{"id":116,"date":"2003-06-01T11:00:00","date_gmt":"2003-06-01T11:00:00","guid":{"rendered":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/?p=116"},"modified":"2021-12-08T14:05:13","modified_gmt":"2021-12-08T14:05:13","slug":"part-16-theres-a-generic-in-my-shark-fin-soup","status":"publish","type":"post","link":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/2003\/06\/01\/part-16-theres-a-generic-in-my-shark-fin-soup\/","title":{"rendered":"Part 16: There&#8217;s a Generic in my Shark Fin Soup!"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"450\" height=\"415\" src=\"https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/wizardsofmoney.jpg\" alt=\"\" class=\"wp-image-8\" srcset=\"https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/wizardsofmoney.jpg 450w, https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/wizardsofmoney-300x277.jpg 300w\" sizes=\"auto, (max-width: 450px) 100vw, 450px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><\/h3>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"alignright size-full is-resized\"><a href=\"https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2003\/06\/16-Theres_a_Generic_in_my_Sharkfin_Soup.mp3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/Svengraph_Headphones.png\" alt=\"podcast 16\" class=\"wp-image-35\" width=\"128\" height=\"128\" srcset=\"https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/Svengraph_Headphones.png 512w, https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/Svengraph_Headphones-300x300.png 300w, https:\/\/earlywithdrawal.net\/wizardsofmoney\/wp-content\/uploads\/2021\/12\/Svengraph_Headphones-150x150.png 150w\" sizes=\"auto, (max-width: 128px) 100vw, 128px\" \/><\/a><figcaption>16<\/figcaption><\/figure><\/div>\n\n\n\n<p>This is the Wizards of Money, your money and financial management series, \nbut with a twist. My name is Smithy and I&#8217;m a wizard watcher in the Land \nof Oz. This is part 16 of the Wizards of Money series and it is entitled \n&#8220;There&#8217;s a Generic in my Shark Fin Soup!&#8221;\n<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><b><a name=\"Intro\"><\/a>Introduction<\/b> <\/h3>\n\n\n\n<p>In this, the sixteenth episode of the Wizards of Money, we&#8217;re going \nto take a look at the world of drugs &#8211; the legal ones, that is. The star \nof this episode is the only industry more profitable than the commercial \nbanking sector throughout the 1990s &#8211; and that&#8217;s the pharmaceutical industry, \nof course.\n<\/p>\n\n\n\n<p>We&#8217;ll start with a look at the recent wave of pharmaceutical mega-mergers \nand what&#8217;s driving them \u2026 from the ominous &#8220;Shark Fin Curve&#8221;, to the search \nfor the elusive &#8220;Blockbuster Drug&#8221;, to the need for ever more shelf space. \nThen we&#8217;ll look at the battles between the brand name drug companies and \nthe generic companies, governments, and the other big giants of healthcare \n&#8211; the managed-care companies.\n<\/p>\n\n\n\n<p>This journey through the shark-infested world of &#8220;legal drugs&#8221; will \ngive us a good look at the bizarre human behavior that results from allowing \nthe capital markets and the patented medicine model to dominate decision-making \nin one of the oldest of human pursuits\u2026finding remedies for human illness. \nAllowing this behavior to continue unfettered may very well end in the \ncapital markets giving themselves an incurable disease. For, while the \ncapital that flows into drug research and development is obsessed with \na couple of shark fins on the horizon, it is failing to notice the tidal \nwave swelling just over the horizon. This tidal wave is the global HIV\/AIDS \ncrisis, already striking at the very thing the capital markets need to \nsurvive.\n<\/p>\n\n\n\n<p>Far away, in the land where Shark-Fin soup is a high-priced legacy of \nImperial times, HIV\/AIDS is rearing its ugly head. As the epidemic rips \nin to China, will the US be able to continue its token level support for \nthis crisis of the developing world? Or will this threat to the labor force \nof a major trading partner provide the shock necessary to remind us that \nillness prevention and cure is, after all, a social service that does not \nfit well into the confines of 20-year patent monopolies. And will the exponential \ngrowth of HIV\/AIDS in Eastern Europe and the former Soviet states, right \non the doorstep of the European Union, wake up the rest of the West to \nthe need to either act now, or risk losing their global marketplace?\n<\/p>\n\n\n\n<p>Let&#8217;s get started with a discussion of what&#8217;s been going on in the world \nof patented drug monopolies.\n<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><b>Predator-Prey Dynamics in the Drug Sea<\/b> <\/h3>\n\n\n\n<p>A July 16, 2002 article in &#8220;The Economist&#8221; announced the union of the \ntwo drug giants Pfizer and Pharmacia by opening &#8220;Depressed, bald-headed \nmen with erectile dysfunction should be especially pleased.&#8221; The companies \nthat make the world&#8217;s leading treatments for baldness, depression and Mothers \nNature&#8217;s way of telling gentlemen their reproductive years are over, have \ncombined to become the world&#8217;s biggest legal drug giant. The Pfizer-Pharmacia \ncombo boasts over $50 billion in annual drug sales and spends about $7 \nbillion a year on Drug R&amp;D (Research and Development), plus another \n$3 &#8211; 4 billion on drug advertising.\n<\/p>\n\n\n\n<p>As in most industries, the capital markets drive the classic predator-prey \ndynamics of the pharmaceutical sector. You either eat\u2026Or you get eaten!