The drug industry’s chokehold on america’s health care

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The drug industry’s chokehold on America’s
health care
By Joanne Laurier
3 January 2005
The Truth About the Drug Companies: How They Deceive Us and What In 1980, Congress enacted a series of laws, such as the Bayh-Dole Act to do About it by Marcia Angell M.D., published by Random House, 304 (Senator Birch Bayh [D-Indiana] and Senator Robert Dole [R-Kansas]) pp.; Overdosed America: the Broken Promise of American Medicine, by that enabled universities and small companies to patent discoveries made John Abramson, M.D., published by Harper Collins, 332 pp.
through publicly funded research and then grant exclusive licenses to drug Major pharmaceutical companies have been hit recently by an array of companies. Until that time, taxpayer-financed research was public scandals regarding the safety of certain “ blockbuster” drugs. Merck’s property available to any company. The nascent biotech industry was thus Vioxx, a leading arthritis and pain medication was withdrawn from the given a tremendous boost. Through similar legislation, the National market after it was shown to have caused thousands of heart attacks and Institutes of Health (NIH)—the major distributor of tax dollars for medical an estimated 55,000 deaths. Its leading competitor, Celebrex, research—was permitted to enter into deals that would directly transfer manufactured by Pfizer, faces similar difficulties.
Other drugs, including over-the-counter remedies, are also being As Angell points out: “These laws mean that drug companies no longer scrutinized for severe, unwanted side-effects. On December 18 the Detroit have to rely on their own research for new drugs, and few of the large Free Press released its own analysis concluding that many thousands of ones do. Increasingly, they rely on academia, small biotech start-up Americans are getting sick and dying from prescription drugs prematurely companies, and the NIH for that.” (p. 8) This, argues Angell, has changed the ethos of medical schools and teaching hospitals, who now see Two recently-published books provide valuable insights and describe in themselves as partners of industry and become “just as enthusiastic as any devastating detail the operations of the pharmaceutical industry—the entrepreneur about the opportunities to parlay their discoveries into consequences of its domination of government agencies and the medical financial gain.” (p. 8) She cites the example of the Dana-Farber Cancer establishment. The Truth About the Drug Companies: How They Deceive Institute, a Harvard hospital, which has a deal with the drug company Us And What To Do About It is written by Marcia Angell, M.D.; Novartis, giving it rights to discoveries that lead to new cancer drugs.
Overdosed America: The Broken Promise of American Medicine is In 1984, the Hatch-Waxman Act extended monopoly rights for brand-name drugs—drugs for which the manufacturer has marketing A former editor-in-chief of the New England Journal of Medicine ( exclusivity. (After brand-marketing rights expire on a drug, generic copies NEJM), Angell witnessed the work of that prestigious journal come can be produced by any manufacturer for a fraction of the cost. The increasingly under the influence of the drug industry. She claims in the monopoly status of a brand-name drug also translates into an exorbitant volume’s introduction that the pharmaceuticals began exercising “a level selling price by comparison with its generic equivalent.) Other of control over the way research is done that was unheard of when I first congressional laws enacted in the 1990s have increased the patent life of came to the journal, and the aim was clearly to load the dice to make sure brand-name drugs from 8 years in 1980 to 14 years in 2000.
In 1992 Congress passed the landmark Prescription Drug User Fee Act, The author of Overdosed America, Abramson, is a family doctor on the effectively putting the Food and Drug Administration (FDA) on the clinical faculty of Harvard Medical School. He was prompted to write his pharmaceutical industry’s payroll, according to Angell. To expedite book because of what he perceived as the corporate takeover of medical approval of drugs, the law authorized drug companies to pay user fees to research. Trained as a statistician, he “ researched the research,” and the FDA, making the governmental agency dependent on the industry it found that “even the most respected medical journals seemed more like regulates. Today, industry-paid FDA employees constitute more than half infomercials whose purpose was to promote their sponsors’ products of the agency’s staff involved in approving drugs. The FDA now rather than to search for the best ways to improve people’s health.” (p.
