Our Views

It’s been more than two years since FDA scientist David Graham told a Senate panel that the FDA was “incapable of protecting America against another Vioxx.” Now he tells a House panel that “nothing has really changed.”

20-year veteran FDA scientist told the House Subcommittee on Oversight and Investigation recently that the FDA is “incapable of protecting America against another Vioxx, and that since then nothing has really changed” in the FDA’s approvals process.

The subcommittee, chaired by Bart Stupak (D-MI), has been engaged in a series of hearings to evaluate the FDA’s ability to safely approve new drugs and provide post-marketing surveillance, with a jaundiced eye aimed at Big Pharma as well. The hearing was titled: “Ketek Clinical Study Fraud: What Did Aventis Know?”

Dr. David Graham told panel members that the FDA’s Center for Drug Evaluation and Research (CDER) “regards industry as the agency’s main client” rather than considering broad public safety as its mandate. It was Graham’s testimony in 2004 that helped lead to Merck’s arthritis drug Vioxx being pulled off the market in September of that year. Asked about other drugs that the FDA has mishandled, Graham told the subcommittee that atypical anti-psychotic medications to sedate nursing home residents kill roughly 15,000 people a year, and that the weight gain and diabetes dangers posed by Zyprexa, used to treat schizophrenia and bipolar disorder, was known for years to Eli Lilly, the drug’s maker.

Another physician, Dr. David Ross, who has worked on the CDER’s pre-approval side for a decade, said that the antibiotic Ketek, made by Sanofi Aventis, was approved in spite of the fact that the FDA knew it could “kill people from liver damage and that tens of millions of people would be exposed to it.” Ross testified that his FDA bosses forced him to ease back on his unfavorable review of Ketek.

The antibiotic Ketek, approved in April 2004, has been linked to liver failure and other adverse side effects, and the FDA announced in February that Ketek was no longer approved to treat sinusitis or bronchitis because its potential risks outweigh any benefits for these fairly benign conditions. It remains on the market to treat only pneumonia acquired outside a hospital or nursing home.

Mark Senak in his EyeOnFDA blog says the FDA is “in the stew”, and that the FDA leadership “may not believe that they are running for office. They are mistaken. They are running for an office called public confidence. And right now, as for the past few years, the agency is losing that essential race.”

Clearly there are problems with the FDA’s approvals policies and post-marketing controls. When you add Big Pharma’s propensity for unethical practices into the mix, such as withholding or altering clinical trial data, there is no question but to bring about serious changes in the way drugs are tested, reported and approved for public use.

Anything else continues the betrayal of public trust.

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“Pharmaceutical representatives often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by these sales representatives.” (Senator Herb Kohl, D., Wis.)

There are few people who want to see an end to Big Pharma’s massive sales force more than Big Pharma leaders themselves. In his blog, Life Sciences Chronicle, more than 6 months ago, and again a few weeks ago in MedTech Futures, a regular feature at MidwestBusiness.com, industry watcher Dr. Ogan Gurel echoed Big Pharma’s concerns that the sales program is simply unsustainable.

“From direct personal experience,” Dr. Gurel says, “I know that many top pharmaceutical executives are keenly interested in solutions to the problem rather than sustaining what is ultimately an unsustainable arms race.” Big Pharma wants to get back to the business of bringing innovative medicines to the public, he says, rather than trying to sustain massive sales teams.

Created to promote prescription drugs to physicians, the sales rep program has bloated to an estimated cost of $20-billion-a-year and 100,000 sales reps knocking on doctors’ doors day in and day out across the country. Its value to the industry is in serious question by everyone concerned.

Herb Kohl (D., Wisconsin), chairman of the Senate Special Committee on Aging, along with Sen. Chuck Grassley (R., Iowa), recently introduced a bill requiring Big Pharma to report all payments and gifts made to physicians. News reports said some Big Pharma companies welcomed the idea, and at least one was already doing so.

But things could get worse, rather than better, if a proposal for federal grants to counter Big Pharma’s sales efforts are approved. This past March, Sen. Kohl said he and Sen. Richard Durbin (D., Illinois) would introduce legislation to encourage “counter-detailing” grant programs.

