DRUG PRICES: WHY ARE THEY SO HIGH AND CAN WE DO ANYTHING ABOUT IT?

drug prices

    America spends a tremendous amount for prescription drugs—$424 billion last year alone. And that number is rising fast with no sign of slowing down anytime soon. We often encounter horror stories of drug companies that decide to raise prices to astronomical levels, and we wonder why they get away with such reprehensible behavior. The answer is, sadly, because they can!

We have long known that when new drugs are patented, the originating company gains the exclusive right to be a de facto monopoly for the life of the patent, ordinarily 17 years. After that, competition is allowed to enter and, in theory, provide generic versions, which should cause the prices to drop considerably. But now we are witnessing a significant increase in both new and some older drugs as well.

Let’s look at some reasons for such high prices:

Reason 1): Drug companies can charge whatever price they want. There is simply no regulatory source, government or otherwise, that has the power to control drug pricing. When asked why they are charging apparently exorbitant prices, they often respond by claiming they are recouping very high costs for research and testing. This is partially true, but, for large companies such as Pfizer, approximately 16% of their revenue is devoted to research, whereas they spend about 30% on selling, marketing, and advertising expenses. Moreover, taxpayers already shoulder a substantial portion of those research costs. About 38% of all basic science research is paid for with tax money through federal and state governments, according to a recent study published in the AMA journal.

There is also no restraint on companies’ raising prices on already marketed drugs that continue under patent protection.  For instance, in the past year or so, Abilify, given for bipolar disorder and other mental problems, increased over 10% to approximately $1,000 per average monthly prescription.

Reason 2): Insurance companies are charging you more. In theory, these companies should be protecting you against high prices, but instead, they have been passing on the elevated prices through raising your co-pay or deductible amounts, or simply raising your premiums, all of which, in effect, pass on much of the high costs directly to the consumers.

Reason 3): Old drugs are being reformulated as costly “new” drugs. One example is that of insulin, a drug that is over 100 years old. But companies repeatedly change its formulation, allowing them to get new patents each time. For instance, one new form of insulin is called Toujeo, given by an injection that lasts for about 1 week. Each dose of 450 units may cost about $350, and depending upon how much one requires, can amount to tidy sums for the company.

Reason 4: Generic drug shortages can trigger massive price increases. For various reasons, shortages of basic ingredients of generic drugs can arise and lead to price gouging. One example is that of the old drug, colchicine, commonly used for the treatment of gout, a form of arthritis. In past years this drug could be purchased for mere pennies, but now, it retails for approximately $8 per pill, and often as many as 8-10 pills or more can be necessary for a single attack. A daily dose of one pill or more may also be needed on an extended basis.

Reason 5): “Specialty” drugs can be “out of sight”. The rise of super-expensive, so-called specialty drugs is a real threat. For example, the hepatitis C medications, Sovaldi and Harvoni, can cost up to $95,000 for a single 12 week course of treatment.

At present, according to a recent report by the Congressional Research Service, these drugs account for less than 1% of prescriptions in the U.S. but represent about one-third of total drug spending by consumers. Since drug companies push heavily in the direction of such highly profitable products, it is likely that by 2020 very expensive drugs will constitute an even bigger chunk of drug spending.

More than half of the 56 medications approved by the FDA in 2015 were of this specialty variety, and more than 900 biologic drugs are currently under development. While these products offer great hope for the future, this raises the important question of how society is going to afford them.

Compounding this problem, competition in this specialty arena may not eventually bring down prices as one would usually expect, for many such drugs are biologics—medications derived from living microorganisms. That makes them much more difficult to copy than conventional drugs, meaning that cheaper generics are far more difficult to produce in a reasonable period of time.

HOW CAN WE DEAL WITH THIS PROBLEM?

