Less Price Relief From the Haven of Generic Drugs

High costs, in point of fact the highest cost of pharmaceuticals, have been a given for the resident of the United States. Citizen/health care consumers of these drug prices have pretty much accepted this state of affairs since the late 1980’s when under the Reagan administration, in anthromorphorzing view of the human-like actions of the big drug companies, upped their periscopes from the national headquarters bunkers, looked around at the regulatory landscapes, and saw the lack of regulation creating a manna from Heaven business opportunity for their business model and industry. And that was the realization that they could jack up prices even more and not get their knuckles rapped by the feds, or any of its past oversight, regulatory agencies.

And so, in my ‘industry, “healthcare,” [a term I and most providers hate unless they are more business types and less health care devotees in practice to make a decent living but mostly to serve their patients and ‘do good,]  became ‘business-ized at the upper, larger, company levels. Hospitals started buying up medical, surgical, and specialty practices at huge rates for the last 20 years. Providers found themselves being squeezed, pressured and commanded to evolve into a factory-like production model of seeing as many patients in as short an individual time as possible. Seeing patients does not lend itself easily to the Henry Ford conveyer belt mass production manufacturing model that has been the basis of modern production and business model that has dominated the industrial revolution since the early 1900’s. But the medicine behemoths have tried. And now they have reached the limits of that as patients and providers have typically 15 minutes or less for histories, physicals, treatment planning, execution and referral and whatever else is called from. Solo practices have disappeared as the economics of a single revenue generator cannot pay the overhead anymore, e.g., purchasing and maintaining a high-end mandated health information and record keeping system that is also used to monitor the quality of care issues and determine level of reimbursement for that poor shcmuch doctor living and practicing in the past. Groups have had to expand greatly, buy out other practices mirroring the wave of mergers in all industries who have had to adopt the same strategy to stay competitive for decades.

Now with limits of squeezing out more and more revenue of a system that cannot increase production beyond a certain limit, unless unscrupulous money making practices such as ordering procedures for larger numbers of patients that are not needed, medicine is turning to big data as its saviour to somehow point to population-wide ventures based on disease management through data that tells the data trend sifters and analysts what could need new attention and new ways of inventing new health care measure and generating reimbursements for preventive services to the ‘still well.’ Wellness program, weight loss programs, stop smoking campaigns, yoga classes, preventive back injury exercise programs (do you know any furniture movers or long distance truck drivers who need those, actually taking and paying for them? No, I didn’t think so.

The other rapacious and downright price gouging, darn near evil thrust of the mega-company sector of the ‘healthcare industry,’ {my definition of that is all the people who never see patients deal with only data, spreadsheets, costs analysis, ROI or return on investment, investing, selling, M&A [merger and acquisition], administration of healthcare entities usually at quite a geographic distance, since they oversee always more than one provider agency-hospital-clinic system], and therefore have lost all or almost all knowledge of patients, realities of illness, and the practice of medicine and nursing. Actors replace real healthcare figures portraying in tv commercials extolling these massive healthcare combines. The advertisements all sound alike, The Madison Avenue ad people have continues to lose sight of the reality that patients go to her where providers that they trust refer, not where the billboards tell them to go.

The pharmaceutical companies deal in research and patients, and marketing. The only regulatory body they have to deal with is the FDA. There are currently more noises and new efforts to reduce to oversight power of the FDA which may or may not be a good thing. The main initial proposals are along the lines of reducing the review and approval time. This may be good in helping to hasten the release of some drugs such as the orphan drugs, so called because they are intended for use with rare but usually devastating diseases that have little “market share,” since far fewer persons are afflicted with them compared to heart disease, diabetes, cancer, etc. Fewer medical consumers or those in need of such drugs, means, in reality, less potential for mass sales and therefore profits. But the last decade or more this arena has attracted far more deserved attention and such drugs are being developed, sometimes in drug companies’ consortiums, sharing the costs and making their ranks possible for those suffering from these past maladies for whom traditionally there was hope or help. This is of the many commendable new actions the Big and Smaller Pharma drug companies have taken. They have complied with making drug trial research data in trials more transparent by progressively posting on designated mandated Internet sites with the information visible to all interested co-researchers, competing research groups (horrors) and to interested CITIZENS. The drug companies somewhat resisted this concept but soon realized it saved them money as if they saw so and so research drug candidate was showing poor results in someone eles’s trials and was shaping up to be a flop, they could cut their losses early by halting its development or not committing to it at all.