Counter-detailing, or “academic detailing”, is the name for efforts, often made by medical insurers, to counter Big Pharma’s sales pitches, including its massive sales rep program which is referred to as “detailing.” Counter-detailing pushes doctors and patients toward cheaper generic drugs, and even tries to discredit Big Pharma’s claims about their more expensive branded products.

The grant programs would help create training materials informing physicians about safety issues and comparative effectiveness of different medications, and send trained health care professionals to physicians’ offices to provide the information to physicians.

These ideas could be worse than doing nothing at all. Government-subsidized attacks on Big Pharma brands would hit Big Pharma right in the pocket-book, resulting in even more money poured into its sales forces to compete. There seems little chance that the government’s counter-detailing would support branded products, helping Big Pharma ease up on its sales forces.

Neither of the Kohl-backed bills does anything to effectively replace the bloated and unsustainable drug-rep business model with a viable alternative — one that actually informs physicians about the efficacies and safety issues of both generic drugs and Big Pharma’s branded products (without all the expensive baloney of the sales rep program) while increasing real and predictable patient safety.

What’s needed, and where the government should put its money, is into rebuilding the FDA’s approvals and aftermarket safety programs with sensible and effective policies that help Big Pharma to get more innovative drugs into the pipeline, providing the kind of thoroughly tested and ethically marketed drugs that people need, want, expect and, by their recent actions in the courts of America, are now loudly demanding.

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Reacting to reports of deaths, injuries and continuing law suits due to prescription drugs, Rep. Rosa DeLauro, D-Conn., is calling for major improvements to the drug review system at the Food and Drug Administration.

Congresswoman Rosa DeLauro, D-Conn, plans to use her clout as chairwoman of the House appropriations panel responsible for FDA funding, to improve drug safety — and it’s about time someone took the situation seriously.

Calling top agency officials simply “incompetent” over the recent crisis involving the blood-thinner drug heparin in which at least 19 people have died, DeLauro said real change can occur only with a new administration.

DeLauro was quoted in the media saying the FDA “is an agency that is charged with safeguarding the public health, but it’s being run like the keystone cops.”

In the heparin crisis, caused by contaminated ingredients from a Chinese factory, the FDA became aware of the problem only after hundreds were sickened and deaths had occurred. Of course, Congress announced an investigation.

This whole affair shows how little has changed at the agency in nearly a decade. In 1999, a contaminated antibiotic manufactured in China killed at least 17 people before the FDA took notice, and, as usual, Congress investigated. Ho-hum.

Mark Senak, commenting in a recent blog on the terrible first quarter the FDA is having, included DeLauro’s “Keystone cops” quote as one of the indications of trouble at the agency — a heavily funded, understaffed and apparently under-talented federal agency who’s single mandate is to protect the health of Americans, a job it is failing to do effectively enough.

The FDA has itself admitted it violated policy by failing to inspect the plant in China. But according to a New York Times report, drugs imported from China have soared since the last China drug scandal, while the FDA’s inspections of overseas drug plants have dropped significantly. Of the 566 plants in China that export drugs to the US, the agency inspected only 13 of them last year. The story is the same in India and other countries that make drugs or drug components for Big Pharma.

Last week Congress called on the FDA to move faster in forcing drug companies to include in their “direct-to-consumer” advertisements that flood TV every night ways for consumers to report drug side effects to the FDA. The agency tracks so-called “adverse drug events” — meaning drug side effects — and uses reports from doctors and patients to address safety problems with drugs already on the market. But because the system is voluntary, agency scientists complain, it misses the vast majority of drug reactions that occur.

“When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing,” DeLauro said. She stated her priorities are: Improving the FDA’s handling of post-market drug safety reviews; direct-to-consumer advertising; sufficient funding for generic drug reviews; addressing the agency’s advisory committee conflict of interest policies; improving device oversight; handling drug importation; and renewal of agency user fees.

Let’s keep our fingers crossed that DeLauro and company remain in place through and after this November’s election.

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Product safety issues for 10 percent of Big Pharma’s total prescription market were among several factors leading to significantly lower- than-expected sales last year.

Although Big Pharma experienced a 3.8 percent sales growth in 2007, representing $286.5 billion in prescription drug sales, the rate of growth was down from 8 percent in 2006, and marks the lowest growth rate since 1961. According to a report from pharmaceutical marketing consultants IMS Health, product safety issues were among the reasons causing the slump.