The drug companies should be encouraged to adopt a more humane policy, which would involve controlling prices at a more reasonable level, certainly in line with overall inflation. But at least they should be forced by the public to justify apparently unreasonable prices. For instance, Vermont passed a bill that requires these companies to justify high costs and price increases, and to calculate the financial effect on insurance premiums with many specified drugs. This measure at least raises public awareness and provides misbehaving companies with bad PR, something that should get their (and their stockholders’) attention. In most foreign countries, governmental intervention causes prices for the same drugs to be considerably less than in the U.S. For instance, in the U.K., a centralized advisory board calculates the value of a medication by taking into account a drug’s efficacy, safety, and total benefits to the healthcare system. As a result the price of the same drugs in that country averages about 50% less then here. Although reasons vary from country to country, prices in the U.S. are far greater than all the other western nations.

Our government should do more to curb these prices, and could accomplish this through the following means: First they could set a limit on out-of-pocket costs, providing protection against very high or sudden spikes in prices. For instance, California enacted a law limiting a consumer’s burden at $250 for a single prescription drug per month, or $500 for certain high-deductible plans. Second, they could more rapidly approve more generic versions of common drugs, currently a slow process. Third, they could allow limited importation of drugs from legitimate Canadian and European sources, which is currently illegal under U.S. law. Fourth, they could use their so called “march in” rights, that is, in cases of high prices of drugs developed in part from taxpayer money, the Department of Health and Human Services could force the company to allow another manufacturer to make a generic version that is cheaper for the consumer. Finally, the government should prohibit direct to consumer advertising of prescription drugs; other than New Zealand, we are the only nation that allows such promotion.

Perhaps the most potent means to control excessive pricing is through the enactment of a single payer system in the U.S., i.e. Medicare for all, which I have discussed before, http://www.mortontavel.com/2015/12/31/. This would allow the government to negotiate directly from a position of power with all pharmaceutical companies. This provides another good reason—of many—to move to the single payer format. Some have estimated that such an intervention could reduce drug prices by about 40%.

Finally, the consumer can fight back on a personal level. Ask your physician, before he or she writes a prescription, what the expected costs are likely to be, and if there are equivalent cheaper generics available. Although you could mention a given drug advertised on TV, do not insist that you receive it unless this is agreed upon by your own doctor. Also, there are many instances of older drugs, while not identical to the newer patented variety, are just as effective and far less expensive.

In all instances, consider shopping around for the lowest prices, which includes online sources such as GoodRx to learn a drug’s “fair price.” Prescriptions can be filled by legitimate sources such as HealthWarehouse.com. Be careful, however, since fraudulent sites abound, use only those operating within the U.S. and display the VIPPS symbol to show that it’s a Verified Internet Pharmacy Practice Site.

Unfortunately, the ultimate answer may lie with our government, which has to power to restrict such excesses, while, at the same time, must avoid stifling necessary research. This is a daunting task, but for those that believe that government should stay away from this problem altogether, be ready to suffer the consequences!

 

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Aren’t all mass shooters mentally ill?

gun and insanity

Here is what LIZA H. GOLD, MD, clinical professor of psychiatry at Georgetown University and contributing writer to the book “Gun Violence and Mental Illness” American Psychiatric Association Publishing, 2016, had to say in answer to this question..

On June 12, 2016, a man walked into an Orlando, Fla., nightclub and committed the worst mass shooting in U.S. history. When it was over, 49 people lay dead and more than 50 others were wounded. The shooter must have been mentally ill. Only someone with a serious mental illness would commit such a horrible crime, right?

Wrong! Evidence indicating that the perpetrator’s motives lay in his political/religious ideology and possible homophobia quickly knocked mental illness out of the debate about motivation behind this particular shooting. Nevertheless, media speculation about mental illness invariably accompanies mass shootings.

Mass shootings are the most sensational, gut wrenching, and widely publicized form of firearm violence. Nevertheless, statistically speaking, mass shooting homicides are the rarest form of firearm death. These incidents account for less than 1% of firearm mortality each year. About 33,000 people a year are killed by firearms. Firearm suicide accounts for about 65% of these deaths; the rest are overwhelmingly the result of interpersonal violence, not violence committed by a stranger with a gun.

All of us recognize the images of mass shooters who were in fact mentally ill, such as the young man with the dazed look and red hair in Aurora, Colo., and the chilling images of the Virginia Tech shooter posing with his weapons. Individuals in the first throes of psychotic illness are at increased risk of committing some type of violence as their functioning deteriorates, their thoughts become more disordered, and their lack of insight often leads to treatment refusal.

