyi] on female rats' sexual desire and resulting copulation. And while he conducted research for the Canadian Institutes of Health Research, he also was in receipt of consulting grants from Addyi's original formulator, Boehringer Ingelheim, before it was bought out by Valeant Pharmaceuticals International, headquartered in Quebec.

There are those who claim that governmental drug regulators have set up barriers for access to this 'pink Viagra', restricting access by requiring doctors and pharmacies to obtain certification to prescribe or dispense the pills. Instructions that accompany the drug include the warning that women using it must never drink alcohol while using the drug, which has the capacity to cause low blood pressure and syncope, a sudden loss of consciousness.

When Sprout Pharmaceuticals obtained FDA approval for the Addyi it was producing, realizing success on the third try after the drug had seen rejections over safety concerns, Valeant bought the copyrighted formula along with the company itself for $1-billion. That gamble rested on the assumption that Addyi would turn out to be as successful on the consumer market as its male predecessor has been.

However, there is a world of difference between the two drugs' interaction with the human body; Viagra's effect was mechanical, while Addyi's is psychological, in essence sending its message to the brain. Addyi must be taken daily, unlike Viagra whose calculated use is just before sex, to increase blood flow to the penis. Unlike Viagra which sold over a half million prescriptions in its first month on the market in 1998, a mere 23,000 prescriptions were dispensed for flibanserin in the U.S. since 2015.

When it was approved in August 2015 by the U.S. Food and Drug Administration, it was said to be with the proviso that advertising on television or radio not take place for the first year-and-a-half of its commercial availability. In Canada the drug remains in uncompleted review status by Health Canada, though it had been submitted over a year ago for approval. Critics of the drug feel its lackadaisical uptake reflects women's unwillingness to use Addyi.

It comes at quite the cost; $800 (U.S. monthly), and nor is its effect particularly assured. It is recognized as a risky drug which produces an average single extra "sexually satisfying event" per month more than would a placebo replacement. Valeant is now free to begin advertising its controversial wares through "education awareness" campaigns to convince women that their sex problems are commonplace, and they can rely on a pill to achieve the quality of sex they deserve.

Sex on the brain -- Irving Penn

Their public relations advertising campaign is entitled Find My Spark, offering a sex health quiz and video clips where doctors who see women with low sex drive empathize with those who feel "inadequate -- as a woman, as lovers and as partners". "Information" campaigns with subtle messages such as: "that it is imperative that women be sensitized to this public health problem" are now on the horizon.

Tipping As A Racist Act

"Tipping is actually one of the biggest hoaxes ever pulled on an entire culture."
"It wasn't considered slavery because we would ask our customers to pay tips, and therefore no one could say that they were being enslaved."
"And no surprise, but most of the people who were working in service professional jobs in restaurants and Pullman train cars were African-American."
"There's just nothing good about [the tip system]."
Danny Meyer, restaurateur, U.S.A.

Getty Images     "Tipping is actually one of the biggest hoaxes ever pulled on an entire culture," restaurateur Danny Meyer told Dan Pashman on WNYC's The Sporkful podcast.

Tipping for service is now widespread around the globe. Not necessarily everywhere. Tipping is not done, for example at all, in Japan. Perhaps with the understanding that anyone in a service job deserves a living wage, perhaps not. Could be that tipping in some societies is considered insulting whereas in Western countries where tipping is seen as a customer obligation, those in the service industry feel insulted if the tip is insufficiently generous.

But who might have known the genesis of tipping, and that it grew out of a wholly shameful enterprise? Danny Meyer, that's who. And as a result of his distaste for its inception, as a recognition that it has such an unsavoury past, he set about eliminating tipping as a social and financial-services-compensation custom in his restaurants; the burger chain Shake Shack and the Union Square Cafe in New York City.

For the uninitiated, Mr. Meyer explained how the practise of tipping began. In the United States, of course, where so many diverse customs begin and then spread elsewhere. But more to the point in the aftermath of the Civil War years when the industries associated with Pullman train cars and restaurants succeeded in petitioning the federal government to permit their taking on servers but not paying them a penny for their trouble.

Instead, the generosity of clients of the servers, expressing their appreciation through dispensing small amounts of cash constituted the living wages of people who were unabashedly conscripted into servitude as virtual slaves; an extension of the slave labour that the United States' 18th and 19th Century wealth was predicated upon, only given a whiff of respectability by general consensus.

So if the Civil War was partially based on manumission of black slaves, it was renewed by the tipping public filling the vacuum that employers of blacks left by failing to pay salaries to servers.

