Why FDA Approval?

With the desperate search for a coronavirus vaccine and medicines to reduce the seriousness of the disease comes a lot of discussion about FDA approval. One side argues that speed is of the essence and we need to accelerate the process. The other side argues that we can never be sure of a drug’s effectiveness without proper testing. (This will reflect some of the information from last week’s entry, “Understanding Experiments.”) 

The FDA admits, “It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf.” The first step requires about three years of laboratory testing before testing on humans. “Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.” 

Next comes a three-phase process. First they must test for safety. Next they need 100 to 300 volunteers to test for basic effectiveness. Finally 1000 to 3000 patients in clinics and hospitals are monitored for effectiveness and to identify adverse reactions. Each phase can easily take years to complete. (And some people wonder why drugs cost so much and why the companies fight and scheme to protect their patents.)

In the interim some drugs that have been previously approved for other diseases are being tested on coronavirus patients. This practice of prescribing drugs off-label is really quite common in the US. WebMD writes, “Off-label prescribing isn't necessarily bad. It can be beneficial, especially when patients have exhausted all other approved options.”

This is why FDA approval is so valuable and why makers of so many pills, salves, ointments and medical devices are so eager to try to take credit for having cleared this hurdle. Otherwise the law requires them to post the familiar disclaimer: “The statements made regarding these products have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.” (But the disclaimer is familiar only to those who bother to read the fine print.)

If companies fail to do this, it’s not the FDA but the Federal Trade Commission (FTC) that comes after them for misrepresentation, as they did in this case – one of many that show up almost weekly.

“Under a settlement with the Federal Trade Commission, the marketers of an electrical nerve stimulation device called Quell have agreed to pay at least $4 million and stop making deceptive claims that the device treats pain throughout the body when placed below the knee and is clinically proven and cleared by the Food and Drug Administration (FDA) to do so.” (From an FTC press release.)

I checked their website and found that they no longer show the device as FDA approved (to treat or cure), but still do try to give that impression through endorsements and research posters. They continue to mention the FDA at least twice on the site, referring only to registration, not approval – big difference. In summary, the “FTC alleged that the defendants lack scientific evidence to support widespread chronic pain relief claims…” but the site lists no such disclaimer. It’s big business and a $4 million fine pales in comparison to a $350 million development cost.

That it is “100% drug free and non-surgical” while it “stimulates sensory nerves with safe and precise electrical pulses to trigger a natural pain relief response” appeals to people with chronic pain trying to avoid addictive drugs. It’s understandable how such a device would tempt people, and if placebo does the trick it might be worth $300 plus an on-going expense for fresh electrodes.

Like so many other health and medical decisions, avoiding such questionable products is all about a little research and critical thinking.

More Food For Thought

Almost three years ago I wrote about the widely advertised supplement, Prevagen. The Federal Trade Commission (FTC) challenged the company’s claims about the product’s safety and effectiveness in improving memory. That FTC action followed a number of warning letters to the company from the FDA expressing similar concerns.

Supplements in general cause regulatory headaches for the FDA. “In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise.” (I wonder how many lobbying dollars were spent on that law.) The government may stop a company from selling a supplement if they can prove it “poses a significant risk,” that is, usually “only after they cause harm” to customers. Even then they may face a fight.

Because they are not drugs, rigorously tested for safety and effectiveness, at the end of their advertising they are required by law to carry the disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease." Many get around this by making weak promises such as the supplement reduces the risk of certain health problems or it promotes a healthy condition. 

As far as that one and others that claim to improve memory, the Alzheimer’s Association finds such products, not approved by the FDA to be particularly troubling. “One of the biggest problem areas for unsubstantiated claims are dietary supplements...that claim to be beneficial for Alzheimer’s or other dementia symptoms.” But the promotion of these products and introduction of new ones hasn’t slowed down. “In the past five years, the FDA has issued more than 40 warning letters to companies illegally marketing over 80 products claiming to prevent, treat or cure Alzheimer’s disease.” Furthermore, the FDA recently warned that cognitive enhancement supplements “may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment.”