generally approves drugs faster than counterpart agencies anywhere in the world. Since the law was enacted, 13 prescription drugs, causing hundreds Americans spend a staggering $200 billion a year on prescription drugs of deaths, have had to be withdrawn from the market.
out of worldwide sales of $400 billion. From 1980 to 2000, prescription The origin of the FDA is not discussed extensively by either Angell or drugs tripled as a percentage of US gross domestic product. Since that Abramson, but a brief historical review would be in order. The agency time, PhRMA—the Pharmaceutical Research and Manufacturers of was established in 1906, by the Food and Drug Act, partially in response America—has consistently ranked by far as the most profitable industry, to exposures such as muckraker Upton Sinclair’s famous novel, The while its CEOs have raked in eight digit salaries combined with eight Jungle, treating the appalling conditions in Chicago’s slaughterhouses.
digit stock options. In 2002, the combined profits of the 10 drug Several medical disasters in 1937 and 1938 compelled President companies in the Fortune 500 ($35.9 billion) were more than the total Franklin Roosevelt in the New Deal era to sign the Food, Drug and profits of the other 490 businesses ($33.7 billion).
Cosmetic Act of 1938, which brought cosmetics and medical devices Both Angell and Abramson contend that PhRMA began its astronomical under government control and required that drugs be labeled with rise in the late 1970s and early 1980s—particularly under Ronald Reagan.
adequate directions for safe use. The quarter century that followed the 1938 bill saw a vast expansion of the pharmaceutical industry. As science easier for the patient to take a prescription. The expansion of the matured and patent laws changed—making possible the profitable control definition increases the demand for medication by millions of customers.
of a drug by the company that owned it—the industry discovered, The cholesterol-lowering drug Lipitor was the top-selling drug in the developed and marketed drugs, some of which no doubt had important world in 2002, followed by its competitor Zocor. Similar processes are at work with remedies for other ailments, such as hypertension.
Drug companies also used the 1938 law to devise the concept of While me-too, or copycat, drugs flood the market—proliferating in many prescription drugs—drugs available only through physicians at a price set cases because of an industry-created demand—there are growing shortages for life-saving medicines, as companies try to free production capacity for Anti-regulatory action began under the Carter administration, but drugs with bigger market potential. Angell reports that in 2001 there were Reagan slashed the FDA’s enforcement budgets in earnest. The routine serious shortages of drugs to treat premature infants, antidotes for certain actions by which the agency kept contaminated foods and problem drugs drug overdoses, and an anti-clotting drug for hemophilia, as well as drugs off the market—seizures, injunctions and prosecutions—dropped used for cardiac resuscitation and gonorrhea and vaccines against flu and dramatically. The limits of the FDA budget paved the way for the 1992 pneumonia, among other much-needed remedies. This season’s flu bill, which provided additional funds for the agency—by putting it at the vaccine shortage in the US imperiled thousands of high-risk sections of service of the pharmaceutical industry.
the population, including the elderly, children, pregnant women and those Bringing the companies into the drug approval process was vital for the with chronic and life-threatening diseases such as cancer.