\n<\/p>\n\n\n\n<p>The Pfizer digestion of the smaller Pharmacia, announced in July 2002, \nwas just the latest episode in the struggle to the top of the food chain. \nLet&#8217;s go back to 1995 when much of the mega-merger madness was just heating \nup. In that year, Glaxo Holdings gobbled up Wellcome Plc to form Glaxo-Wellcome. \nThe following year the Swiss drug giant Novartis was formed out of the \nmerger of Ciba-Geigy and Sandoz. 1998 saw the creation of Aventis out of \nthe fusion of smaller drug companies and AstraZeneca from Astra and Zenenca. \nAbout a year later Pharmacia &amp; Upjohn thought Monsanto looked pretty \ntasty, so they swallowed them whole, only to spit out the controversial \nagribusiness piece in August of this year. Also in 1999 we saw Pfizer swallow \nWarner-Lambert. Glaxo-Wellcome and Smith-Kline-Beecham were fused together \nto form GlaxoSmithKline in 2000. And just when we thought the mergers couldn&#8217;t \nget any bigger &#8211; Pfizer and Pharmacia announced their merger, pending regulatory \napproval, in July 2002 to outsize GlaxoSmithKline, and become the biggest \nfish in the drug sea.\n<\/p>\n\n\n\n<p>And there are rumors of yet more drug mergers on the horizon!\n<\/p>\n\n\n\n<p>The modern pharmaceutical industry has its origins in the late 1800s \nwhen it became possible to mass-produce compounds such as morphine and \ncocaine. By the early twentieth century drugs and compounds were patented \nby various companies to protect their discoveries. A patent on a branded \ndrug or chemical gives the company a monopoly on sales of that chemical \nfor a specified period, enabling them to set high prices in the absence \nof competition. The argument for patent protection is that it enables the \ndeveloper to recover their investment in R&amp;D plus a profit, hence providing \nincentive to private industry to find new cures. However, in order for \nthe company to lure customers into buying such a high priced product they \nalso need to spend a lot of money on advertising and marketing to convince \npeople that it\u2019s a very special product. There are many arguments both \nfor and against the patent model for pharmaceutical development and we \nshall revisit these later.\n<\/p>\n\n\n\n<p>Today, the brand name drug companies look nothing like their chemical \ncommodity predecessors of the 1800s. New products require large investments \nin R&amp;D and take a long time to bring to market. The drug giants are \ndependent on patents, marketing and branding to make a profit. Consequently, \nthe pharmaceutical sector has more in common with the Hollywood movie industry \nthan with any public service provider &#8211; A new drug must become a profitable \n&#8220;Blockbuster&#8221;, or it&#8217;s not worth the effort to develop it.\n<\/p>\n\n\n\n<p>In contrast, generic drug companies spend comparatively little on R&amp;D \nand advertising, existing primarily to compete for market share based on \nprice once a patent on a brand name drug has expired. Once such a patent \nexpires, generic companies can copy the drug and can afford to sell it \nat a lower price (as low as a quarter of the branded drug price) since \nthey don&#8217;t have as much R&amp;D and advertising costs to recoup.\n<\/p>\n\n\n\n<p>After roaring successes and record high profit levels throughout the \n1990s, today we find that all is not well in the world of blockbuster remedies. \nAilments in the branded pharmaceutical sector include looming patent expiries \nand the resulting competition from generic companies, a drug R&amp;D pipeline \nthat is drying up, and angry governments, corporations, consumers and managed-care \ncompanies tired of high drug prices.\n<\/p>\n\n\n\n<p>These common enemies are forcing all these unions amongst the drug giants \nwho hope that consolidation will allow them to do more of their two favorite \nthings at lower cost. These two things are (1) Advertise and (2) Produce \nBlockbusters. The future dangers to the general public of all this industry \nconsolidation, in terms of even higher drug prices and, more seriously, \nthe lowered ability of the pharmaceutical sector to respond to real illness, \nare not getting much attention. The latter is reflected not only in the \nuntreated epidemics haunting the developing world, but even here in the \nUS, with increasing reports of shortages of basic medicines and vaccines \nat many hospitals.\n<\/p>\n\n\n\n<p>These problems are all compounded by the fact that drug companies are \nfighting dirtier and dirtier to counter the &#8216;Attack of the Generics&#8217;.\n<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><b>Attack of the Generics! Meet the Shark  Fin Curve.<\/b> <\/h3>\n\n\n\n<p>A story in the Wall Street Journal in June of this year about the birth \nof the much touted heartburn drug Nexium gave many people their first good \nlook at the importance of the &#8220;Shark Fin Curve&#8221; haunting the pharmaceutical \nindustry. You must know the Nexium ads, with a bunch of middle aged folks \nstanding around in some canyons that presumably represent an eroded esophagus, \nall mumbling &#8220;I didn&#8217;t know, I didn&#8217;t know, I didn&#8217;t know&#8221;.\n<\/p>\n\n\n\n<p><i>Insert: Nexium Ad<\/i>\n<\/p>\n\n\n\n<p>Well, I bet they didn&#8217;t know this\u2026The only reason Nexium exists is that \nits predecessor, Prilosec, which is almost exactly the same &#8211; is coming \noff patent. It&#8217;s sliding right down the other side of the Shark Fin Curve. \nThis eroded esophagus business is all about making the new patented drug \nNexium seem different to the one that will now be copied by the generics.\n<\/p>\n\n\n\n<p>The Wall Street Journal article describes the Shark Fin Curve as the \nSales versus Time graph of a patented drug. It looks like an upside-down \n&#8220;V&#8221;. As soon as a patented drug is launched, revenues generated by it shoot \nup over time like the rising edge of a shark fin. But the minute it comes \noff patent they plunge just as quickly as they rose, as the generic companies \ncome in, copy the drug, steel market share and force prices to drop. We&#8217;ll \ntalk more about Shark Fins and eroded esophagi later when we look at some \ncase studies of how the big drug companies fight back against generic competition.