Now the problems and dangers surrounding the sale of supplements to prevent memory loss or to improve memory has been raised again in the November issue of JAMA Internal Medicine. A research team tested for the presence of Piracetam, a supposed brain-enhancing substance that “is not approved as a drug and is prohibited as a dietary supplement ingredient in the United States.” They found inconsistent labeling with errors ranging from 85% to 188%. This substance has known adverse effects including: anxiety, insomnia, agitation, depression, drowsiness, and weight gain.

These marketing techniques are truly unconscionable. They make every attempt to prey on older Americans who are already scared at the prospect of contracting some form of dementia by the ads, news stories, shared experiences of friends and personal experience with elderly relatives. Some are concerned about the prospect of mentally fading away. Others worry about being a burden on their family. 

Feelings of anxiety every time a name or fact is not at one’s finger tips make it easy to fall into the trap of buying these unproven products with the hope that maybe it really works. Action of the placebo effect on friends and acquaintances whose minds have fooled them into believing in it compound the problem. But reading and understanding the fine print that follows the ads and knowing that now there's a possibility of some products being adulterated with unapproved drugs should act as sufficient deterrent to critical thinkers.

Can You Trust Your Pharmacy?

A recurring comment in the script of an episode of an old TV Western (Maverick, 1958) was the line, “If you can’t trust your banker, who can you trust?” The modern day equivalent of that could well be, “If you can’t trust your pharmacy?” This is nothing against the pharmacists, who studied hard to be licensed. There is no evidence of them not giving accurate advice. The displays in the store itself along with some other corporate and industry practices, on the other hand, can and do imply things that aren’t true. Two recent news items act as a good reminder.

The first is about an on-line survey of 1000 Americans published in August, sponsored by the Center for Inquiry (CFI) and conducted by Lake Research Partners. The survey centered on people’s general trust in their pharmacy at Wal-Mart and CVS, and more specifically their feelings regarding homeopathic medicines at those pharmacies.

They chose these pharmacies because both corporations face a lawsuit over their practice of selling homeopathic medicine side by side with science-based remedies. CFI believes it is deceptive to imply that they are as effective as regular OTC cough, cold and other remedies, when they have “no medical benefits beyond that of a placebo.”

There is, in fact, broad agreement on this point. “After a thorough and extensive review of over 200 research papers on the subject, the National Health and Medical Research Council (NHMRC) [of Australia concluded in 2015]:  “There are no health conditions for which there is reliable evidence that homeopathy is effective.” (For a thorough explanation of homeopathic medicines click the link.)

That survey of Wal-Mart and CVS customers asked them about how they make their purchasing decisions for cough, cold, and flu remedies at the two stores “and about their general knowledge of the basic principles of homeopathy, an 18th-century pseudoscience that has been utterly disproven.” The survey showed that exposure to this new information about the failures of homeopathy in so many independent studies led consumers to have to negative feelings about the products and the companies selling them. More than 4 in 10, “described their feelings about the purchase of a homeopathic remedy in deeply negative” terms.

Remember, one of the companies, CVS, still talks about how proud they are of the decision to discontinue tobacco products five years ago and believe it shows their concern about the health of their customers. Tobacco sales were profitable, but ultimately stood in the way of them being considered “a trusted health care provider.” According to their CEO, they strive to be in the same class of business values as TOMS shoes (which donates shoes to African countries providing unfair competition to African small businesses trying to survive by selling shoes – but that kind of unintended consequence is a topic for a different time). If they value their reputation for being a healthcare resource, one would think they would be as concerned about the accurate representation of their products.

But if you can’t trust your pharmacy about the product displays, what about the prices?

That leads to the second news item. A lawsuit filed in August by PharmacyChecker.com accuses “The National Association of Boards of Pharmacy (NABP), LegitScript, and three Pharma front groups [of] operating a coordinated campaign to suppress market competition, artificially inflate the price of prescription drugs, and spread misinformation to scare consumers away from international online pharmacies.” 

PharmacyChecker.com verifies the reliability of international online pharmacies and compares their drug prices to allow consumers to be confident about their on-line purchases and to inject competition into the prescription drug market. They allege in the lawsuit that those organizations have conspired with Google, Microsoft and others to lower their page on search results and in some cases to display a warning box when the page is opened.

Companies and industries do many things to protect their business and to make a profit. Consumers have to do many things to protect themselves. Mostly it involves research and critical thinking, especially when health and healthcare costs are concerned.

