Manipulating medical study data: studies on new drugs and medical devices are being manipulated by their manufacturers through the use of flawed studies, in-pocket experts, and pressure on the FDA.
How It Works
Almost everyone is now aware of the fact that Celebrex and Vioxx, two prescription pain medications primarily intended to help arthritis sufferers, have recently come under tough scrutiny and were almost pulled from the market because their use substantially increases the risks of serious complications--such as heart attacks, strokes, and cardiovascular disorders.
However, how many people realize that the drugs' dangers were known about at least since 2001 and were not made public knowledge? Very few I'd bet.
In his book, Overdosed America, John Abramson, M.D., a member of the clinical faculty at Harvard Medical School, details what he calls the "misrepresentation of Celebrex and Vioxx." He also analyzes similar deceptions with many other drugs and medical procedures that are commonly used in healthcare today and shows how lowering the use of unnecessary and often dangerous drugs and procedures would lead to massive cost savings and better healthcare.
In the case of Celebrex and Vioxx, both drugs were promoted as being superior to commonly available, and much cheaper, alternatives--such as ibuprofen (Motrin, Advil), naproxen (Aleve), and diclofenac (Voltaren)--because they reduced the likelihood of serious but nonfatal stomach ulcers. Contrary to the impression one gets from advertisements promoting the two drugs, they have not been shown in studies to be more effective at reducing pain than the cheaper alternatives, and despite articles in prestigious medical publications that insinuate otherwise, they do not even reduce the likelihood of getting serious stomach ulcers.
An article in the Journal of the American Medical Association (JAMA) for September 13, 2000, analyzing Celebrex, and another in the New England Journal of Medicine (NEJM), analyzing Vioxx, presented findings that purported to show that Celebrex and Vioxx were less likely to cause serious gastrointestinal (GI) problems--such as bleeding ulcers or a perforation of the stomach--than the cheaper alternatives, and both were untrue.
The JAMA article discussed a study done on Celebrex, a study of over 8,000 people with rheumatoid and osteoarthritis. It compared the risks of taking Celebrex with those of taking ibuprofen and diclofenac. The article stated that Celebrex, when used for six months, effectively reduced the risks of ulcers and ulcer complications.
Similarly, the article in the NEJM reported on a Vioxx study that included over 8,000 people with rheumatoid arthritis: "Treatment with Vioxx ... 'resulted in significantly fewer clinically important [major] upper gastrointestinal events than did treatment with naproxen [Aleve].'"
Both articles essentially advocated for the drugs being scrutinized, influencing doctors to believe that both drugs were safer alternatives than their cheaper competitors and should be drugs of choice. In reality, neither was safer.
Upon investigating the drugs' studies himself, Dr. Abramson learned that Celebrex did not lower the risk of serious gastrointestinal complications as compared to the cheaper alternatives, and it appeared to increase other more serious complications by 11 percent "in all body systems combined." Vioxx fared even worse. In the study, only those people who were also taking steroids--which have complications of their own--had lower rates of serious gastrointestinal complications. Those not taking steroids did not see a significant reduction in GI complications.
On the other hand, Abramson noted an incredible jump in cardiovascular complications of those who took Vioxx: "The results of the [Vioxx Gastrointestinal Outcomes Research] study show that for every 100 people with a history of cardiovascular disease treated with Vioxx instead of naproxen [Aleve], there were between seven and 11 additional serious cardiovascular complications each year." (Emphasis in original.) And "overall, including GI, cardiovascular, and all other serious complications, the people who took Vioxx had 21 percent ... more complications that usually lead to hospitalization or death, than did the people who took naproxen."
This leads to the question: were the medical journals intentionally misleading? The answer to that question is that we don't know. It is known that only a portion of each study was sent to the journals by the pharmaceutical companies--in the case of Celebrex, only the information from the first six months of the study was sent (the part of the study that appeared to show that the drug worked as advertised), and in the case of the Vioxx study, the portion of the study showing the cardiovascular complications was left out.
As a result, according to Abramson, very expensive (and dangerous) drugs were heavily prescribed by doctors: "Vioxx costs $100 to $134 a month, compared with $18.99 a month for prescription naproxen, or $7.50 for over-the-counter naproxen." With both drugs being "among the top 10 selling drugs in the United States," they significantly added to the price of healthcare in the United States.
Laundry List of Deceit
Unfortunately, Dr. Abramson found that skewed studies and over-prescription of medications were not unusual.
The makers of a cholesterol-lowering statin drug called Pravachol claimed that it reduced strokes in patients by 19 percent. (Statin drugs decrease the amount of LDLs--bad cholesterol--and total cholesterol in the body.) But the study focused mainly on men, average age 62, who took aspirin daily (aspirin makes blood platelets less sticky, reducing the chance of a stroke), while in the populace-at-large, most stroke victims are women significantly older than 62 who don't take aspirin daily. In the study, all-told, patients over 70 using Pravachol actually "had 21 percent more strokes than patients given a placebo," and women in the study "experienced 26 percent more strokes than the women who were given a placebo." Even more importantly, the study showed that lowering total cholesterol increased the likelihood of a stroke.