\n<\/p>\n\n\n\n<p>During the roaring 90s the pharmaceutical industry always seemed to \nbe topping the charts as the most profitable. We are all familiar with \nthe Blockbuster Drugs who made this dream a reality and have become celebrities \nin their own right &#8211; there&#8217;s Viagra, Vioxx, Celebrex, Claritin, Nexium, \nPrilosec, Lipitor, Rogaine, Zocor, Zoloft, Prozac, Paxil and Lamisil &#8211; \nto name but a few. Some will be on patent for many more years but others \nare soon scheduled to come off patent. Many patented drugs are simply &#8216;me-too&#8217; \ndrugs, designed to achieve the same effect as other patented drugs, but \nreally add little value to society as a whole. To overcome lost revenues \nfrom patent expiries and the me-too drugs, each drug giant needs a certain \nnumber of new blockbuster drugs emerging from the R&amp;D pipeline every \nyear. Massive advertising campaigns are then designed to sell enough of \nthe drug at a high enough price to recoup the R&amp;D and advertising costs \nplus a target profit level.\n<\/p>\n\n\n\n<p>But the big pharmaceuticals, much to their dismay, are finding that \nthe blockbuster drug cabinet is bare, even after throwing piles of dough \ninto the R&amp;D bucket. Despite the extensive range of the silliness of \nthe illnesses for which blockbusters can be made to remedy, such as toenail \nfungus and hair shortfalls, big pharma is still finding that it can&#8217;t find \nenough new drugs to bring to market. This makes them more desperate to \nmaintain high revenues on existing patented products, so they pour more \nand more funds into advertising and into fighting the generic companies \nin court.\n<\/p>\n\n\n\n<p>End Result: Profits are down in the pharmaceutical industry and the \nnear future looks glum. And we get to see even more drug ads!\n<\/p>\n\n\n\n<p>Add to all this the following pressures on the drug giants:\n<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\nEuropean governments dare to regulate prices of their precious Blockbusters,<\/li><li>\nUS State Governments are now cracking down on some of Big Pharma&#8217;s desperate \npractices to shut out the generics,<\/li><li>\nDrug companies get pressure from managed-care companies to lower prices,<\/li><li>\nDrug companies now face a whole new set of giants &#8211; a coalition of corporate \ngiants called &#8220;Business for Affordable Medicine&#8221; &#8211; whose healthcare expenses \nhave been shooting up with the cost of prescription drugs. This coalition \nincludes such behemoths as General Motors and Wal-mart (for example General \nMotors pays over $50 million a year just to buy the heartburn drug Prilosec \nfor its employees and they are not happy).<\/li><\/ul>\n\n\n\n<p>It looks like the drug companies, poor things, could use a dose of their \nown anti-depressants!<\/p>\n\n\n\n<p>True to form, however, the pharmaceutical industry is not one to take \nall this lying down. It&#8217;s fighting back on all fronts, in a series of vicious \nattacks, coupled with consumer manipulation that so characterize a desperate \nindustry.\n<\/p>\n\n\n\n<p>Before we study the attack strategy of big pharma, lets get to know \nthe industry a little better and the regulation that defines its operating \nparameters.\n<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><b>A Little Bit of US Drug History<\/b> <\/h3>\n\n\n\n<p>Miracle drugs and pervasive drug advertising have been a staple of the \nAmerican diet for both the body and the mind for over a hundred years.\n<\/p>\n\n\n\n<p>After more than 30 years of pressure for food and drug safety laws, \nthe year 1906 finally ushered in the landmark Pure Food and Drug Act, amid \nshocking disclosures of the use of poisonous food additives and cure-all \nclaims for worthless and dangerous patent medicines.\n<\/p>\n\n\n\n<p>In 1927 the Food and Drug Administration (FDA) was formed as the regulatory \narm of the government charged with enforcing food and drug law. The pharmaceuticals \nlost their battle against an overhaul in drug regulation in 1937, after \na drug known as the Elixir of Sulfanilamide killed over a 100 people, including \nmany children. This paved the way for the passage of the 1938 Food, Drug \nand Cosmetic Act which, among other things, required new drugs to be shown \nsafe before they could be marketed. The Thalidomide scare of the early \n1960s put pressure on Congress to further strengthen drug regulation. Still, \nthe brand-name companies continued to prosper because they could set whatever \nprice they wanted on patented drugs.\n<\/p>\n\n\n\n<p>The year was 1984 when pharmaceutical companies first started seeing \nthose shark fins emerge on the horizon, with the passage of the landmark \nHatch-Waxman Act. Prior to this, generic drug companies had to perform \nthe same rigorous testing on generic drugs that the companies with the \ninitial patent had to perform. This made competition from generics virtually \na non-issue because the investment required to get regulatory approval \ncould only reasonably be recovered where the producer could charge a sufficiently \nhigh price for the drug once approved. In practice, this meant that the \npre-Hatch-Waxman regulatory structure was heavily biased in favor of the \ncompanies with drug patents &#8211; that is, the brand name drug companies.