IMS attributed the drop in sales to these primary factors:

• Loss of exclusivity of branded drugs to generics, which now hold nearly 68 percent of the market
• The fewest new, innovative drugs approved in 3 decades (and slowed physician adoption of new medicines, too)
• Slowing of Medicare Part D prescription drug business as that program matures
• The repercussion from mounting drug safety issues

Safety issues included a significant number of “black box” label warnings, as well as a number of important product withdrawals. The FDA also raised safety concerns about other products in the erythropoietins, diabetes and antidepressant therapy classes. Overall, says the IMS report, safety issues contributed to “significantly lower- than-expected sales, accounting for approximately 10 percent of the total prescription market.”

In his great blog, Eye On FDA, Mark Senak poses some interesting questions about the situation, suggesting that if the drop in product approvals isn’t because of the FDA’s backlog (which are due at least in part to staffing shortages), it could be increased concern over product safety:

“One can truly see one of the many impacts of the fact that the agency has issued more approvable letters in 2007, to a degree shutting down the pipeline, impacting the market, patients and stockholders. This of course, leads to the question whether or not this is a product of (i) a risk averse environment, or (ii) products have suddenly gotten bad, or (iii) the FDA has purposely slowed things down so that it can catch up.”

(“Approvable letters” are notices to drug makers that new products can’t be approved until additional actions are taken, usually in the area of more studies and testing.)

My thoughts are plainly this: Anything the FDA wants to do to beef up and improve testing before approving new drugs is okay with me. And I’m sure with the American public too, who are fed up with all the injuries, deaths and massive lawsuits stemming from incomplete, shoddy and even unethical testing and reporting — not to mention unethical marketing — that for too long has put the protection of profits and investor confidence ahead of consumer protection and confidence.

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Replacing unethical marketing with evidence-based science could, in the longer term, put a lot of money back into Big Pharma’s R&D pocket.

Shahram Ahari, the former Ely Lilly sales rep who went public with his tales of how Big Pharma’s marketing tactics target doctors with everything from gifts to possible sexual favors (see our earlier blog) has joined the group PharmedOut, an independent, publicly funded project that wants to help physicians identify and counter Big Pharma’s inappropriate pharmaceutical promotion practices. The group has released a free, web-based Continuing Medical Education (CNE) course to educate doctors about generic drugs and the drug approval process.

PharmedOut also wants to see unethical marketing replaced by evidence-based science — something we’ve been saying all along. If the Food and Drug Administration’s drug testing and approvals system ensured that Big Pharma’s products were thoroughly tested before releasing them, these kinds of marketing tactics could become unnecessary.

PharmedOut is being funded by money from a 2004 legal settlement between Warner-Lambert, a division of Pfizer, Inc., and the Attorneys General of 50 States and the District of Columbia over allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin. But according to some comments at the blog PharmaGossip, this kind of funding may be tainted because it comes, however indirectly, from Big Pharma. And after it’s gone, how will funding continue?

Regardless of PharmedOut’s funding, its intentions seem on the money. Reliable drug testing and full disclosure would remove doubts about a drug’s efficacy or safety, doctors would be free to prescribe a drug with more certainty, and the public would benefit from better drugs and lower health care costs.

Such a system would see Big Pharma having to continue spending hundreds of millions of dollars developing a drug — that’s a given that won’t change. But it could save a lot of the $7 billion it spends trying to sell its drugs to doctors — roughly $8,800 per physician — in a market place already glutted with poorly-evidenced drugs. That money could be ploughed back into R&D budgets already pinched by patent expirations and competition from generics.

Even more R&D money could be derived from efficient, longer-term testing and approvals. Better tested drugs could save billions in legal settlements over drugs that turn out to be less than perfectly safe, and more billions in settlements over Big Pharma’s corporate and executive culpability for crossing legal and ethical lines promoting poorly tested and under- or falsely-reported test results.

The ideal of evidence-based science driving prescribing decisions can only come about if the onus is placed back on Big Pharma, the FDA and appropriate lawmakers to develop better, safer testing and approvals. However difficult it may be, there is no other way to get some shine back into Big Pharma’s tarnished image. It could be what’s needed to save the industry from the extinction it surely faces without some fundamental changes.