Rewards for Not Paying Attention

Should people be rewarded for not paying attention or for pretending they didn’t know about dangers that have been well publicized to the point that they are common knowledge? 

First, a less dire example of well-known information: a study hitting the Internet and the airways recently revealed that “Washing your hands under running water may be a better way to stop the spread of infections than using a hand sanitizer.” The hand sanitizer can be nearly as effective as washing hands for removing flu viruses, provided both are done properly. It just takes longer.

In laboratory experiments “it took about 30 seconds for the sanitizer to eliminate all the flu virus in the saline samples, but more than 4 minutes for the sanitizer to get rid of flu in the mucus samples.” From the lab tests they moved to a more real-life situation by putting mucus directly on people’s fingertips. When it was given time to dry (for 40 minutes), the hand sanitizer killed the flu virus within 30 seconds. But in a more realistic situation where the mucus was still moist, it took about 4 minutes of rubbing for the flu virus to be completely eliminated.

Proper hand washing removed traces of the virus in both cases in about 30 seconds, whether the participants used soap or not. The benefit is not from the soap, but from the rubbing under running water. 

No one is likely to rub the hand sanitizer for 4 minutes or alternatively to let their hands dry after sneezing for 40 minutes, but neither do many people spend half a minute scrubbing under running water. When a sink is not available the alcohol is a good option. 

That’s what we know today, but we had substantially the same information 10 years ago. From Live Science in October 2009: “Hand washing with ordinary soap and water is the most effective way to remove germs. But when you're on the go, alcohol-based hand sanitizers are tremendously effective in preventing the spread of the seasonal flu.” They gave 20 seconds for washing and 15 for the sanitizer, so the latest study just worked a little on the details. It wasn’t really news.

This is just one everyday example of how the media likes to present old news as some brand new revelation wrapped in the cloak of the latest study.

In light of that consider the opioid epidemic. Within the last two weeks, “OxyContin maker Purdue Pharma LP filed for bankruptcy protection…succumbing to pressure from more than 2,600 lawsuits alleging the company helped fuel the deadly U.S. opioid epidemic.” Nearly every state, numerous cities and counties and many others insist that the company “aggressively marketed prescription painkillers while misleading doctors and patients about their addiction and overdose risks.”

Any money awarded will not bring back even one of the 400,000 lives lost between 1999 and 2017, but the various levels of government hope to be able to confiscate money from drug company profits to remedy the situation rather than taking from tax payers.

My question is: what are they going to do with this money? Treatment is no doubt an option. Perhaps they will fund stocks of Naloxone (sometimes sold under the brand name Narcan). 

Of course, awareness will surely be part of the plan. But with the opioid epidemic in the news daily, with current Public Service Announcements and with the subject sure to come up in the upcoming presidential campaigns, what more can they do to get the word out? The company may have been playing fast and loose with the truth in the past, but now their website clearly states, “OXYCONTIN® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.” 

With so much information available, should compensation be available to everyone who becomes addicted from now on? At what point does society expect people to recognize and deal with the danger? In the case of cigarettes it has taken decades – people are still suing tobacco companies over risks that have been widely known for 50 years or more, but they claim to be victims. 

If risky or irresponsible behavior continues to be rewarded even well after the risks are known, problems will never be solved.

More Reason to Ban Drug Ads

The last time I wrote a “Don’t Ask Your Doctor” piece was almost three years ago. It was a follow up to the original in November 2012. 

It seems clear that the many drug ads on TV and in magazines with the punch line “Ask your doctor if [fill-in-the-blank drug] is right for you” are merely an attempt by pharmaceutical companies to bypass doctors to increase sales by appealing directly to Americans with a demonstrated weakness in the area of discipline. The companies try to use the patients to put additional pressure on their doctors to prescribe expensive medications. It often interferes with the doctors’ ability to make a proper decision for fear of getting into an unnecessary battle with or ultimately losing a patient.

A common example of this patient pressure that I have run across in the past is the number of people who have gotten antibiotics from their doctors to fight a cold. Antibiotics are not effective for a cold, because it is a viral infection, not bacterial. Doctors know this. It is a waste of money for the patient and a danger to the rest of us as it promotes the evolution of stronger, more drug-resistant viruses.