\n<\/p>\n\n\n\n<p>The 1984 Drug Price Competition and Patent Term Restoration Act (often \nreferred to as the Hatch-Waxman Act) changed the drug competition landscape \ndrastically by lowering the regulatory hurdles for generic companies. It \nsaid that, rather than the generic companies performing all the safety \ntests that the original company with the patent carried out, they just \nhad to show that the generic drug was chemically the same as the original \ndrug, which had already been tested. Finally, there was a feasible economic \nmodel for the generic industry. Once a patent expired on a drug, they could \nreplicate and sell that drug for a lower cost and still make a profit, \nbecause their initial costs to get the drug to market were now much lower.\n<\/p>\n\n\n\n<p>Well, that part of the 1984 law sounds pretty good for the consumer! \nBut lets be realistic &#8211; Do you really expect the government, especially \nduring the Reagan administration, to turn its back so abruptly on its buddies \nin the pharmaceutical industry just to create a deal for the consumer?\n<\/p>\n\n\n\n<p>It is one of the oldest tricks in the regulatory book to create a law \nthat looks pretty damn good to the general public, but with some back door \ngifts to friendly private interests that are not obvious to the general \npublic until many years later. The Trojan Horse allowed into the 1984 regulatory \nregime contained an army of methods for the brand-name companies to fight \nthe generics, including:\n<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\nExtension of patent protection to make up for time lost in the FDA regulatory \napproval process (hence the term &#8220;Patent Restoration&#8221;).<\/li><li>\nAbility to get multiple patents on drugs covering not only the chemical \nitself, but also all kinds of preparation methods and techniques, making \nit harder for the generics to prove they had the same drug. These patents \ncould be staggered, such that when the patent on the main chemical expired \nthe patents on various methods and techniques were still in force.<\/li><li>\nWide ranging ability to challenge generic companies in the courts for patent \ninfringement.<\/li><\/ul>\n\n\n\n<p>These back door methods available to keep patents going form a major arm \nof the strategy used by the brand-name companies to ward off the threat \nfrom generics. And it is these very loopholes that coalitions such as &#8220;Business \nfor Affordable Medicine&#8221; and many congressional representatives are trying \nto close.<\/p>\n\n\n\n<p>In later years the arsenal was to be extended by the formation of the \nWorld Trade Organization and associated revisions to international trade \nlaw that further strengthened patent protection of pharmaceuticals.\n<\/p>\n\n\n\n<p>Then, starting in about 1994, the brand name companies launched into \na shameless, near exponential growth in direct-to-consumer advertising \nof prescription drugs for reasons that probably have to do with increasing \npressure from generic competition and managed-care companies. This strategy \nproved critical in the battle against the Shark Fin Curve. Nowadays, barely \nan hour can go by on the TV without us hearing from our friends in Big \nPharma.\n<\/p>\n\n\n\n<p>Meanwhile, in other industrialized nations, the provision of universal \nhealthcare means that drug prices are largely controlled by governments. \nDrug companies have not been allowed such freedom to either set prices \nfor patented drugs or to advertise directly to the consumer. Consequently \nthe US consumer ends up not only paying for the privilege of being propagandized \nby the drug companies at home, they also subsidize lower drug costs abroad \nwhere prices are regulated by the government.\n<\/p>\n\n\n\n<p>Put all these factors together and there&#8217;s little mystery as to why \nprescription drug costs are spiraling out of control in this country, increasing \nat about 15% a year!\n<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><b><a name=\"counter\"><\/a>The Anatomy of a Counter-Attack from  Big Pharma<\/b> <\/h3>\n\n\n\n<p>To understand where some of the most unsavory behaviors of the branded \ndrug companies come from, it is instructive to look at several case studies. \nWe will look at two of the most frequently referenced case studies, whose \nstories can never be told enough. Be sure to tell all your friends, too!\n<\/p>\n\n\n\n<p><b>Case Study 1 &#8211; Blockbuster Nexium:<\/b> The marketing of the heartburn  drug Nexium by AstraZeneca to counter the expiry of its patent on the similar  drug Prilosec.  Schering-Plough is currently using similar tactics to convert  people from the allergy drug Claritin coming off patent, to the almost  identical branded drug Clarinex. <\/p>\n\n\n\n<p><b>Case Study 2 &#8211; Blockbuster Taxol<\/b>: The tactics of Bristol-Myers \nSquibb to keep its monopoly on the cancer drug Taxol, originally a gift \nfrom the taxpayer funded National Institutes of Health\n<\/p>\n\n\n\n<p>These case studies come from a very educational series in the Wall Street \nJournal that has been running throughout 2002 documenting the tactics of \nthe pharmaceutical industry.\n<\/p>\n\n\n\n<p><i>Case Study 1: Blockbuster Nexium, by AstraZeneca (WSJ June 6, 2002)<\/i>\n<\/p>\n\n\n\n<p>Thanks to their bad eating habits, American are notorious for stomach \nrelated problems, and this has proved to be a gold mine for the drug industry. \nStomach ulcer and heartburn drugs like Prilosec, and Zantac before it, \nwere the largest selling blockbusters of their time.