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Two former pharmaceutical sales reps have blown the whistle on unethical tactics used by Big Pharma to curry favor with physicians, raising health care costs and doing no real good for patients.

Two former Big Pharma sales reps who regularly visited doctors to promote their company’s prescription products have gone public with claims of everything from free gifts, dinners, trips to strip clubs and even ‘sexual tension’ to manipulate America’s doctors into prescribing more of their products, saying reps were chosen for their attractiveness, not their product knowledge or scientific training.

Shahram Ahari, a former Eli Lilly sales rep, told medical students at Tufts, Harvard, and Massachusetts General Hospital recently about how the future doctors can resist the slanted sales pitches. Ahari also discussed the unethical nature of drug sales with Jim Braude of New England Cable News (NECN) in a video recently, and his claims are downright shocking.

Ahari, now at the University of California-San Francisco School of Pharmacy, who has testified before Congress on the situation, told NECN that reps were chosen for their looks and charm, and if doctors appeared to be attracted to the rep, that rep should ‘exploit’ the situation. He said he has no info on how far such exploitation might have gone, but he knew that doctors were routinely treated to expensive dinners, all-expense-paid trips, and even visits to strip clubs.

Ahari tells more of his disturbing story about selling the controversial drug Zyprexa in a video on the YouTube website. And another former Big Pharma rep, Gwen Olsen, has also uploaded a series of confessions about her unethical sales tactics to YouTube. Similar to Ahari’s revelations, she reveals a shocking lack of ethics and a willingness to exploit and manipulate physicians with little or no regard for patient safety by Big Pharma’s sales reps.

The Physician Payments Sunshine Act, introduced by Senators Chuck Grassley and Herb Kohl, will require drug and medical device makers to report gifts, honoraria, cash and free services made to doctors. The bill was proposed because of worries that Big Pharma’s marketing practices add to already skyrocketing health care costs and are not in patients’ best interests.

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One new development in Washington this week clearly shows that we’re not alone in our call for Big Pharma reforms.

Republican Sens. Chuck Grassley and Herb Kohl have introduced a bill that requires drug and medical device makers to report to the federal government the value of free services, and almost every penny, they provide to doctors. Anything over $25 would have to be reported quarterly and would be posted on a government website for all to see.

For several months, Congress has been looking into the millions of dollars that flow from Big Pharma (and smaller pharmaceutical makers too) to America’s physicians, for everything from speaking engagements and consulting fees to golf weekends, travel and free meals.

There is some question about how, or even if, this practice influences what drugs doctors prescribe, because this seriously affects health care costs. The price of a cheap generic vs. an expensive brand drug, times the billions of prescriptions written every year, makes a huge difference in the health care bottom line.

In our view, there’s absolutely no doubt that Big Pharma’s physician bribery program sways prescribing practices. If it wasn’t working, Big Pharma wouldn’t keep on shelling out the millions of dollars to doctors. According to reports, some individual doctors have actually been paid hundreds of thousands a year in such gifts or fees-for-services.

The practice also raises the fear of potential patient harm from being prescribed drugs they might not need, or that may not be exactly what is needed.

Said Sen. Kohl, the bill’s co-sponsor, “At our June hearing, the pharmaceutical industry told the Aging Committee that they believe their practices are above-board. If that is the case, full disclosure will only serve to prove them right. If that is not the case, full disclosure will bring their influence-peddling out from the shadows. Either way, patients win.”

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When you think you’re near death in an ambulance rocking through the midnight streets with sirens wailing and the paramedics are trying to save your sorry ass, you are likely to suspend at least for the moment any problems you might have with Big Pharma

Some years ago I unexpectedly found myself – well, who ever expects it – on a gurney in a big red ambulance rushing through late-night rain-slicked city streets, possibly dying of a heart attack. As we careened around corners, sirens wailing, a couple of calm and earnest paramedics were putting an oxygen mask over my nose and mouth, attaching wires to my chest, and sticking needles in my arm.

I remember thinking briefly about how I was a devout believer in the evils of Big Pharma and that no mysterious chemicals would ever be allowed into my veins. Let me tell you, my friends, that was a very brief and fleeting thought. The choice between meeting my Maker and taking a flyer with Big Pharma was a no-contest.