I am not alone in my objection to these ads. The Washington Times points out that “only doctors have the training about, and knowledge of, such drugs, as well as insight into their patients’ medical backgrounds that may or may not be appropriate for such medications” and that the ads “contribute more confusion than useful information.” The US and New Zealand are the only countries in the world to allow this practice.

The American Medical Association has been calling for a ban on those ads for many years. Their position “reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices.”

And those marketing costs are high! From 1997, when it was first allowed, to 2016 “spending on medical marketing of drugs, disease awareness, health services, and laboratory testing nearly doubled, going from $17.7 billion to $29.9 billion.” The direct-to-consumer portion increased the most, both in amount and proportion of spending from $2.1 billion (11.9% of total spending) in 1997 to $9.6 billion (32.0%),” while the amount spent in journals directed at the doctors decreased.  That spending adds to the cost.

This is doubly important today when we have such strong evidence of how easily patients, and in this case parents, are influenced by misinformation and make such foolish decisions, pressuring their doctors about vaccinations. 

Here is a subject where the science is clear, while warnings and side effects are not buried in the fine print. It’s simple; measles can kill. Vaccinations work.

In 2015, California passed a law eliminating personal belief exemptions for vaccinations that kids must receive before they can attend public school. They can only get a medical exemption from a doctor. Fearful parents are pressuring doctors, causing this medical exemption category to increase by 250% over the first two years of implementation. Some doctors are even cashing in on this unwarranted fear by charging $300 to $500 to write recurring exemptions. The understanding about measles prevention is clear, but there has been an outbreak on the West Coast (and in Europe). These falsified exemptions and parental beliefs endanger not only the kids with fearful parents, but those who cannot be vaccinated due to valid medical exemptions.

This single example casts doubt on the FDA’s original argument for TV ads, that giving consumers more information would lead to better outcomes. It has more likely led to more unnecessary prescriptions and higher drug costs.

Don’t Just Shrug

So often, especially on TV, a news story can go flashing by so fast that we hear the main point and don’t pay much attention to the rest and don't think too much about implications. Before we know it, they've moved on.

Last week the news came out with such a story, that the FDA has approved an exciting new cancer drug. According to an NBC report: “While several drugs are approved to treat a variety of different cancers based on genetic mutations, Vitrakvi, known generically as larotrectinib, is the first that is approved from the beginning to treat cancers solely based on the mutation.” Instead of being approved to treat specific cancers that arise in certain parts of the body, Vitrakvi goes after the genetic characteristic of a cancer arising anywhere in the body. Although it doesn’t work for all types of cancer, this appears to be a significant breakthrough.

But there is a huge downside. In the sub-headline NBC mentions that the wholesale cost is expected to be $393,000 a year.

Another website discussed the cost in a little more detail. “The wholesale cost for the children's syrup is $11,000 for a month's supply and the oral capsules for adults wholesales for $32,000 per month. With insurance, most patients would pay $20 or less for a 30-day supply.” (This last comment is the part that I think would blow past most people causing them either to shrug or to decide that the downside was minimal.) 

But it’s not, and it should make everyone slow down and ask where that money to pay the difference, that is, $31, 980 per month, is coming from. Initially it comes from the insurance companies, but ultimately it would come from premium payers, you and me - either directly or indirectly when employers count the benefit costs as part of total compensation.

Assuming that the estimate is correct and that this drug could benefit up to 3000 people a year, that’s $90 million a year that has to come from somewhere. And neither the insurance companies nor Bayer, the manufacturer, is going to foot the bill out of the goodness of their hearts. The cost will be distributed. Everyone must understand that this is true for all drugs that are covered in part by insurance. As newer, better and more expensive drugs are developed to treat or cure a wider variety of diseases, that same pattern is followed every time. This is basic economic understanding; there is no magic money tree.

This is the kind of information that slides by when we shrug it off without thinking it through.

Side comments: 

Is there any irony in the fact that the same company that makes this new cancer drug also makes RoundUp, a substance many people believe causes cancer and that some lawyers are now advertising about to solicit clients?

How would a member of the if-you-can’t-pronounce-it-don’t-eat-it crowd react if the cure to their cancer turned out to be larotrectinib? 

In other words, why clutter the courtroom and the dinner table with real science when you can rely on misinformation and Internet memes for guidance?

Only People Have Money

A key to economic understanding is the concept that only people have money.  Other entities pass around the money and may hold it for a while, but when you “follow the money,” as the expression goes, it always eventually comes back to individual wallets and bank accounts.