\n<\/p>\n\n\n\n<p><i>Insert: 1940s &#8220;American Stomach&#8221; Radio Ad<\/i>\n<\/p>\n\n\n\n<p>In 1995 AstraZeneca launched &#8216;Project Shark Fin&#8217; to draw up a battle \nplan as its 6 billion-dollar-a-year heartburn drug, Prilosec, was going \nto lose its patent in April 2001. After years of work, the Shark Fin team \ncame up with the rather unimaginative solution of launching a successor \ndrug that was basically the same as Prilosec, but would be under patent \nwhen Prilosec lost its patent. They also used every loophole available \nin the Hatch-Waxman Act to construct a legal minefield for would-be copy-cats, \nto extend the Prilosec patent as long as possible, and give AstraZeneca \nmore time to convert Prilosec users over to Nexium. The related legal battles \nover the Prilosec patents continue to this day and are closely watched \nby those that follow drug prices.\n<\/p>\n\n\n\n<p>To convert post-patent Prilosec users to its patented sibling Nexium, \nAstraZeneca spends about $0.5 billion a year in adverting of this single \ndrug, making it now the most advertised drug in the US (taking over from \nPrilosec a few years ago). And, so far that&#8217;s paid off handsomely, as 60% \nof those switching from Prilosec are going to Nexium.\n<\/p>\n\n\n\n<p>Nexium is one-half the Prilosec molecule and works pretty much the same, \nbut it is just chemically different enough to win a patent of its own. \nThe marketing spin that Nexium is better at dealing with eroded esophagus \nis good for converting Prilosec users that watch prime time TV over to \nNexium but, according to the Wall Street Journal article, is built on very \nshaky scientific foundations. According to this article, four studies were \ncommissioned to see if Nexium was better at healing eroded esophagus. Two \nstudies found it wasn&#8217;t any better at all and the other two found it was \nbetter only by a smidgen.\n<\/p>\n\n\n\n<p>Based on that piddling bit of evidence we all get to hear about eroded \nesophagi and purple pills with racing stripes on a daily basis!\n<\/p>\n\n\n\n<p>Such tactics form a common strategy for maintaining revenue as drugs \ncome off patent. A similar strategy is being employed to convert users \nof the allergy drug Claritin to the new patented Clarinex.\n<\/p>\n\n\n\n<p><i>Case Study 2: Blockbuster Taxol, by Bristol Myers Squibb (WSJ June \n5, 2002)<\/i>\n<\/p>\n\n\n\n<p>Bristol-Myers Squibb is currently being sued by 29 states for illegally \ndelaying generic competition of its blockbuster cancer drug Taxol and costing \ngovernments and consumers billions of dollars, as well as costing lives. \nThe basis of the suit is the claim that Bristol-Myers Squibb misled the \nUS Patent Office to delay generic competition on Taxol.\n<\/p>\n\n\n\n<p>But it gets more offensive than this! You see, Taxol is derived from \nthe bark of the Pacific Yew tree and its pharmaceutical benefits were discovered \nnot by Bristol-Myers but by the taxpayer-funded National Institutes of \nHealth. The NIH handed Taxol over to Bristol-Myers in 1991 as a big gift. \nIn return Bristol-Myers, who charges a hefty price for Taxol, has acted \nlike a badly spoiled child not wanting to share this gift with anyone, \neven ten years later.\n<\/p>\n\n\n\n<p>Bristol-Myers Squibb, similar to what AstraZeneca did in setting up \nits minefield around Prilosec, has used the trick of staggered patents \nof every technique and methodology used to serve up Taxol to maintain its \nmonopoly on the taxpayers&#8217; gift to them.\n<\/p>\n\n\n\n<p>This is such a common strategy of counter-attack by the brand name companies \nagainst the generics that state governments, consumers, companies and health \ninsurers that end up footing the bill for prescription drugs are themselves \nchallenging it at every turn.\n<\/p>\n\n\n\n<p>Poor Bristol-Myers Squibb! In addition to these lawsuits and angry governments, \nthe planned heir to the cancer drug throne, a drug known as Erbitrix, developed \nin a joint venture with ImClone Systems, was rejected by the FDA and wound \nup in a sordid scandal with the queen of good cooking &#8211; Martha Stewart. \nWhat are they going to do with the Shark Fin now?\n<\/p>\n\n\n\n<p>These case studies were selected to give an idea of the desperate tactics \nused by the drug industry to boost sales revenues. But, of course, the \ntactics don\u2019t stop there. Following is a small sampling of other techniques \nemployed to keep sales revenues and drug prices high.\n<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\n<i>Marketing to the medical profession.<\/i> (Source: Kaiser Foundation \nStudy, 11\/2001) Drug companies spend the vast majority of their direct \nmarketing budgets (about 85% of them) not on marketing directly to the \npublic, but on marketing directly to doctors. This consists mostly of giving \ndoctors buckets full of free samples &#8211; about $8 billion worth in 2000 &#8211; \nnoting that patients who start on free samples often convert to paying \ncustomers. It also includes giving doctors free dinners, sports tickets \nand other gifts, sponsoring conventions for them, and advertising in medical \njournals. In all, marketing to the medical profession costs the drug industry \nabout $14 billion a year.<\/li><li>\n<i>Advertising to consumers through pharmacies. <\/i>(Source: WSJ 5\/1\/2002)<i> \n<\/i>This newest form of direct-to-consumer advertising comes in the form \nof what looks like an educational booklet from the pharmacy about various \ntreatments for your particular condition. It&#8217;s provided for free when you \npurchase your prescription drugs, and looks like a public service provided \nby your trusted pharmacy. The targeted consumer would have to get their \nmagnifying glasses out to see that these are actually advertisements from \nthe branded drug companies. The trusted pharmacies are, of course, amply \ncompensated for their distribution efforts and access to their databases \nfor target marketing purposes.