Tipping is traced back to 17th century England.   Kevork Djansezian / Getty Images

That may be the underhanded theory behind tipping in America, but it seems there's something awry in the narrative, since according to various documented sources, the emergence of tipping as a practise appears to have taken place in the 1600s, in Great Britain. Business Insider has this to say about tipping:
"The custom originated in Europe, and while its history is not entirely clear, it is commonly traced back to 17th century England. The word "tip" is speculated to be an acronym for "To Insure Promptitude," which was printed on bowls in British coffeehouses."
What is today considered a given started as a purely aristocratic practice — a mere "allowance" that the upper class would offer to the socially inferior."

And the strange thing is, being serviced appears still to strike people in a rather undemocratic manner that they are gentry and the servers are subservient, so in a kind of noblesse oblige inspiration, one tips the socially inferior represented by waiters. Evidently a 2014 study published in Sociological Inquiry discovered that customers in restaurants whether they were black or white reacted in a discriminatory manner while tipping, giving blacks less in tips than they would white servers.

Life As A Psychiatric Disorder

"The insurance companies told the rehabs they would no longer pay for inpatient rehab for heroin, cocaine, or alcohol unless there was also another Axis 1 psychiatric disorder like bipolar disorder or depression."
"I was working in a drug treatment facility when the change happened. Since addicts typically complain of anxiety and depression, a completely understandable emotional response to their toxic lifestyles, it was no problem to add a new label and throw a few psychiatric drugs at their now-[re] labelled 'dual diagnosis'."
Phil Sinaikin, psychiatrist, author: Psychiatryland

"[National Alliance of Advocates for Buprenorphine Treatment has] received donations from pharmaceutical companies; its mission fairly straightforward, to:] Educate the public about the disease of opioid addiction and the buprenorphine treatment option; help reduce the stigma and discrimination associated with patients with addiction disorders; and serve as a conduit connecting patients in need of treatment to the buprenorphine treatment providers."
National Alliance of Advocates for Buprenorphine (NAABT)

Well, that's quite the exchange; help to create a social environment of complete personal exoneration of responsibility for succumbing to addictions : to food, to alcohol, to drugs, to any kind of destructive lifestyle habit, in exchange for a general acceptance that what is involved is not a lack of willpower and the inability of many people to make sensible choices for themselves, but a psychiatric disorder that is responsible for destroying their lives.

And thanks to a collaboration between the psychiatric industry and their counselling services in conjunction with pharmaceutical companies which fund their studies in return for their professional medical opinions diagnosing certain conditions then prescribing drugs purported to have been especially engineered to solve those problems of lack of will power and positive discrimination in choices, an industry servicing those two powerfully mendacious professions is born.

There is a huge demographic evidencing the need for some solution to the pandemic of overweight and obese people, weighing down universal health systems and creating for themselves miserable lives of pain, disease, and early deaths. Over two thirds of American adults are considered overweight, matching the 50%-plus of Canadians who are also overweight. Although the medical profession is beginning to go along with the pleas that people are innocent of having contributed to their impaired health conditions, obesity is mostly a symptom of over-consumption.

Just as alcoholism is a symptom of over-consumption, even while medicine points to inherited familial pre-dispositions, and just as drug-dependency as well symbolizes an entrapment mostly of willpower with, undeniably a certain amount of prescribed exposure in protocols gone dreadfully wrong. The Diagnostic and Statistical Manual of Mental Disorders (DSM), the compilation of recognized health disorders recognized controversially throughout North America now lists Binge Eating Disorder as a mental illness.

Just coincidentally, many of those professionals who write the DSM have financial links to Big Pharma. New "diseases" have a tendency to coincide at the junction where Pharma stands to make huge profits from new drug formulas geared to solve newly-identified mental disorders handily appearing in the DSM. The definition of alcohol abuse has been "upgraded" from the previous edition of the manual, to the point now where in the most current version, DSM-5, craving alcohol itself can scoop up more people to fit the criteria of mental illness.

Addiction psychiatry is a booming business, matched with pharmaceutical companies who just cannot make enough profits to suit long- and short-range aspirations. Rehabilitation of alcoholics traditionally meant that people would seek out sources like Alcoholics Anonymous to enable them to become alcohol-free and leave their dependency behind. But in this new era of combined addiction psychiatry and Pharma, counselling has been set aside for the effectiveness of pill treatment of all those addiction ills.