pharmaceuticals because patents on new drugs are usually obtained before The situation is particularly stark in relation to the development of drugs clinical testing begins, thereby eating into a drug’s 20-year patent life—the for life-threatening diseases common in underdeveloped countries. In time it can be sold without competition. To maximize profitability, the contrast to the cornucopia of drugs to treat erectile dysfunction, mood drug companies are under pressure to shorten the trials so that marketing disorders, hay fever and heartburn, the pharmaceuticals are largely uninterested in developing drugs to treat widespread tropical diseases like As public opposition to rapacious drug pricing has grown, Angell malaria. Under the Clinton administration, the pharmaceuticals reveals that the industry’s media campaign to counter this centers on its vehemently opposed South Africa’s threat to produce or import generic claims to be innovative. “Big pharma likes to refer to itself as a drugs to control its raging HIV/AIDS epidemic. While the Clinton ‘research-based industry,’ but it is hardly that.”(p. 73) In reality, the administration was eventually forced to back off from its warning of trade budget of the drug companies for research and development is dwarfed by sanctions at the behest of the drug industry, the Bush administration stood massive marketing expenditures. Only a handful of important drugs have alone among 143 World Trade Organization countries in opposing the been developed—mostly based on taxpayer-funded research—in recent relaxation of patent protection for HIV/AIDS medicines for Third World years. (R&D costs are tax-deductible.) This despite the fact that the number of clinical trials under way in any given year is staggering. In Angell cites some of the more egregious examples of 2001, about 2.3 million American were involved in an estimated 80,000 direct-to-consumer (DTC) advertising. DTC was made legal in 1981 and extended in 1997 by allowing that only major side effects and “The great majority of ‘new’ drugs are not new at all but merely contraindications had to be included in the media ads. The sky was then variations of older drugs already on the market. These are called ‘me-too’ the limit: GlaxoSmithKline and its co-marketer Bayer signed a deal with drugs. The idea is to grab a share of the established, lucrative market by the National Football League to promote Levitra, the me-too erectile producing something very similar to a top-selling drug,” (p. xvi) writes dysfunction competitor of Viagra. Angell quips: “In fact, to watch the Angell. For example, there are six cholesterol-lowering drugs (Mevacor, 2004 Super Bowl was to wonder whether football causes erectile Lipitor, Zocor, Pravachol, Lescol and the newest, Crestor). She continues: dysfunction.” (p. 116) Pfizer, the maker of Viagra, then phased out its old “But instead of investing more in innovative drugs and moderating prices, and tired promoter Bob Dole in favor of baseball star Rafael Palmeiro.
drug companies are pouring money into marketing, legal maneuvers to The company also sponsors a Viagra car on the NASCAR circuit.
extend patent rights, and government lobbying to prevent any form of The explosion of drug ads in the 1990s coincided with the transition of many Americans to HMO-type health plans that covered the cost of In 2002, of the 78 drugs approved by the FDA, only 17 contained new prescription drugs. Researchers from Dartmouth Medical School found, active ingredients and only 7 were classified as improvements over their among other things, that two out of five ads attempted to medicalize older versions. Consequently, trouble may be looming for PhRMA. Some ordinary life issues. (“Routine hair loss or a runny nose, for example, of the top-selling drugs, representing combined sales of some $35 billion became a medical problem requiring treatment with expensive a year, are scheduled to go off patent within a few years of each other.
prescription drugs.” p. 154) Not only was advertising a boon for the drug Pharmaceuticals also extend the life of a blockbuster drug that is going industry, but it has also become the financial staple of many media off patent by creating another drug just different enough to qualify for a outlets; most medical journals are also dependent on drug ads for survival.
new patent and then shifting users to the new drug. AstraZenaca’s DTC ads are prohibited in every other advanced capitalist country except Nexium, a revamped version of the company’s older drug, Prilosec, is a case in point. Shortly before the patent for Prilosec was set to expire, the Angell asks: “If prescription drugs are so good why do they have to be FDA approved Nexium, which became the most heavily advertised drug pushed so hard?. Important new drugs require very little marketing.
in the US. “Today’s purple pill is Nexium, from the makers of Prilosec,” Me-too drugs, by contrast, require relentless flogging, because companies became a well-aired sound bite. After Nexium sales outstripped need to persuade doctors and the public that there is some reason to Prilosec’s, the latter became a non-prescription drug, selling for a fraction prescribe one instead of another.” (p. 133) Or perhaps instead of a far-cheaper, over-the-counter drug with equal or better benefits.