<\/li><li>\n<i>Advertising Agencies Participating in Clinical Trials: <\/i>(Source: \nWSJ 6\/3\/2002)<i> <\/i>Believe it or not, those same drug agencies that bring \nus the subliminal messages of eroded esophagi using big canyons, are entering \nthe business of performing clinical trials for their clients. This should \nlower both advertising costs and expenses of clinical trials, for there \nis every incentive for the advertising agency to find that their tested \ndrug is just fantastic. After all, they will have an exclusive on the advertising \naccount once the product is launched.<\/li><\/ul>\n\n\n\n<p>As noted, these case studies and other techniques are just a small sampling \nof the techniques the branded drug companies use to stay alive and profitable \nin the face of competition, decreased innovation and increasing opposition \nfrom many quarters. There are many more strategies employed and if you \nread the business press you can probably read about a new one just about \nevery day. Indeed, it is remarkable that the granting of 20-year monopolies \nand the gifts of publicly funded research can&#8217;t even help this industry \nsolve its profitability problems, let alone that it increasingly fails \nto provide value-added service to the public. Surely it is time to re-think \nthe viability and sustainability of the branded drug sector in its current \nform.<\/p>\n\n\n\n<p><b>[ The following Section 6 was deleted from the audio version for \ncontinuity reasons, but you might find it interesting&#8230;<\/b><b><\/b>\n<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><b>The Next Blockbuster Drug &#8211; What will  it be? A &#8220;Youth Pill&#8221;<\/b> <\/h3>\n\n\n\n<p>As we&#8217;ve already seen, the blockbuster cabinet is currently looking \npretty bare, and big pharma is getting nervous. Many recent blockbusters \nact on certain enzymes to inhibit their production of an undesired chemical \nthat causes problems like high cholesterol. But the enzymes available for \nsuch targeting are pretty much used up by now by all the existing blockbusters. \nIn addition, it will be hard to improve on existing treatments for the \n5 main ailments that currently dominate the top 20 drug lists &#8211; heartburn, \narthritis, high cholesterol, high blood pressure and low spirits (depression). \nSo what next?\n<\/p>\n\n\n\n<p>Operating in the favor of big pharma profitability is the aging of the \nrich world populations with money to buy prescription drugs. This aging \nin the West will drastically increase per capita spending on prescription \nmedicines in the coming years. Finding effective medication for the degenerative \naltzheimers disease or even osteoporosis would be like hitting the jackpot. \nBut with few warm leads on such cures, investing R&amp;D monies in this \narea is certainly very risky.\n<\/p>\n\n\n\n<p>In it&#8217;s efforts to produce a blockbuster for the over 65s, the biggest \ndrug giant Pfizer has recently been working on the elusive &#8220;fountain of \nyouth&#8221; pill, also known as the &#8220;frailty pill&#8221;. By stimulating the pituitary \ngland to produce more growth hormone, this drug aims to reverse the degenerative \nprocess that comes with aging and make old people feel young again. Taking \nthe trend set by drugs such as Viagra, Rogaine and Paxil to a whole new \nlevel, this drug promises to be the ultimate &#8220;lifestyle drug&#8221; for the baby \nboomer generation. But so far the clinical trials have not produced the \ndesired results.\n<\/p>\n\n\n\n<p>Nevertheless, if the drug companies could get the youth pill to work \nthen, by playing on one of the deepest of human fears, they will have struck \ngold. Consumers might start taking such medications at the first signs \nof old age and then be taking them for the next 50 years!\n<\/p>\n\n\n\n<p>Another strategy we are likely to find followed more is the use of &#8216;gene \nhunting&#8217;, where researchers try to discover the genetic roots of chronic \ndiseases and thereby devise treatments. But payoffs from gene technology \nare not expected for another decade or so.\n<\/p>\n\n\n\n<p>In the midst of this current drought in the blockbuster drug pipeline, \nmany industry watchers have noted that increasing consolidation has actually \nmade the drug industry <i>less<\/i> efficient at producing more drugs.\n<\/p>\n\n\n\n<p>But that&#8217;s not the worst of it, by far. The patented medicine model,  while contributing much to the welfare of the western world over the past  century, has itself aged and entered a seriously degenerative phase. It  is not making much sense in our globalized markets, and maybe it&#8217;s time  for it to die out. Today, people all over the world, regardless of nationality,  political ideology, or wealth, should seriously be questioning the suitability  and sustainability of the contemporary patented medicine model.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><b><a name=\"failure\"><\/a>Market failure of the Patented Medicine  Model. HIV\/AIDS Rips in to China and Russia.<\/b> <\/h3>\n\n\n\n<p>The following, seemingly prophetic, quote from an 1851 edition of the \n<i>The Economist<\/i> describes perfectly the degenerative phase the patented \nmedicine model has reached by the start of the 21<sup>st<\/sup> century:\n<\/p>\n\n\n\n<p>&#8220;The public will learn that patents are artificial stimuli to improvident \nexertions; that they cheat people by promising what they cannot perform; \nthat they rarely give security to really good inventions, and elevate into \nimportance a number of trifles&#8230;no possible good can ever come of a Patent \nLaw, however admirably it may be framed.