But as the drug market has somewhat and I would predict temporarily “matured,” they have reacted by jacking up their prices again to new sociopathic, unconscionable highs. An example of the counter competition to the high priced branded Big Pharma model of drug pricing had long been the generic drug manufacturing industry. These companies bought the ‘leftover’ expired patents of former branded big sellers when their patients expired and in six months or more could develop, have reviewed by the FDA and market and price these generics at far more reasonable prices that reflected more closely their true manufacturing costs; these companies could still make a very good profit of possibly up  to 300% on a pill priced in the cents range and nobody would begrudge them such.

But things changed in the last several years when a new type of drug company leadership came into a few of the generic companies. They have replicated the familiar practices of hopefully somewhat defunct wild Wall Street finance companies who saw companies as pawns and overvalued them, went through wild mergers and acquisitions, and jacked up prices, inflated values, sold companies and the boom lasted for a while and started to burst sector by sector till 2008 and 2009 crises forcing Henry Paulson and President Bush to start the emergency bailout, and have to hand over the long term odious task to President Obama and by that time Great Recession was upon us.A long time generic drug maker, who although is itself reported to have had a badly checkered past of iffy business practices in times when it was a beacon of lower prices by basing its business notably on manufacturing and marketing large numbers of generic medicines at very helpful generic lower prices than the drugs commanded when they were high-priced branded medicines protected from competitor same formula meds until their patients expired

A long time generic drug maker, who although is itself reported to have had a badly checkered past of iffy business practices in times when it was a beacon of lower prices by basing its business notably on manufacturing and marketing large numbers of generic medicines at very helpful generic lower prices than the drugs commanded when they were high-priced branded medicines protected from competitor same formula meds until their patients expired.

What began to happen last year was very instructive and model of what was to come and has started to appear more and more to all of our detriment (detriments).

One company bought up the long generic medication of Epi-Pen. This was long out of patent protected status, and being reasonably priced. Now to jerk the heartstrings a little bit but I think in this case it is an entirely honest literary device. These are used in LIFE-SAVING situations, the child or adult in an acute life-threatening asthma attack not responding to their normal always carried rescue inhaler medications. Sometimes these frightening episodes could happen out away from hospitals in camping trips in a park, at a public entertainment event such as ball game, concert etc,. still a certain time away from life-saving measures. The Epi-Pen was, has been and still is, the personal, handy dandy life-saving self-administered rescue appliance.

This certain generic company overtook the patient seeing a golden opportunity prime for the pickings and raised the prices to a whopping $600 for a pair of pens, keeping the traditional name since it has such universal ‘name recognition.’ A national hue and cry resulted and one of the company bigwigs was hauled in front of Congress and grilled and growled at and I believe suffered some sort of company setback in his position. But a new CEO appeared on the scene and displays the kind of disregard and lack of empathy for the patient and consumer that is now attracting somewhat serendipitously attention based on brand new information released just last week or so on how absolute power tends to affect and attenuate the areas of the brain that help to activate empathy for others. In my mind this CEO personifies and this research (which I pledge to write about soon) serves to explain in a complementary way the research about narcissism that is endemic to the rich and powerful and so eloquently described in Christopher Lasch’s incomparable book, The Culture of Narcissism which I unhesitatingly regard as required reading in general. The now CEO of this company sees apparently nothing amiss in taking advantage of a drug that is a life and death drug needed by many. And it is an essential for the relatively rare true serious allergic reaction that can occur at any time in anyone whether from a routine drug to an esoteric new “biological” as drugs that work with the immune system in novel ways unheard of twenty years ago in psoriasis, rheumatoid arthritis, various forms of cancer etc. These reactions can quickly be life threatening, causing the mucous membranes of the lips, oral cavity, throat, and airway suddenly swell and drastically reduce the ability to inhale enough air to sustain vital functions including the brain itself. I myself had an early partial reaction like this to a medicine I had been on for months without incident and I had no reason to think or apprehend that this might happen, but happen it did and scared the bejeebers out of me. And my specialist physician called in to treat this apologetically prescribed the Epi-Pen and she and I both knew why she apologized ahead of time, because of its unGodly, unjustified extraordinary high price. But like most everyone else who could afford it or who good enough insurance to help, I obtained while wondering about the large number of persons in our “full of holes” health care system who could not so.

In psychiatry, we have seen the same phenomenon. Companies who produced certain valuable, still have their place, old time, tried and proven, past generation psychotropic medications, whether antipsychotics or antidepressants, have been swept up by generic combines, and consolidated down to one manufacturer who owns all the scattered generic licenses to produce the medication and then proceeded to multiply the past “generic” meaning low and reasonable, prices to new, neve seen before heights. Thorazine, for instance, the first antipsychotic medicine has fallen victim to this sea change in change in the meaning and utilization of patent branded-less status.