A variety of statin drugs is also heavily prescribed for warding off heart attacks (coronary heart disease) through lowering LDLs in the body. One of these drugs, lovastatin (brand name Mevacor), was tested in the five-year Air Force/Texas Coronary Atherosclerosis Prevention Study, a study of 6,600 people middle-aged and older with slightly elevated LDLs and below normal HDLs, good cholesterol. The study ostensibly showed that people taking lovastatin had a 37 percent lower risk of heart disease than those who got a placebo. Of course, the report that detailed the results of the study failed to mention that "treatment with a statin drug did not decrease the overall mortality." The people taking lovastatin were indeed dying less of heart disease, but they were dying of other illnesses needing hospitalization at a much higher rate than those taking a placebo.
Another therapy program called hormone replacement therapy (HRT) was promoted as being a way to stave off the effects of aging and to lower the risk of cancer and heart disease in women. These claims weren't true either, again, though a major study--the Nurses Health Study--purported to show that HRT lowered mortality rates. This study, too, was skewed. As nurses, the members of the study were relatively wealthy and received more regular preventative healthcare than the average woman, making HRT seem much better than it was. A later randomized study showed that HRT increased by 15 percent the number of serious "adverse events," including breast cancer, heart attack, stroke, and blood clots. Yet another study, the Million Women Study in England, showed that women taking the hormones "had a 66 percent higher chance of get ting breast cancer (30 percent for those taking only estrogen, and 100 percent for those taking both estrogen and progestin) than the women who were not taking hormones."
Fosamax, a drug prescribed to prevent osteoporosis (hence preventing hip fractures) does somewhat as advertised and increases the density of the outside of women's bones, but it is relatively ineffective at preventing hip fractures: women "taking the drugs decreased their risk of hip fracture from 0.5 percent to 0.2 percent." When women with osteopenia, thinning bones, took Fosamax, "hip fractures actually went up 84 percent."
Defibrillators are regularly implanted in people with weak hearts to prevent fatal heart attacks by stopping "ventricular fibrillation (a rapidly fatal arrhythmia in which a heart's ventricular contractions become chaotic and ineffective)." The defibrillators do reduce fatal heart attacks owing to ventricular fibrillation, but they also substantially increase the number of people who have congestive heart failure.
In a study done that compared the drugs Prilosec and Nexium, which both function as acid blockers to help what is commonly referred to as acid reflux, Nexium was described as more effective than Prilosec; however, the dose of Nexium in the study was double the size of the dose of Prilosec, 40 mg versus 20 mg. The same company owns both patents, and the patent for Prilosec was running out, and so they wanted doctors to prescribe the expensive drug.
Dr. Abramson discovered many other similarly skewed studies, including those done on antidepressants, other painkillers, allergy medications, cancer treatments, other cardiac procedures, diabetes care, and blood pressure medicine--drugs and procedures that account for hundreds of billions in healthcare spending each year.
Because it's easy to see the role that pharmaceutical and medical device companies play in causing us to receive less-than-optimal healthcare, it's tempting to recommend strict government controls on those industries as a way to fix the problem, which is exactly what Dr. Abramson recommended in his book (that and advocating "universal" healthcare); but that is not the answer to the problem. It's worth noting here that whenever less-than-honest, biased information about new drugs and medical devices was passed along to doctors by medical journals or through company advertisements, the federal Food and Drug Administration watched quietly from the sidelines without public comment.
On its face, the recommendation that the federal government take more control of healthcare is not logical. In medical terms, one might say that this recommendation is comparable to trying to cure a symptom of a disease, rather than curing the disease itself. For instance, say one were to go to the doctor with a fever, and the doctor prescribed a tub of cool water as a cure. It makes sense until one thinks about it. If the patient's fever is caused by a case of malaria, the cool water would not make him well; the patient needs to have quinine prescribed to deal with the underlying cause of the fever. It's much the same here. Unless the root cause of the problem is addressed, its symptoms will keep resurfacing.
Dr. Abramson sees how the pharmaceutical and medical device companies have abused the system and assumes that if those companies are dealt with, the present crisis in healthcare will be remedied.
But the underlying "disease" is federal government involvement in healthcare. By removing the federal government from involvement in healthcare, the pharmaceutical and drug device companies would not be able to manipulate medical testing with impunity--as they do now. And as long as the government is involved in healthcare, lobbyists will always be presented with opportunities to have government lackeys do their bidding--debilitating American healthcare.
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|Title Annotation:||Food and Drug Administration|
|Publication:||The New American|
|Article Type:||Cover Story|
|Date:||Sep 5, 2005|
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