However, most mass shooters are not suffering from serious mental illness. As has been discussed in a recent article, mass shooters often hold “extreme overvalued ideas,” that is, nondelusional, strongly held beliefs, a concept that does not fit neatly into psychiatric diagnostic categories. As Dr. Tahir Rahman, an assistant professor of psychiatry at the University of Missouri, Columbia, and his colleagues wrote in a recent study: “An extreme overvalued belief is one that is shared by others in a person’s cultural, religious, or subcultural group. The belief is often relished, amplified, and defended by the possessor of the belief and should be differentiated from a delusion or obsession. The idea fulminates in the mind of the individual, growing ever more dominant over time, more refined, and more resistant to challenge. The individual has an intense emotional commitment to the belief and may carry out violent behavior in its service. It is usually associated with an abnormal personality.”. We used to refer to people who hold such beliefs as “fanatics.”

The line between psychotic delusions and extreme overvalued ideas is not always clear, but some markers and signposts can differentiate between the two. Psychiatric illness is suggested, for example, by the presence of other recognizable symptoms of mental illness, such as other delusions, hallucinations, or thought disorders. In addition, individuals with psychiatric illness demonstrate related functional impairment preceding and unrelated to the mass shooting. Finally, delusions are rarely shared by even two individuals; they are not shared by large groups.

Examples in which large groups of people share social, religious, or political beliefs and some believers resort to violence can be found throughout history: from Masada to 19th century abolitionists such as John Brown to 20th century animal rights activists and 21st century “sovereign citizens.” Finding groups that reinforce and validate extreme beliefs has become even easier in the age of social media.

However, fanatics often function adequately in society until something happens to trigger a choice to act violently. Absent a history of felonious violence, these individuals are not likely to be barred from owning firearms. More non–evidence based firearm ownership restrictions for those with mental illness are not likely to slow down or decrease the rising rate of mass shootings.

We do not have more people with psychosis in the United States nor do we have more people who hold extremist ideology. What we do have are more legally purchased, military-grade weapons in the hands of a civilian population than any other comparable country. An overwhelming number of mass shootings involve assault weapons.

One popular definition of insanity is doing the same thing over and over again and expecting different results. Only one intervention could make a difference in the increasing number of heartbreaking mass shootings. Military-grade semiautomatic weapons and their high-capacity magazines should not be available to civilians with or without mental illness or fanaticism. Moreover, as the Newtown, Conn., families are doing in their lawsuit against Remington Arms, the manufacturers who sell and market such weapons to civilians must be held legally accountable for valuing their profits over our lives.

So the next time you hear another politician harp on more vigorous control of mental illness as a means control gun violence, consider what the mental experts have to say on this subject, and vote accordingly!

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GMO UPDATE: WHEN “DO GOODERS” CAN BE “DO BADDERS”

       Cereal GMO         As I reported previously, (http://www.mortontavel.com/2013/06/21/) there is danger in labeling plants and foods as “genetically modified.” (GMO). Sadly, organizations with titles that sound helpful, such as Greenpeace, Consumer’s Union, Organic Consumers Association, etc., are actually pandering to irrational fears, to the detriment of a world that will, in the future, be desperately in need of adequate food supplies. They are urging governmental mandates to label all such foods as specifically modified in this fashion. In order to set the record straight, many distinguished scientists have come out with a powerful statement:

Nobel Laureates blast Greenpeace’s anti-GMO activities:.

More than 100 Nobel Prize winners have signed an open letter to promote the use of genetically modified plants and reject the views of its opponents. The letter states:

  • Global production of food, feed, and fiber is expected to have to double by 2050 to meet the demands of a growing global population.
  • Scientific and regulatory agencies around the world have repeatedly and consistently found crops and foods improved through biotechnology to be as safe as, if not safer than those derived from any other method of production.
  • Despite this, organizations opposed to modern plant breeding, with Greenpeace at their lead, have opposed biotechnological innovations in agriculture; misrepresented their risks benefits, and impacts; and supported the criminal destruction of approved field trials and research projects.
  • Greenpeace has led the opposition to Golden Rice, which has the potential to reduce or eliminate much of the death and disease caused by vitamin A deficiency (VAD), which causes 1 to 2 million preventable deaths each year, mainly among the poorest people in Africa and Southeast Asia.
  • VAD is the leading cause of childhood blindness globally affecting 250,000 to 500,000 children each year, half of whom die within 12 months of losing their eyesight.