Thomas Piketty, a well-respected French economist, professor and author of several books on income inequality, made the point clearly in a 2009 essay.  He wrote, “Let’s also recall that no taxes are paid by businesses: ultimately, every euro of tax is always paid by households…there is unfortunately nobody except physical, flesh and blood people who can pay taxes.”

He goes on to say, “Inevitably, firms pass on everything they pay to their workers (by reducing their wages), or to their shareholders (by reducing dividends or accumulating less capital in their name) or to consumers (by raising prices).”  Higher (or lower) corporate taxes means one or more of these entities is going to be affected.

In fact, this economic principle is not limited to taxes.  Any action that affects every company in the US or all companies in a particular industry – whether it be regulations, union bargaining, tariffs, or external events such as weather – feeds back to the end consumer.  This is true because when a cost affects every company, it takes competition out of the equation.  In this case each company can pass along those costs directly without fear of falling behind.  

It works in both directions: companies pass along costs to the three categories of people but their revenue also comes from people.  After they make sales and pay expenses, they must decide how much of the difference to reinvest in the business, making shareholders happy; how much to lower the price, hoping to get more customers and grow the business; or how much to increase wages, hoping to attract and retain the best workers.

So when CBS reports, as they did early last month, that Apple, Amazon and Google made a load of money in the last quarter of 2017, we must understand that those billions came from our wallets. And no one forced anyone to buy an iPhone or order items on line.  Facebook had similar positive results, but they forced no one to log in or click on the ads.  All these companies got their money from individuals (households) by providing goods and services that they valued.  Unlike the case of corporate taxes where every company gets to pass along added costs, all these companies, and any other company that wants to stay in business, must compete every day to provide the best service or product at the best price. When they do, they attract customers. That’s where their money comes from.

Some politicians want you to hate the rich.  But, barring those who inherited their wealth, it was people who made them wealthy by willingly giving them money in return for something of value, either directly (Jeff Bezos at Amazon) or indirectly (Warren Buffett investing in successful companies).

This dynamic works very well unless the government gets involved.  When certain companies are favored due to their relationships rather than their ability to provide the best for the least, their incentive shifts from satisfying customers to influencing politicians.  They no longer compete for our business where we voluntarily trade our money for their products.  Instead they compete for money that was taken from us involuntarily by the government (in taxes) and paid out in grants and subsidies.  It’s easy to see how this can skew the system, replacing an emphasis on added value with efforts to influence politicians.  This shift ends up costing the entire economy in the long run as less efficient companies stay in business through government favors.

Economic understanding helps voters to step back and look objectively at some of the actions and promises of elected officials, sorting through fact and fiction by following the logical path to and from households – wallets and bank accounts.  As a current example, when all the cities and states sue drug companies over the opioid epidemic, the money they (and their lawyers) collect will ultimately be an indirect tax levied on households through higher drug prices just as tobacco lawsuits translated into higher cigarette prices.

Opioid Lawsuits

Recently states and cities, large and small, have made threats or begun the process of suing drug companies that manufacture opioids, blaming them for the epidemic of addiction and over-dose deaths that is sweeping the nation.

Here is a summary of one attorney general’s stance.  “Historically, opioid pain medications were considered too addictive and debilitating for anything but short-term acute pain and end-of-life care.”  But using sophisticated marketing campaigns in the 1990s, they “changed the prescribing culture, convincing doctors that opioids were not very addictive,” encouraging them to prescribe these drugs for chronic pain, using every trick at their disposal to increase sales.  They must take responsibility!

But the form of that responsibility is not specified.  The lawsuits reported on from cities in suburban Chicago “do not specify the amount of damages sought.”  So apparently their idea of responsibility means paying fines to governments.  A class action suit in West Virginia seems to be more focused and specific, seeking “relief for the following damages:

•  Medical expenses, including money (often thousands of dollars) spent on the prescription drugs in question
•  Costs for drug treatment programs
•  Lost wages
•  Pain and suffering
•  Funeral expenses (if they lost a loved one to overdose)
•  Any other relief the Court deems fair and just”

You would hope that such threat of penalties would motivate the drug companies to stop enticing doctors to do their dirty work.  These accusations certainly don’t cast a favorable light on the medical profession as a whole, but it’s probably like politics where everyone thinks their representative (or in this case doctor) is good, but the rest are despicable.