Thorazine is best known in its negative image from past decades when patients who were overmedicated for reasons of ignorance, when in its earliest years of use maximum dose ranges and guidelines were not a regular part of the FDA;s evaluation of medicine as its routine today, saw psychiatrists giving doses many times beyond the ranges that afforded maximum positive therapeutic effect. At those doses inflated and erroneous doses, the famous side effects of slowing of gait, shuffling [giving rise to famous descriptor: “the Thorazine shuffle’], motoric restlessness [formally known as “akathisia” and a very unpleasant subjective sensation], tremors, infrequent but extremely unpleasant acute muscle cramps) all made Thorazine the bad poster boy for antipsychotic and served as a rallying cry by protest  groups dedicated as antipsychiatry groups. But Thorazine has survived and has had an enduring good use in calming agitated patients better than the Valium-like benzodiazepine medications that are known to be potentially dependency-producing, disinhibiting, and even addictive with prolonged use. Thorazine does none of those bugaboos. It is best used in LOW doses, 25mg to 100mg for calming and safely so as side effects are rare at those levels. It is even utilized in acutely agitated, assaultive teens, one of the most hazardous populations to work with in any psychiatric setting when seriously agitated.

Thorazine’s unfortunately caught the entrepreneurial profit oriented eye of a generic company and had its various companies’ rights bought up and then was “rebranded” and submitted to the FDA as a “virtual” new medicine [emphasis mine in  this age of virtual this and that disguising or substituting a new reality as I understand the current new use of the word; another example, my oncologist and I call my long medical oncologic maintenance medication recipe keeping my myeloma at bay, a “virtual permanent remission,” a term I find somewhat reassuring as a cancer patient also novel and new age HILARIOUS as a technical euphemism and quote it all the time in arcane jokes..].

Thoazine’s former pricing as a generic drug in the old circumstances was cheap, tablets being in the range again cents, from say I guess 15-25 cents or so, to slightly higher for higher dose tablets. Now in its ‘new life’ n the race horse remuda collection of new overpriced bandit generics, it costs at a minimum per tablet in the near THREE DOLLAR range for a low dosage tablet!!!

And it is not talked about much outside mental health circles as still the public discourse of our matters and issues is still difficult for the public and the media and the legislative worlds. But it is a serious issue with a very significant impact on cost issues.

It is bad enough that new antipsychotic such as Vraylar, new to the market in the last year or slightly more, not yet widely utilized or know and which may have a valuable niche, adjunctive role in psychiatry, repeats the 30 year old practice of new medications to the market costing incredible amounts of monies until their 15-20 year branded patent status expire. Last week I personally checked the WalMart average price of Vraylar per month for the average consumer and it was $1137 a month!!! I thought to myself, “Gee it this stuff made one high in any way, one could sell it on the streets! Absurd, but then again the price is absurd.

American drug companies will partially correctly offer the rationale that the development prices are huge, and they ARE. It takes by common knowledge a minimum of $500M to bring a drug to market. Most drugs flunk out and never make to market and end up in the labs’ virtual dumpsters of failure. But all other Western countries and many Third World countries have far lower drug prices for the same medicines. And many drug companies have high percentages of their total physical, research and administrative offices and presences overseas. More and more drugs are developed through drug companies partnerships and sharing of development costs. More and more drug companies are foreign entities altogether, e.g. Boerginers, Elan in Israel, Osaka and many others in Japan and the list can go on impressively

But still our drug prices are extraordinarily high and it is commonly held that American consumers pay the bulk of the drug development costs. We do the heavy lifting economically seemingly for the rest of the patient consumer world. Is that entirely fair? That is an issue that needs long, thoroughgoing review and repair at the highest levels of our government, almost in a setting akin to the status of the Special Prosecutor, FREE of any and all lobbying and influence peddling and money greasing palms of those who would fashion the new more fair and revolution in the workings of the drug development national environment in our country that preserve the ability of the drug companies to receive a fair but not pirated return on their work and huge investments, and benefits the little guy and gal, the patients who cannot mobilize the kinds of corporate pressure that the big entities can at the writing of a check of influence drawing on their vast cash “reserves,” that the citizens’ advocacy groups can never match.

It is beyond time for fair change. I shudder to imagine what could happen to visible symbols or corporate greed in this day and age of increasing violence borne of hopeless cynicism where rash action appears to be the only alternative. Our social and governmental organs of our democratic society must start working on real issues instead of the utter nonsense we have seen recently.

 

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