The market for existing drugs is also expanded by redefining what Big advertising agencies have become involved in the PhRMA constitutes medical need or illness. For example, the cutoff for high direct-to-consumer advertising bonanza. Madison Avenue giants such as cholesterol has been lowered over the years, from more than 280 Omnicom, WPP and Interpublic are cashing in. Omnicom owns a medical milligrams per deciliter to 240 and now to below 200. Although many education and communication company that ghostwrote the articles that doctors will recommend diet and exercise to achieve that level, it may be turned Neurontin, a drug originally approved for a very limited use affecting only around 250,000 people, into a blockbuster taken by One of the most serious risks attendant on the commercialization of millions. This was accomplished by marketing the drug for unapproved medicine, according to both Angell and Abramson, is “polypharmacy,” (“off-label”) uses. Angell notes that such practices are “illegal.” the taking of several prescriptions at once. Both authors point out that Covering all bases, the pharmaceutical companies also fund a major very few drugs have only one side effect. Besides the real possibility of portion of the costs of continuing medical education for physicians. They drug interactions, multiple drug taking likely leads to one of the drugs financially endow the meetings of professional organizations, such as the interfering with organ function. It would be extremely difficult to gauge American College of Cardiology and the American Society of with complete accuracy the implications of all the various side Hematology, where much of the continuing education for doctors takes effects—short term and long term—of multiple prescriptions on an place. This is combined with the $11 billion worth of “free samples” the individual. Drug testing is generally not slanted to produce such an drug companies gave doctors in 2001.
evaluation. In any event, multiple prescription takers don’t all imbibe the “Marketing a disease is the best way to market a drug,” notes the well-known breast cancer expert, Dr. Susan Love. Abramson quotes Love Drug company lobbyists, doling out tens of millions of dollars, are in Overdosed America in regard to the marketing of Premarin, a hormone extremely well connected to both Republicans and Democrats. Drug replacement therapy (HRT) drug. In an attempt to overcome bad publicity company influence reaches deep into the Bush administration. Defense that linked the drug to cancer in 1975, Premarin was rehabilitated as a Secretary Donald Rumsfeld was CEO, president and chairman of G.D.
drug to prevent osteoporosis. With the help of the National Osteoporosis Searle, a major drug firm that merged with Pharmacia and was then Foundation and a New England Journal of Medicine report on the positive bought out by Pfizer. The elder George Bush was on Eli Lilly’s board of effects of estrogen on heart disease, Premarin sales in 1992 once again directors before becoming president. The 2003 meeting of PhRMA soared to their 1975 levels. One out of five postmenopausal women in the featured Bush the elder, Secretary of Health and Human Services Tommy US was taking hormones. Premarin use increased another 40 percent over Thompson, former FDA Commissioner Mark McClellan and the the next three years and in 1995 became the most frequently prescribed chairman of the Republican Senatorial Campaign Committee, Senator In 1998, the results of the first randomized controlled clinical trial of Last year, former FDA chief McClellan, brother of White House press HRT were published, establishing that HRT increased women’s risk of secretary Scott McClellan, delivered a speech in Mexico in which he heart disease by 50 percent. Despite this, Premarin was still the third most excoriated other advanced countries for regulating drug prices, demanding frequently prescribed drug in the country. Premarin’s demise came with that the gap between the high costs of drugs in the US and those of other the well-publicized Million Women Study in 2003.
countries be bridged by the latter raising their own drug prices.
Abramson writes: “Twenty million American women have taken HRT “The heavy hand of big pharma is felt at all levels of government.
not only to relieve symptoms such as hot flashes and vaginal dryness but Nothing demonstrates that influence more plainly than the prescription also believing that hormones would protect their hearts, decrease drug benefit added to Medicare in late 2003,” writes Angell in The Truth Alzheimer’s and Parkinson’s disease, prevent tooth loss and diabetes, About the Drug Companies. (p. 193) Described by both authors as a strengthen their bones, preserve sexual function and urinary continence, gargantuan bonanza for PhRMA, the Medicare “reform” is dealt with in improve the quality of their lives, and increase their longevity. The more detail by Abramson. He notes that not only will the drug plan cost women who took HRT had access to the best care that American seniors more money (an average Medicare recipient who spent $2,318 medicine had to offer: Compared with the population at large, they were out-of-pocket for prescription drugs in 2003 will spend $2,911 in 2007), more likely to have graduated from college, were wealthier, and were but the bill also specifically prohibits the federal government from more likely to have received preventative care. Despite this, they negotiating prices with drug manufacturers. PhRMA also helped defeat an unwittingly exposed themselves to increased risks of breast cancer, heart amendment that would have funded research to determine which drugs attack, stroke, Alzheimer’s disease and blood clots.” (pp. 70-71) actually provide safe and effective treatment—a worthwhile endeavor Related to this development is the marketing of drugs for osteoporosis—a considering that 3 of the top 15 drugs most frequently prescribed for disease whose risks were largely unknown until the HRT educational American seniors in 2003 were Celebrex, Vioxx and Fosamax! campaign was initiated in 1982. Drugs such as Fosamax and Actonel While The Truth About the Drug Companies and Overdosed America became approved by the FDA. However, a 2001 study in NEJM showed have their independent areas of focus, there is much overlapping material.