&#8221;\n<\/p>\n\n\n\n<p>This 1851 quote gives a good description of what has become of today&#8217;s \npharmaceutical sector when viewed from a global perspective. Patents have \ncertainly provided &#8220;artificial stimuli to improvident exertions&#8221; or, put \nanother way, wasteful spending. And there is no question that we have seen \nthe elevation &#8220;into importance a number of trifles&#8221;, namely the blockbuster \nlifestyle drugs such as Viagra, Rogaine, and various anti-depressants, \nas well as unnecessary drugs that are virtually the same as a host of other \ndrugs already on the market. All this takes places against the backdrop \nof a developing world HIV\/AIDS crisis that has resulted in up to 40% of \nthe population being infected in some African counties, and is now starting \nits exponential growth throughout Eastern Europe, the former Soviet states, \nChina and the rest of South-East Asia.\n<\/p>\n\n\n\n<p>The West has remained largely unconcerned with the HIV\/AIDS crisis in \nAfrica. There have been some nice efforts from various quarters but so \nfar the response has been woefully inadequate from those that can most \nafford to help. To put it bluntly, this is because the &#8220;self-interest&#8221; \ncomponent just isn&#8217;t there. Africa is only a minor trading partner with \nthe West, and the West has relatively little economic interest in Africa. \nSo far, all the help adds up to not enough, and the disease continues to \noutpace efforts to stop it. Out of a $10 billion-a-year request from the \nUN, the West can only bare to part with $2 billion to assist in dealing \nwith the problem of HIV\/AIDS in the developing world. And, compared to \nother drug investment, relatively little goes into finding a vaccine. If \nand when a vaccine is available, distribution of it will pose the next \nmajor hurdle.\n<\/p>\n\n\n\n<p>But now, there are increasing reports detailing the spread of HIV\/AIDS \nthroughout the former or semi-communist, now market-directed, nuclear powered \ngiants &#8211; Russia and China. A startling report from UNAIDS, released in \nJune 2002 entitled &#8220;HIV\/AIDS: China&#8217;s Titanic Peril&#8221; reveals the state \nof the problem of HIV\/AIDS in China. With 1-2 million people infected today, \ninfection rates have been increasing at more than 50% a year. Estimates \nof the number of people infected by 2010 range between 10 and 20 million. \nThe former Soviet states have seen a five-fold increase in infections in \nthe past three years, have more than 1 million people infected, and the \nfastest spreading epidemic of all, according to a September 2002 UN Report. \nA survey from British scientists released in June predicts that within \n5 years, 1 in every 20 Russian adults will be infected.\n<\/p>\n\n\n\n<p>Both China and Russia are rapidly developing market economies. One is \na major trading partner of the United States, the other set to become one \nof the European Union. Lest you think this development will help, think \nabout the African nation of Botswana. Botswana was the golden child of \neconomic development of sub-Saharan Africa, financed largely by its mining \nindustry after it gained independence. Its first AIDS case was detected \nin 1985, then HIV\/AIDS built slowly for several years. By the 1990s it \nwas spreading furiously throughout the general population so that by 2002 \nit affects almost 40% of the entire population. Why so much worse than \nthe less developed sub-Saharan region, you might be wondering? Largely \nbecause of the rapid economic development itself. The road networks that \ncome with development, the mobility of labor away from home and families \nthat comes with globalization, and men leaving wives to get work, all sped \nup the spread.\n<\/p>\n\n\n\n<p>Now, many people in Africa think China and Russia look a bit like their \ncountries did five to ten years ago. But there&#8217;s more. With Western style \ndevelopment comes rapid growth in drug use, teenage sex, commercial sex \nand poverty. These increases are being observed across China, Eastern Europe \nand Russia and the relevant populations are showing huge increases in infection. \nIn addition, the old social safety nets and health care systems have largely \ncollapsed. In rural China, the poverty of farmers has forced them to sell \ntheir blood for trade on the lucrative national and international plasma \nmarkets. Millions of rural people participated in these plasmapheresis \nprograms in return for cash payments to supplement their ever-dwindling \nincomes. In this process their blood was taken, pooled with that of lots \nof other people, and the plasma separated from the red blood cells. The \nplasma is sold on the plasma market and the now pooled red blood cells \nare then re-infused back into the pool of donors so that they can keep \ngiving blood at a high frequency. In such a process, all it takes is for \n1 person in a pool of 100 to have HIV and all 100 get it. This has greatly \nincreased China&#8217;s HIV problem. Add this to the fact that population pressures \nand the preference for male children has created a dangerously high and \nunnatural male to female ratio, plus the big taboo on discussion about \nsex in eastern cultures, and you see a growing number of catalysts for \ndisease spread.\n<\/p>\n\n\n\n<p>China is currently the forth-largest trading partner of the US, likely \nto be the number 2 or 3 before too long, and with a strong chance of becoming \nnumber 1. With China joining the World Trade Organization there&#8217;s tons \nof capital wanting to invest in China. As residents and consumers in the \nUS, our lives are undeniably intertwined with those of the Chinese. So \nmuch of our own purchasing power and hence, quality of life, is a direct \nresult of the relatively low cost of labor in China. As our population \nages, more and more of the productive labor force we depend on will be \nin countries like China. In this case, the economic interests of the US \nare very much tied up with the well being of the labor force of China. \nIf the US does for China&#8217;s emerging epidemic what it did for Africa, which \nwas not very much, the consequences on the US economy could be quite severe. \nMaybe this self-interest component is the only thing that can get the US \nto do what it can well afford to do about this crisis in the developing \nworld. Then, I am sure, a vaccine could be found and distributed in no \ntime at all.