Pharming Out Healthcare: Who's Really Deciding Your Treatment?
Whenever we visit a doctor's office, we are reminded of the huge corporate interests which lurk around every corner of the healthcare system. Attractive and perfectly groomed pharmaceutical industry representatives – ladies for male doctors and gentlemen for females -- come and go at will, seeing doctors immediately regardless of how many people are in the waiting room. They bring smiles and gifts. In addition to samples of the latest medications, which they are there to promote, they leave notepads, clipboards, pens, examining table paper, charts and who knows what, all emblazoned with the name of the pharmaceutical company. Doctors are invited to expense-paid seminars where they are encouraged to promote the newest products -- the ones with patents which are not yet available as generics. Refusing to entertain such sales pitches could be the policy of the American Medical Association, but it isn't. New drugs are also marketed to potential patients via expensive, ubiquitous and affective advertising campaigns – a practice long since abandoned by the rest of the world.
But, aren't the latest meds the best meds? Not necessarily. For FDA approval, drugs must be shown to be better than a placebo. Few new drugs are tested against older medications for the same conditions. Furthermore, positive results are published, while negative results are buried; a couple of positive clinical trials can trump many negative ones on the same drug. No, the FDA doesn't have access to everything.
"Re-branding" allows big pharma to repackage identical drugs for use in often ill-defined conditions, which the industry deems to be profitable markets. One example of this is Eli Lilly's block-buster Prozac which it released with a new color and a new name as Sarafem, a treatment for Premenstrual Dysphoric Disorder (PMDD), a highly contested and little recognized condition. Sarafem hit the market in 2001, mere months before the patent on Prozac would have expired. A similar scenario occurred that year with AstraZeneca's Prilosec which was rebranded minus its inactive ingredient as Nexium just when Prilosec went generic.
Drug prices are often raised arbitrarily several times annually at rates well beyond inflation. In the five years before its patent ran out, Schering-Plough raised the price of Claritin thirteen times (a total increase of fifty percent).
Big pharma's perennial excuse for its high prices is that it needs the money for research and development (R&D). But, drug companies spend far more money on promoting their products than on research. Furthermore, most of the innovative research they do is at taxpayer expense. The taxpayer, however, gets no price break for this help.
Harvard University Senior Lecturer in Social Medicine Dr. Marcia Angell, who spent two decades at The New England Journal of Medicine and became its first female Editor-in-Chief, wrote "The Truth about the Drug Companies: How they deceive us and what to do about it" (Random House, 2005). In her article for The New York Review of Books (NYR) in 2004 preceding its release, she debunks the "We-need-the-money-for-R and D" myth.
"Of the seventy-eight drugs approved by the FDA in 2002," writes Dr. Angell, "only seventeen contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market."
Incidentally, none of the seven came from major US drug companies. As an example of these "me-too" drugs, Angell points out that we have six statins, all variants of the first.
Big pharma benefits greatly from the current system. For over two decades it was the most profitable industry in the US. In 2002, the combined profits for the ten Fortune-500 drug companies ($35.9 billion) exceeded profits of the other 490 companies combined ($33.7 billion). Big pharma dropped to third place in 2003 behind mining (crude oil production) and commercial banks. It is a global enterprise with roughly half of the companies based in Europe, though many have moved their R & D divisions to the US and with good reason.
Before the Bayh-Dole Act (1980), the fruits of taxpayer-funded research remained in the public domain for anyone to use. Bayh-Dole enabled universities and small businesses to patent discoveries funded by the National Institutes of Health (NIH) and to grant exclusive licenses to drug companies. NIH later was granted the right to enter into deals with drug companies directly. Other laws extended the life of brand-name drug patents, which increased from eight years in 1980 to 14 in 2000. The Medicare prescription drug benefit (enacted in 2003) forbids the government from negotiating prices with the industry.
Beyond stiffing the taxpayer, this has opened the door to serious ethical issues between big pharma and the medical community – especially medical schools and the major teaching hospitals. In Dr. Angell's article "Drug Companies and Doctors: a story of corruption" (NYR, January 15, 2009), she sites recent survey findings that about two thirds of academic medical centers hold equity in companies that sponsor research within their institutions. A study of medical school department chairs found that two thirds received departmental income from drug companies. Three fifths received personal income. Medical school guidelines regarding faculty conflicts of interest, where they exist, vary greatly and are permissive and loosely enforced, according to Angell.