that even women with severe osteoporosis derived only small benefit The contamination of science and the scientific process is a theme from these drugs. Although these drugs increase the score on bone-density seriously addressed by both Angell and Abramson. Unfortunately, their tests, they do not necessarily contribute proportionately to fracture works confirm that an in-depth analysis does not automatically lead to resistance. This is because the new bone, as a result of taking the osteoporosis drugs, is formed primarily on the cortical bone—the outer part Angell’s book ends with a whimper not a bang as she promotes the of the bone. Neither drug affects the locations of the body that have an notion that “most of the changes could be achieved with simple internal structure of trabecular bone, bone that provides additional congressional legislation.” Although she does mention that the strength in areas of the skeleton most vulnerable to fracture, such as hips, pharmaceutical industry should be “regarded much as a public utility,” demanding that its books be opened, her basic advice is to strengthen the “In the final analysis,” argues Abramson, “the ‘disease’ of age-related FDA; require that new drugs be compared not just with placebos but with osteoporosis is not a disease at all, but the quintessential example of older drugs for the same ailments; curb monopoly marketing rights; and successful ‘disease mongering.’ The drug industry has succeeded in prohibit direct-to-consumer advertising. As is often the case these days planting the fear that bones will suddenly and without warning ‘snap’ in with many such powerful exposés, the ensuing recommendations appear women who had naively believed they were healthy.” (p. 219) He further as an impotent wish list attached to the faint hope that the powers-that-be states: “The net effect of drug treatment on the risk of serious illness in can be persuaded to take the moral high ground and eliminate their the highest risk women? Nothing—except the cost of the drug” (p. 214).
Citing the NIH’s Study of Osteoporotic Fractures, the author reveals that On a somewhat different note, Abramson correctly states that the failure regular exercise achieved twice the reduction in hip fractures compared to of the market to serve American’s medical needs is not a “market failure, but a market success.” He adds: “Drug companies earn higher profits when more people use expensive drugs, not when people achieve better health. Doctors and hospitals are paid more for doing more, largelywithout regard for evidence of improved health outcomes. Health careproviders that deliver high quality, efficient care are financially penalizedfor not delivering a higher volume of more intensive services, beneficialor not (referred to as the ‘perverse incentive’).” He goes to on to say the“[A]merican politics, science, and health care has created an imbalancebetween corporate goals and public interest that is no longerself-correcting. In, fact, it was become resistant to correction” (pp.
254-256).
An advocate of universal health care, Abramson pushes for his versionof reforming the system. He believes that extending coverage to theuninsured would trigger a demand for accountability from industry andgovernment, thereby resurrecting the medical watchdogs. If Americanswould stop thinking that universal health care is “un-American,” thencommerce and the state would fall into line.
In fact, extricating medical science from the clutches of theconglomerates is bound up with a far greater social transformation, whichrequires an attack on the foundations of the present economic system. Thepresent disastrous state of health care in America, which results in tens ofthousands dying prematurely each year as the result of a lack of coverage,is the logical outcome of a medical system entirely subordinated to profit.
Protest and public awareness will not halt the process, nor will futileappeals to a bought-and-sold Congress.
The only rational solution to the crisis is a socialist program ofproviding universal, comprehensive medical coverage paid for by thegovernment and turning the giant pharmaceutical firms into publicutilities so that they can become the instruments for medical-scientificbreakthroughs beneficial to all.
Despite their political limitations, The Truth About the Drug Companiesand Overdosed America draw a disturbing picture of the inhumancharacter of production-for-profit in the medical sphere. The books are animportant contribution to exposing the utter incompatibility of the presentstate of affairs with the health and welfare of the population.
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