In the years since that traumatic midnight ambulance experience, Big Pharma has come to personify more than ever the ultimate in corporate greed and ethical expedience – that means ethics flexibly convenient for the situation. Reams of media exposure about overt scientific fraud, misinformation and illegal marketing abuses, safety scares and recalls, thousands of injuries and deaths, and massive law suits have solidified that view.

Governmental and regulatory collusion to subvert the market and prevent consumer litigation has only accelerated distrust of our lawmakers. Imagine your wife, husband or child turned into a blood-thirsty zombie by some badly-tested and ill-approved pharmaceutical, only to discover that you’re legally prevented from seeking justice in a court of law. That’s not a situation we want to face.

Even the peer-reviewed scientific literature can no longer be fully trusted. Major medical mags have continued to publish test results that were either flawed or outright tampered with to make so-so drugs look better than they are or to hide seriously dangerous side effects.

The media has jumped on the bandwagon too. Major magazine stories, newspaper articles, radio and television shows, even popular films such as The Constant Gardener and Michael Moore’s Sicko, have only pounded Big Pharma’s tarnished reputation even more.

Big Pharma, which began in antiquity as our shamans, our gurus, our feared and respected witch doctors and healers – those who possessed mysterious knowledge about the substances that can alter and heal our bodies and minds – is no longer the respected provider of all that is life-saving, life-affirming – and even life-taking when considered necessary.

Big Pharma has morphed from ultimate healer to ultimate destroyer, a role never imagined by the first Australopithecus who stooped to taste a handful of wild berries and, head spinning, perceived all the wonderful possibilities.

What is needed now is a full examination of the disease that has brought Big Pharma to its knees, a condition for which there is no quick fix from a potion or pill. We need an official investigation of all concerned – lawmakers, regulators, drug testers and Big Pharma itself – one that will lead us to recommendations for saving this industry from melt-down, and help prevent future public drug disasters too.

The investigation should look at two main areas:

1.    An overhaul of common procedural practices for drug testing performance, reporting and approvals, to remove any possibility of the substandard results we are unquestionably suffering from now;

2.    A ramp-up of enforcement of all the codes of ethical conduct governing business and government, important beyond measure for an industry that holds the power of life and death in its hands – and that’s not some catchy slogan, folks, that’s our lives and our deaths, yours and mine.

With such a plan of action, perhaps we can return to this once-vital industry the productivity and continued expansion it needs to sustain research and develop safer and even more effective and life-saving new drugs, while weaning out and discarding those that are only marginally helpful, unhelpful and outright dangerous.

And like those incredible paramedics years ago on my first ambulance ride, along with the ER nurses and doctors who later toiled solely and selflessly on my behalf – maybe Big Pharma can recover the support and respect that any dedicated life-saving activity truly deserves.

In our activity of providing medical drug detox services, we have seen a major shift from illicit street drugs to prescription drugs from Big Pharma. I invite you to share your comments, ideas and experiences with or about Big Pharma and your prescriptions.

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Unless you’re a cave-dweller in some remote and undiscovered mountain retreat, you’ve been touched and will be touched by pharmaceuticals in one way or another.

A storm has gathered around Big Pharma, and something needs to be done about it because we’re all involved. From the cradle to the grave, we all look to our drug companies for help and protection against unwanted conditions and disease.

But all that is changing. Trust in our drug companies is waning or gone. More and more people are looking elsewhere for the help they need. Interest in alternative medicine has never been higher.

With patents expiring on some of their biggest money-makers, the essential profits the drug companies need to research and deliver new drugs in the coming decade are seriously threatened. Added to this scenario are the dozens, perhaps hundreds, of record-setting legal settlements over thousands of drug injuries and deaths. The public and even health care professionals are more than concerned about withheld and falsified drug testing results – and many are mad as hell.

Even investors have joined the dispute and are suing at least one Big Pharma company, ticked off that their cozy blue-chip nest-eggs are turning moldy around the edges because corporate misbehavior and mismanagement has stock values plummeting.

Who is Big Pharma Anyway?

Those new to the storm around Big Pharma might be asking, “Who or what is Big Pharma anyway? And why should I care? I seldom even take an aspirin.”