In the States, the FDA is amenable enough, since unrestrained capitalism is the lifeblood of the economy, so three drugs have been approved for treating alcoholics: naltrexone, acamprosate, and disulfram. Buprenorpine, marketed as Suboxone for opioid addiction, as an example, is a troubling addition to the pharmacopoeia since it is as addictive as the drug it is meant to replace as a curative, and just as difficult to stop using, valued for its own "high".

As for overeating in a society long grown accustomed to easy access to processed foods and savoury snacks available wherever one looks from school canteens to hospital snackbars to street vendors  and car washes, little wonder people are always grazing. Advertising and public relations extolling the virtues of sugar-fat-salt-laden food cleansed of all its nutritional properties encourages people to overeat. Life has become a disease.

The Scent of Blatantly Sinister Hypocrisy

"It was a very conscious strategy. HIV ... was legitimately so terrifying that it was also a good health issue to put up and say, 'Wait, this has to be the urgent priority, as opposed to looking at tobacco control."
"Any partnership with a tobacco company [charitable groups accepting funding from tobacco interests], does provide that company and that industry with legitimacy."
Julia Smith, post-doctoral fellow, Global Tobacco Control program, Simon Fraser Health Sciences faculty, British Columbia

"Being the disease of the century and a preventive disease, AIDS should be 'public enemy No. 1' because of its terminal consequences at every age."
British American Tobacco (BAT) official in Argentina

Simon Dawson/Bloomberg   “The tobacco industry is very sophisticated at protecting its sales, whether in Canada or globally,” a Canadian Cancer Society policy analyst said.

 

That kind of sanctimony sits ill with anyone cognizant of the destructiveness to human health posed by the tobacco industry. And for one of its representatives to  slyly attribute to other health-impairing agents the role of absolutely most dangerous to human health, hoping that no one notices that the statement emanates from the hypocritical mouth of a tobacco-pusher is like an illicit drug seller tut-tutting people jaywalking.

The tobacco industry has gone through a very trying time in the past several decades. Shown by investigators to have known very well how tobacco use endangers human life, the industry kept that knowledge, gained through their own research and never publicly disclosed, to themselves. They have been shameless in their skilled use of public relations and advertising to convince vulnerable people that smoking is cool and sophisticated as a lifestyle habit.

Knowing the deleterious effects on heart and lungs of nicotine as a cancer agent and an addictive substance, the industry geared its advertising to entrap people from a young age. When governments began to realize that public health costs were skyrocketing as a result of runaway cancer rates attributable to nicotine in all its nefarious forms, legislation at every government level, from mandating warnings on cigarette packages to outlawing smoking in public places put a dent in tobacco use, as did raising the taxation rate to discourage smokers.

The trauma of lung cancer and prematurely lost lives led people to finally withdraw from tobacco use in large numbers. And that's when the tobacco manufacturers turned their malicious attention to third world countries in Africa, South America and Asia. Their public relations manipulation of the public never did cease, however, and over the past 25 years the industry paired its financial resources with the cause of battling AIDS and HIV, and funding other look-good charitable causes.

As good corporate citizens what was there not to like in the industry supporting research and support for the battle against AIDS? So donations to HIV/AIDS groups was embraced, along with activism on the part of big tobacco to call on government for greater action to battle the disease. At the same time, downplaying the scourge of tobacco on societal health as nothing compared to the destructiveness of acquired immune deficiency syndrome.

Millions of internal company documents formed the basis of a study that led to a recognition of a surreptitious campaign to white-wash tobacco by focusing on concern for HIV. Philip Morris International sponsored a tennis tour in support of HIV groups, British American Tobacco brought a conference on HIV to Nigeria, while one BAT official responded to a major anti-smoking conference by arguing that it is AIDS, not tobacco, that should be recognized as "public enemy No.1".

Fotolia     One HIV advocate called the former financial links between AIDS groups and tobacco companies a “pact with the devil.”

AIDS groups have, for the most part, decided to reject continued tobacco-sourced funding, a practise characterized by one anti-HIV advocate as making a "pact with the devil", in agreeing to accept that tainted funding. The situation prevails and remains particularly acute in sub-Saharan Africa. Even high-profile public groups who should know better, though, still accept that tainted funding: Philip Morris has given donations of over $100,000 yearly to the United Way of Toronto.

The study out of Simon Fraser University used data from the Legacy Tobacco Documents Library representing over 14 million internal industry records on file and used to prosecute lawsuits against tobacco corporations in the United States. Philip Morris, the study points out, donated to a number of American AIDS groups, sponsoring a patient meal program to the value of $3 million, as an example, through the Virginia Slims Legends tennis and music tour.