\n<\/p>\n\n\n\n<p>Similar arguments apply about the relationship between Western and Eastern \nEurope. The European Union has an added incentive. Since this is all happening \nright next door, the epidemic may very well stretch into Western Europe \nif they don&#8217;t help do something about it in a hurry.\n<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><a name=\"remedy\"><\/a><b>A Remedy for the Ills of the Current Medicine  Model<\/b> <\/h3>\n\n\n\n<p>There is no point asking the branded drug industry for help. They just \nwont budge without a monopoly and a profit stream, neither of which is \na suitable incentive model for this global crisis. It is heartbreaking \nto see the present $8 billion shortfall in the UN requests for HIV\/AIDS \nassistance, compared to the many tens of billions spent by the pharmaceutical \ngiants on advertising nonsense pills to us daily, suing the generics at \nevery turn and developing medicines that aren&#8217;t really necessary. And we \nend up footing the bill for all this, be it in the form of our taxes, higher \nhealth premiums or direct prescription purchases.\n<\/p>\n\n\n\n<p>If global capitalism wants to save itself from its own worst enemy &#8211; \nwhich is itself &#8211; it better act quick smart. Following is a prescription \nfor the capitalists to save their global markets&#8230;\n<\/p>\n\n\n\n<p>(1) Since the branded drug industry is wasting our time and our money \nand they are not helping to solve the really big and important health problems, \nwe can conclude they are a big inefficient sector of the markets due to \ntoo many years of monopolies and taxpayer subsidies. They are fired! That \nshould make the markets more efficient. We will keep the generics, though.\n<\/p>\n\n\n\n<p>(2) The generics can keep producing all existing FDA approved drugs \nin a patent free environment. This should lower our total annual drug costs \nby about $80 billion a year.\n<\/p>\n\n\n\n<p>(3) We will use about $15 billion of this for a prescription drug benefit \nfor seniors (whose costs are now much lower because all drugs are generics) \nand put some $15 billion towards insuring the uninsured.\n<\/p>\n\n\n\n<p>(4) We will set aside $30 billion for drug research and development \nin the public sector, to replace what the private sector used to do, except \nwith a more needs oriented approach. All the scientists, researchers and \nadministrative workers from the now extinct brand name companies get new \njobs at the new publicly funded research centers. Realizing that the biggest \nneeds are in the developing world and that our own economy is intimately \ntied to their well being in this globalized world, we set the first $15 \nbillion aside exclusively for HIV\/AIDS vaccines and treatments. The next \n$5 billion goes on tropical diseases, tuberculosis and so forth. Then the \nother $10 billion will go into the most important things at home.\n<\/p>\n\n\n\n<p>We still have $20 billion left.\n<\/p>\n\n\n\n<p>(5) Of the people that used to work for the branded drug companies, \nwe still have the marketing people and lawyers sitting around idle, which \nis worrisome. Since the marketing people are always telling us that they \nare not annoying and that they are instead providing the social service \nof distributing important information, we have just the job for them! First \nthey will be put in decompression chambers and then some training will \ntake place to retool them for a more wholesome career. They will each be \nprovided with 10,000 packets of condoms and sent all over the world from \nIndia to the Congo to Russia to China to Brazil. Their job will be to sell \nthe use and advantages of condoms and safe sex to as many people in the \ndeveloping world as possible. This should be right up their ally. For years \nthey have been walking into doctors offices with free samples to give away \nand stories to tell. They will get compensated based on the preventative \npractices adopted in their region. The total cost of the global prevention \nplan will be about $10 billion.\n<\/p>\n\n\n\n<p>(6) The lawyers will be left on their own. They are inventive enough \nto find other ways to occupy their time.\n<\/p>\n\n\n\n<p>(7) Well, there&#8217;s lots that can be done with the remaining $10 billion  and I&#8217;ll just leave that up to your imagination. \u00a0 <\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>That&#8217;s all for the Wizards of Money Part 16.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This is the Wizards of Money, your money and financial management series, but with a twist. My name is Smithy and I&#8217;m a wizard watcher in the Land of Oz.&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-116","post","type-post","status-publish","format-standard","hentry","category-podcast"],"_links":{"self":[{"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/posts\/116","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/comments?post=116"}],"version-history":[{"count":2,"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/posts\/116\/revisions"}],"predecessor-version":[{"id":146,"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/posts\/116\/revisions\/146"}],"wp:attachment":[{"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/media?parent=116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/categories?post=116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/earlywithdrawal.net\/wizardsofmoney\/index.php\/wp-json\/wp\/v2\/tags?post=116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}