The signers urge Greenpeace and its supporters to recognize the findings of scientific bodies and regulatory agencies and abandon their campaign against “GMOs” in general and Golden Rice in particular. They also urge governments of the world to oppose Greenpeace’s actions and accelerate farmers’ access to all the tools of modern biology, especially seeds improved through biotechnology. The Support Precision Agriculture Web site lists the laureates and more than 2,500 others who have joined the campaign so far.

The current move by several states to mandate labeling of all foods modified in this way sends a misleading message to the public, suggesting that these foods are somehow “tainted” or less safe. Nothing could be further from the truth!

    I, for one, wholly endorse the scientists’ initiative!

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Science Weighs In on High Heels

shoes

Obviously, what we wear on our feet affects how our bodies move. People who run barefoot, for instance, are more likely to land near the front of the foot with each stride than people wearing typical running shoes, who more commonly land on their heels.

But few other shoes affect the shape and functioning of the foot as dramatically as high heels do. According to a recent review of the available research about footwear, walking in high heels can alter the natural position of the foot-ankle complex, and thereby produce a chain reaction of effects that travel up the lower limb at least as far as the spine.

But while it’s clear that the feet and ankles of women who wear such heels over a long period of time are different from those of women who usually wear flats, the progression of theses changes has not been well understood.

A recent study published in The International Journal of Clinical Practice, researchers in South Korea turned to a handy recruit group: young women at the university studying to become airline attendants who were required to wear high heels to class, since they would have to wear them if hired by a Korean airline. With each passing year, from incoming freshmen to seniors, the women would have one additional year of heel wearing behind them, making it easy to track physiological changes.

The results were interesting. Compared with the freshmen, who were generally new to wearing heels, the sophomores and juniors displayed greater strength in some of the muscles around their ankles, particularly those on the inside and outside of the joint. Although this difference between new and experienced heel wearers suggested that wearing high heeled shoes may at first lead to adaptation and increased strength, the senior women, who had been wearing heels the longest, showed weakening of those same muscles, compared even with the freshmen, as well as much weaker muscles along the front and back of the ankle, resulting in dramatically worse balance. In fact, all of the upperclasswomen had worse balance than the freshmen, even as some of their muscles were strengthening. What appeared to have been happening is that the ratio of strength between the muscles on the sides of the ankles and those at the front and back became increasingly unbalanced over years of wearing heels, contributing to ankle instability and balance problems and eventually to a decline in the strength even of those muscles that had been stronger for awhile.

This finding is worrisome because strength imbalances in the muscles around a joint, especially those around the ankle, are known to increase injury risk in other muscle groups, such as those in the hamstrings or upper leg.

So should women give up wearing high-heels altogether? If it’s possible, I would respond with an emphatic yes! However, if such shoes are unavoidable, wearing should be minimized as much as possible. Moreover, people who often must wear high heels should strengthen their ankles whenever possible with simple heel lifts, where one stands barefoot and then rises onto the toes repeatedly; and heel drops, during which one stands on the edge of a stair, slowly lowering the heels over the edge.

Whenever possible, slipping off heels while sitting at one’s desk should be done, since wearing the shoes, even when not moving can alter the resting length of the muscles and tendons around the ankle, which could destabilize the joint and increase the risk of injury.

Also never run purposely in heels. The impact forces created are concentrated over a small region of the foot in high heels, creating regions of very high pressure, often resulting in foot pain. Additionally, balance and biomechanics are compromised, making running in heels a very inefficient way to move.

In conclusion, whoever invented high heels should themselves be required to wear them 24-7; perhaps then they would learn to be careful of what they had wished for!

 

 

 

 

 

 

 

 

 

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