As the Framework Convention on Tobacco Control was being put into place the tobacco industry attempted to divert public attention away from simple realities and took to questioning the priorities of the World Health Organization in condemning tobacco use as the vector of a world-wide lung cancer epidemic. Concerts and soccer matches spotlighting AIDS prevention and care was sponsored by British American Tobacco in Argentina at the very time that a major international tobacco conference was taking place there.

It took some time, but eventually HIV/AIDS groups globally understood how they were being manipulated, and spurned further tainting by funding from big tobacco. Even so, their campaign continues in the expanding African market. Tobacco consumption in Africa doubled to 80 billion cigarettes per year, from 1990 to 2010. BAT is listed by South Africa's Centre for HIV/AIDS as one of six "partners", alongside the United Nations and American-government agencies, even while BAT supplies 90 percent of South Africa's adult smokers.

Scientific Disagreements

"This reflects an unusually unorthodox and unprofessional conduct from the journal and seems to be part of a pharmaceutical industry push-back to any critique of the Gardasil vaccine."
"To simply retract a paper which reports a result that one does not like makes a mockery of the whole review process."
Dr. Yehuda Shoenfeld, Tel-Aviv University

When the medical journal Vaccine published a study critical of the use of the human papillomavirus vaccine [HPV] co-authored by two researchers from the University of British Columbia, and led by Dr. Shoenfeld, the response from other scientists was hugely critical of their findings. Their research involved mice injected with the Gardasil HPV vaccine, and they reached the conclusion that the behavioural abnormalities the research mice exhibited might present as reason enough for further research, placing a curb on its use.

Joe Raedle/Getty Images   Academics — some funded by pharmaceutical companies, others by anti-vaccination organizations — are at odds over whether the new study has any value

 

In some Canadian provinces mass programs were inaugurated to immunize girls against the cancer-causing virus, and at a later date, an initiative to immunize boys as well  took place. A highly regarded immunologist regarded the study as one that should never have been accepted, since it was, in his opinion, "really a poor paper". The journal editor, Dr. Gregory Poland, himself a Mayo Clinic scientist, decided to withdraw the study and initiated a second peer review because of concerns brought to his attention.

An unambiguous comment from one of three reviewers whose name was not released, but whom the editor of the journal speaks of as an international expert was particularly scalding in the heat of his proffered opinion that "The paper ... has a seemingly excessive number of gross errors in both methodology and analysis".

The lead author of the paper permanently withdrawn because of concerns relating to claims that appeared unjustified along with a perceived lack of scientific rigour, is rather unhappy about the situation. Yehuda Shoenfeld, known in the field for his research questioning the safety of vaccines, accused Dr. Gregory Poland, the journal's editor, of a conflict of interest. Dr. Poland, it seems has been employed on a contract basis by Merck, the manufacturer of Gardasil.

On his part, Dr. Poland has admitted he is chairman of the safety-evaluation committee for Investigational vaccine trials for Merck, and he also consults for the pharmaceutical company. The Dwoskin Foundation, an American charity known for funding research on possible safety problems with vaccines funded Dr. Shoenfeld's study. Dr. Poland has responded that conflict-of-interest charges were "without basis".

He certainly has placed himself in an ethically compromised position, however. And there is validity in the charge by Dr. Shoenfeld; how can anyone on retainer by a pharmaceutical company objectively act in the best interests of science when his employer's product is being brought into question? It is true that research peers in the field of immunization disagree with the findings of the three researchers who wrote the study in question, but isn't science all about questioning the status quo and looking for answers?

Two types of HPV vaccine are on the market and are considered to be generally effective in prevention of the virus that causes 70 percent of cervical cancers. Of the number of women diagnosed with the cancer on an annual basis, almost one-third die of its effects. Global studies find no indication of serious health safety problems emanating from the use of the vaccines. Infectious-disease, public-health and oncology doctors and scientists have reached unanimity in support of the vaccine.

Christopher Shaw of University of British Columbia's ophthalmology department and post-doctoral fellow Lucija Tomljenovic, known for work linking vaccines to neurological problems are the two UBC researchers who contributed to the HPV paper. Dr. Shaw points out that the second round of reviews of their paper brought to the fore some valid points that could have been addressed if the authors had been given the opportunity.