"Indeed," Angell writes, "most doctors take money or gifts from drug companies in one way or another."
Angell estimates from annual reports of the top nine US drug companies that they spend tens of billions of dollars a year on physicians. She points out that physicians are given free meals and gifts. They are paid as consultants, speakers, ghost-authors of drug company papers and, "ostensible 'researchers' whose contribution often consists merely of putting their patients on a drug and transmitting some token information to the company."
Angell also states that big pharma subsidizes most professional organization meetings and most of the continuing medical education that physicians need to maintain state licenses.
"By such means," writes Angell, "the pharmaceutical industry has gained enormous control over how doctors evaluate and use its own products. Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease."
Professional and governmental bodies issue guidelines on the practice of medicine. Conflicts of interests have influenced these guidelines as well as FDA decisions.
Take cholesterol, for instance. Have you noticed that it is even harder to please your doctor nowadays than it was five years ago? In 2004, the recommendations for "bad" cholesterol levels were sharply lowered on the say-so of the nine-member panel of the National Cholesterol Education Program. Later, it was revealed that eight panel members had financial ties to cholesterol-lowering drug producers.
"In a survey of two hundred expert panels that issued practice guidelines," Angell's January article states, "one third of the panel members acknowledged that they had some financial interest in the drugs they considere."
Prescription Drug Ads: Understanding the Numbers and Taking Your Chances
My favorite example of the marginal efficacy of modern medications comes from a TV ad for Abilify, an antipsychotic initially approved for schizophrenia and bipolar disorder. Nowadays, it is marketed as a supplement to antidepressants such as Prozac. The ad claims – and no one has stepped forward to challenge the point – that approximately two thirds of patients being treated for depression still have symptoms of depression. What does that say about antidepressants?
New drugs are marketed to potential patients via expensive, ubiquitous and affective advertising campaigns – a practice long since abandoned by the rest of the world. One of the major problems with the marketing of medications is that statistics are used in ways, which although technically accurate, are grossly misleading. A drug can claim to reduce your risk for this or that condition by 50 percent. But, this doesn't address what your risk is to begin with. For instance, if a study shows that after one year, only 2 percent of the control group develops warts on their left ears, and that only 1 percent of the treated group gets them, the relative risk reduction is 50 percent. A more accurate approach would be to use either absolute risk or the number needed to treat (NNT).
The absolute risk reduction is determined by subtracting the percentage of the treated group who get the condition from that of the control group. In our example it's 1 percent. Advertisers, of course, would rather use 50 percent, and no law mandates that they explain that this is "relative" not "absolute" risk.
The NNT, which can be difficult to find and interpret, expresses how many people would have to be treated with a drug for a specific time to prevent one occurrence of a negative result. In our example, the NNT would be 100; i.e. 100 people would need to be treated for a year to prevent one person from developing a wart on their left ear. 99 people would be exposed to the risks of the drug with no possibility of a benefit. If you knew that ahead of time, how sure would you be that you were that one in a hundred?
The lower the NNT, the better. A drug which prevents all occurrences of left-ear warts would have an NNT of 1, since everyone treated would have wartless left ears. Everyone would know that, although they would be exposed to the possibility of negative side effects, at least they could be sure that the drug would work.
No one expects that kind of success, but, modern medications are far less effective than what you might think, if you're relying on the ads. For example, one condition which is garnering more and more concern among women is osteoporosis (brittle bones). It's a disease which is only a problem in some of the wealthiest nations. Even where bone density is low, fractures are not the issue they are in the U.S.
The article "Drug therapies for osteoporosis and osteopenia" was originally published by Women to Women in 2005 and was last modified in August, 2009. Researcher Dr. Susan E. Brown, PhD, who has studied bone health for over 25 years, explains how osteoporosis drugs called bisphosphonates work and their side effects. This class of drugs includes Fosamax, Actonel and Boniva. Brown discusses how statistics are manipulated by big pharma to alarm the public about the prevalence of the disease, exaggerate the benefits of the drugs and minimize the risks. She states that in 2006, $2 billion was spent promoting Fosamax alone.