You should know coming into this discussion that the Big Pharma storm is nothing if not globally significant because of the impact this trillion-dollar industry has on our lives economically – never mind the problems about financing research and development of new drugs at a billion dollars a pop. Yes, it costs roughly a $billion in R&D for every drug that reaches the market.

Big Pharma is the nick-name of a collection of two dozen or so immensely rich and successful multinational corporations that make nearly all the drugs we rely on to get us over the rough spots in life, to help and heal us, and to save our lives when the chips are down. You can check out Wikipedia to see a list of their names. You’ll see 50 companies on that page, and it’s a very good chance there’s not a house on your street that doesn’t have at least one container with one of those names on it.

The originally derogative – but that may be changing – “Big Pharma” nickname was coined when the giant drug-makers began to be perceived a decade or more ago as 19th century snake oil salesmen earning obscene profits at public expense, rather than as the healers and saviors they once were.

Perhaps some day, Big Pharma could be seen again as helpers and healers, if the right steps are taken to fix the right problems. In coming blogs I will be looking more closely at the problems facing Big Pharma, and reviewing news and developments concerning this vital industry.

Big Pharma has had an enormous impact on our activity of providing medical drug detox services to an exploding population of people suffering from prescription drug problems.  I invite readers to share your comments, ideas and experiences with or about Big Pharma and the problems it is now experiencing.

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Years of working in the field of alcohol and drug detox and rehabilitation has taught me many valuable lessons about people, and about the addictive substances to which they sadly, and so often disastrously, fall prey.

But it has revealed another situation, a darker problem more serious even than individual addiction because it strikes at and threatens the beating heart of our society.

This problem, which like most problems began as a solution, has created an entirely new culture in the world, a broad social order touching all of us that looks not for real solutions to the difficulties of modern life, but rather for a quick and simple escape. This new culture that has been thrust on and widely accepted by the world is the culture of pharmaceuticals as the solution to all ills, mental, physical and even spiritual.

While many people might just shrug and ignore the situation, we in the drug detox and drug rehab arena can’t turn our backs on it. The situation has become so perilous that for the foreseeable future the Novus Medical Detox blog space will be dedicated to investigating, reporting and commenting on it.

The reasons for this seem clear beyond any argument. The good that so many pharmaceuticals do colors how we think of them, how we use them, and how we abuse them. It is also clear that the investor-driven rush for profit has led to woefully inadequate testing and approvals of many new drugs, largely contributing to thousands of unnecessary injuries and deaths, and billions of dollars in legal settlements at a time when Big Pharma can ill afford such problems.

Recently we have read about Big Pharma’s admissions of altered or withheld test results, and profiteering at the expense of its patients and customers. And unethical promotion of risky off-label uses for the sake of profit have also raised the grim statistics of injury and death by drugs.

No one is suggesting that Big Pharma shouldn’t make a profit. Without profit there could be no research, no new developments, no progress at all. Instead, we seek to find what can and should be done about the shortcomings in pharmaceutical testing and approvals, to help remove the dangers of unproven drugs from society, without placing impossible financial burdens on Big Pharma.

Starting today, this blog will center on the complicity of Big Pharma, the Food and Drug Administration, state and federal lawmakers and of course the over-arching influences of Wall Street and an ad-hungry, uncritical media in the indiscriminate and dangerous drugging of society. We will examine the profitable to some but costly to society results of blind acceptance of pharmaceuticals as a panacea, and the dwindling spiral into widespread chemical dependence, addiction and death that has accompanied it. We will also look at the possibility that improved testing and approval processes, although more costly at first, might actually be the solution everyone is looking for.

From time to time we might also suggest, when it’s reasonable and has some scientific merit or historical precedent, how people might turn to simple, more natural solutions than poorly tested and potentially risky pharmaceuticals. In the dim past, there dwelt a sense of awe at the discovery of nature’s power to heal. A glance at history shows how leaves, roots, barks and herbs led to a compelling desire to harness nature’s power to help one’s fellows find healthier, more comfortable lives. This is the actual history of Big Pharma. And we hope that the readers of this blog will participate with us in that original spirit of discovery, and share our commitment to help in whatever way we can to bring about the well-being of mankind.

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