"It is pretty hard to ignore the subject of the article (Gardasil) and Dr. Poland's ties to Merck", he commented. He's right there. The value of the study's observations and recommendations may be in question, but there is little question that Dr. Poland has effectively neutered his own scientific credentials through his work with the pharmaceutical giant. Caesar's wife must be above suspicion. And any scientist who prides himself on the quality of his work should also take care not to compromise perception of that quality.

The three researchers who produced the paper now withdrawn from publication are considered to be outliers in the scientific community linked to immunization and the safety of vaccines. "It's one thing when a member of the public stands up on a soap box. (But) this is irresponsible science by scientists. These are people who have PhDs behind their names ... It causes fear", points out Dr. Monika Naus, medical director of the B.C. Centre for Disease Control immunization programs.

Getty Images   A single dose of the controversial HPV vaccine

Darwinian Selection

"We've got to do something."
"I'm not an academic, not an an advocate, but when I have the data in my hands, I feel a moral responsibility to make it known." 
Rob Schwartz, executive director, Ontario Tobacco Research Unit

"We need to bend that curve [of societal smoking cessation].  There's a sense in some communities that ... 'Well, we've been there done that, it's fixed'. But the data don't support that."
Dr. Elizabeth Eisenhauer, oncologist, Queen's University, Kingston

"They're just engaging in strange, authoritarian fantasies. The ideas are harmful, they are a distraction from thinking about things that will actually work."
Clive Bates, (former) head, Action on Smoking and Health, U.K.

Dusan Vranic / The Associated Press file photo

A bill to be introduced by the Liberal government will not only ban smoking in outdoor places such as restaurant patios but also ban sale of tobacco on college and university campuses, among other things

Re-thinking strategy. The  struggle to inform and educate the public about the well-enough-known harms of tobacco to the human body has in fact resulted in a wide public acknowledgement that smoking is a leading cause of serious health conditions, from cancers to heart attacks. Smoking cessation programs have succeeded in helping smokers surrender their addiction to tobacco. The incidence of nicotine-caused morbidity has dramatically decreased over the years.

The general public is well versed in the harms done to it by active and passive smoke inhalation by  this notoriously dangerous carcinogen. Yet a hard-core segment of the population addicted to tobacco use in its various forms has been unable to reduce their dependency on smoking and remain at risk within society. And another vulnerable group is young people who view smoking as cool and a tool of defiance against society's accepted mores.

Ed Kaiser / THE CANADIAN PRESS FILE PHOTO

A study has found that smoking is dropping among Ontario youth. In 2014, 6 per cent of students in grades and 11 and 12 — an estimated 24,500 pupils — had smoked cigarettes in the past 30 days, compared to 12 per cent in 2005

Through a number of working expedients such as raising taxes on cigarettes, to legislating graphic warning labels and public smoking bans, governments at all levels have succeeded in radically reducing smoking rates in Canada from its 1965  high of 50 percent to the current 15 percent dependence and usage; a signal success by any measure, most particularly the measure of cancer rate reduction. That success rate, however was reached by 2009 and has since not shifted downward.

The realization has set in that if the full round  of control measures recommended by the World Health Organization, such as even steeper tax hikes on tobacco products, and resorting to plain cigarette packaging for example, were to be implemented, the number of dedicated smokers would still fall at most to about 12 percent by 2035, according to Rob Schwartz.

In Canada, the aspiration is to arrive at "five by 35", interpreted as a five percent smoking rate hoped to be achievable by the year 2035. Academic  researchers and experts representing health charities along with anti-smoking activists and government representatives are set to meet at a fall 2016 conference to discuss the situation of further reaching out to convince millions of people who remain smokers, to discard their self-injurious habit.

It is habit that costs society dearly, from lost workplace hours, to heavy financial burdens on a universal healthcare system, let alone the tragedy of preventable early deaths. Endgame tactics are to be discussed such as mandating lower levels of addictive nicotine manufactured into cigarettes,  altering the pH balance for greater acridity, limiting sales through tobacco licensing, or prohibiting those born after 2000 from smoking altogether.

These are the proposed remedies born of desperation. And, as pointed out by Clive Bates, formerly chief of Britain's chief anti-smoking group, would lead to resistance, ushering smokers toward contraband products on a grand scale. Educating and encouraging people to take steps to protect themselves from the dread consequences of serious health impacts is one thing; imposing restrictions thus cutting off free choice to those who find a gamble with the quality and longevity of their lives a personal matter, entirely something else.

One life: yours to live it to best advantage; yours to defy the odds and live it as found personally pleasing and damn the consequences.