  

It reminds me of the lawsuits against Big-Tobacco, the primary difference being that tobacco has no redeeming characteristics, whereas opioids help people cope with severe pain.  Shutting tobacco companies down or at least fining them and requiring them to widely advertise the evils of their product makes sense, especially if it drives up the cost of cigarettes.  Driving up the cost of drugs or making them less available for the people who need them, on the other hand, would not be optimal.

Another problem arises from the fact that some of the people who became addicted and overdosed, did so using drugs that they obtained illegally.  Do we reward people for breaking the law by reimbursing them for lost wages, pain and suffering or money spent on their drugs?  That is for the courts to decide. 

Something to consider is how such a precedent may play out, suing companies that make a legal, beneficial product that can also be used irresponsibly or to break the law.  Some have already raised the idea of suing gun manufacturers.  Will cities move on to sue paint companies because they can’t control the spread of graffiti?  Will ladder makers be held accountable for the actions of cat burglars?  Why not sue glove companies or towel companies when no fingerprints are left behind at the scene of the crime?  Why didn’t this come up years ago when drivers were buying radar detectors for the sole purpose of warning them to slow down before they're caught speeding?  That was a product that, only with a great deal of subterfuge, could be represented as a benefit to society.  Lawsuits of this kind have already driven companies to plaster packaging and inserts with a host of, often ridiculous, warnings.

Some of those examples are farfetched, but the point is that states, cities and individuals seem to be surrendering, admitting the problem is beyond their control, their resources and their abilities, while looking for a scapegoat.  But isn’t this search for someone else to blame typical behavior of the addict they are trying to help and one of the first things they must overcome before recovery is possible?  Does no one else see the irony?

Whose Fault Is It?

There is an old story of a burglar falling through a skylight as he is attempting to ply his craft and suing either the skylight company or the owner of the building he is trying to break into.  Details are vague, and I could not find a reputable reference – at least not of that happening in the United States.

I did find cases of a burglar suing a homeowner in California for shooting back at him and wounding him after he broke into the house and one of a burglar suing a homeowner for shooting him as he tried to get away.  In another instance, the armed robber of a pizzeria thought he was owed about a quarter of a million dollars for being treated too roughly when he was arrested.

These all seem laughable, but how do we feel when a mayor sues a pharmaceutical company because his city has a problem with drug overdoses and the crime associated with the drug trade?  That’s what the mayor of Everett, WA is doing according to CBS News.  He “is suing Purdue Pharma, maker of the opioid pain medication OxyContin, in an unusual case that alleges the drugmaker knowingly allowed pills to be funneled into the black market.”  The lawsuit is an attempt to recoup some of the millions spent on added police patrols, social workers and permanent housing for chronically homeless people to combat the spread of OxyContin and heroin abuse in the city.

When we are young, it’s common to blame our faults or inadequacies on inanimate objects – I wore the wrong shoes or the sun got in my eyes.  A few years ago the blame for all psychological problems was put on our parents.  But you can’t sue the sun or your parents, though in the latter case some have tried.

Today the perfect solution is to blame a big, faceless company and sue them for damages.  Blame the iPhone for not having the technology to prevent people from texting and driving.  Blame the Jeep for rolling down a hill when the driver failed to set the emergency brake before getting out.  Blame home tanning beds for the rise in skin cancer.  Or blame the drugmaker for not preventing the drugs from ending up in the black market.  Then expect companies to warn all customers not to misuse the product – don’t take the phone in the bathtub while it is plugged into the wall to recharge.  Every time a customer misuses a product, the company faces a potential lawsuit and then we wonder why our economy is bogged down by regulations, our costs are higher than they should be and every package is littered with often ridiculous warnings.

I'm sorry the city has a drug problem.  But shifting part of the cost of enforcement from the taxpayers to the drugmaker, does nothing to solve the core, behavioral problem.  It just raises the price of pain medicine for those who desperately need it and have nothing at all to do with the problem.  This is the lack of responsibility.  Blame the drugmaker (and their legitimate customers), not the abusers or ineffective city policies.  Perhaps a good argument in favor of legalizing all drugs is to give the mayor the tools to identify and sue the makers of the heroin as well.