"In fact," Brown writes, "these drugs are not recommended at all for primary prevention, yet women who are not at elevated risk for fracture are among the largest target audience of direct-to-consumer advertising for bone drugs."
Brown disagrees with the practice of comparing bone density test results for older women with those for 25-year-olds rather than with others in their age group. She also explains that the increases in bone density using DEXA scans are not an accurate indication of bone strength. Drug ads emphasize the dramatic changes many women experience in their scan results within the first year of treatment. These results, however, are misleading, because they are due to a lag in how the drugs affect the natural system of building up and breaking down bones.
"Like the process of bone resorption," she writes, "bone formation will eventually stop when on a bisphosphonate. Though the exact mechanism of action isn´t known at this time, we know that osteoblasts (our bone-builder cells) are inhibited by bisphosphonates. Research shows that after the first year, markers for bone turnover — growth and resorption — go down dramatically. So bone is neither building up nor breaking down once you´ve been taking a bisphosphonate for more than a year or so."
There is growing evidence that long-term (over 5 years) use of bisphosphonates actually weakens bones, causing rather than preventing fractures. Brown laments that the drug ads don't present an accurate picture of the benefits, which she sees as marginal, or the risks such as ulcers of the esophagus, fractures of the femur, bone pain, low blood calcium, irregular heartbeat and jaw bone decay. Drug companies are capitalizing on the growing number of older Americans, advancing a view of the risk which is inaccurate in order to sell a marginally effective product, according to Brown.
"In fact," she writes, "this large, aging population is part of the reason it looks like osteoporosis has become an epidemic in this country. In reality, US hip fracture rates have gone down since the late 1960´s in women, and since the early 1990´s in men, despite an aging population. Because of the large number of aging Baby Boomers, the actual number of fractures can seem overwhelming, even though the rate is decreasing."
Brown points to a 2008 review of 40 years´ worth of data on more than 12,000 women using Fosamax. It shows that, "overall, there was a mere 1-2% absolute risk reduction."
She recommends lifestyle changes, pointing to the 2004 Surgeon General's Report on Bone Health and Osteoporosis. The report warns that Americans are making choices that weaken bones and recommends changes in diet, smoking, alcohol consumption and activity level as the primary tools to preserve bone health. Drug therapy is recommended only for those at high risk and as a supplement to the lifestyle guidelines, not a substitute for them. For more information on the report, visit:
http://www.surgeongeneral.gov/library/bonehealth/
Read Brown's recommendations on natural methods of maintaining bone health at:
http://www.womentowomen.com/bonehealth/osteoporosis-drugtherapy.aspx
Specific studies of osteoporosis drugs show different NNTs, but even the lowest of them – in studies of only the people with the most extreme risk – still leave the patient in a game of chance. Family Practice Notebook author Scott Moses, MD (a physician in Minnesota) lists NNTs for bisphosphonates. For the prevention of one hip fracture using a three-year treatment, the NNT for Actonel was 77. For Fosamax and Reclast, it was 91. He compares this to the NNT for those taking 800 units of Vitamin D daily -- 45. The numbers for vertebral fractures are a bit better. To prevent one vertebral fracture (again treating for three years), the NNT for Reclast was 13; Actonel, 15; Boniva, 20; Fosamax, 37.
When only those with the highest risk are included in the study, the numbers are more favorable. In the case of Fosamax, for instance, nine patients at extreme risk need to be treated for three years to prevent one vertebral fracture.
Osteoporosis is not the only condition being exploited this way. "Statins Effectively Prevent Coronary Artery Disease" published in the American Family Physician, February 15, 2006 is an overview of fourteen studies on statins (drugs like Lipitor which are used to lower cholesterol). The pooled studies encompassed over 90,000 people – mostly men. Approximately 21 percent had diabetes, and 54 percent had cardiovascular disease. The article reports that statins reduced cardiovascular deaths (3.4 versus 4.4 percent). In other words, 109 people need to be treated to prevent one death.
So, ask yourself, how likely are doctors to know the absolute risk or the NNT for the drugs they are prescribing? Do you think your doctors have the time to pour through hundreds of studies to get a good overview of the information that's out there on each drug? Or, are they more likely to rely on the information provided by the drug companies' sales representatives who regularly visit their offices? How much of a chance are you taking right now, and how big of a gambler are you willing to be?

