Our Chicago medical malpractice attorneys are, unfortunately, not shocked to learn that yet another class of drugs has been over-marketed and over-prescribed, to the financial benefit of the pharmaceutical companies and the harm of patients and the general public. This time it is statins that we have learned have been unnecessarily prescribed to millions of patients, causing untold harm. This overuse, and the marketing that led to it, trigger viable medical malpractice and products liability claims.
These drugs are marketed under a wide variety of brand names, the most commonly known of which include Lipitor, Crestor, Zocor, Pravachol, and Mevacor. They work by lowering a patient’s LDL, the so-called “bad cholesterol.” Statins can reduce fatty deposits in a patient’s blood, and may also reduce inflammation, which leads to plaque deposits breaking away from the walls of blood vessels, causing blocked arteries: heart attack or stroke. The problem, however, is that no one – not even our nations top research physicians – really understands the relationship between bad cholesterol, inflammation, and heart disease.
Statins arrived on the U.S. scene in 1997. They are now the world’s most prescribed medications. In the United States alone, about 24 million – that’s right, million – people take these drugs. At one time, these drugs were earning manufacturers over $26 billion dollars a year. That figure has dropped slightly, as statins are now available in generic form. The availability of generics, however, and the corresponding availability of cheaper versions of these medicines, has only increased the number of people using them. In 2009, the number of statin prescriptions filled in the U.S. was double that of prescriptions filled in 2001.
This class of medications was originally approved by the Food and Drug Administration for “secondary prevention,” or use in patients who had already suffered a heart attack or stroke – used to prevent recurring attacks.
But the rampant increase in use has been driven by “primary prevention,” the notion that statins should be used in patients who are otherwise healthy, but have high levels of LDL cholesterol. These primary prevention patients make up the majority of those on statins today – and it is these patients who are being placed at an unnecessary risk at risk, and may have valid medical malpractice or product liability claims in the future.
The latest round of the debate over statins appeared in late June in the Archives of Internal Medicine. The Journal published three studies, each looking at whether statins are all that they are cracked up to be. The first found that statins do not lower death rates among primary prevention patients. The second cast doubt on a key study used to justify primary prevention prescriptions. The third looked at the many conflicts of interest – ethical, clinical, and financial – that were present in that same study. Indeed, the principal researcher in that influential study (the JUPITER trial) had millions of dollars in royalties on the line. Our Chicago products liability attorneys believe that it will not be long before one – or many – class action suits are filed against the doctors and companies who conducted the JUPITER trial.
Conflicts of interest are simply at the heart of the booming popularity of statins. Indeed, primary prevention use skyrocketed after 2001, the year in which the National Heart, Blood and Lung Institute adopted guidelines calling for primary prevention prescriptions for as many as 36 million Americans with elevated cholesterol. But the National Institutes of Health has now acknowledged that of the nine physicians involved in crafting these guidelines, eight had “substantial financial ties” to drug companies that manufacture statins.
This over-prescription is not simply an academic matter: the side effects of statins, which untold numbers of Americans have suffered unnecessarily, are many and varied. At the tolerable end, the most common side effect of statins is simply muscle aches. Although this side effect is mild, somewhere between 5% and 20% of statin patient experience this effect. Some patient also experience headache, nausea, sleep disturbances, weakness, joint pain, memory loss, and diarrhea. Other side effects are not so manageable: tendon problems, depression, sexual dysfunction, peripheral neuropathy, and cataracts.
Then there are the larger problems: pancreatitis, osteoporosis, hemorrhagic stroke, even interstitial lung disease. Additionally, statins can cause muscles to actually break down, releasing a substance that damages the kidneys. They can also increase a patients liver enzymes. This particular effect is so common and serious that all statin patients are advised to have liver function tests after starting the medication and every year thereafter. Shockingly, if the increase in liver enzymes is present but low, the patient is often advised to remain on the medicine. But this increase can lead to permanent, irreversible liver damage. Frighteningly, Dr. James M. Wright of the University of British Columbia in Vancouver, sums up our understanding of the effects of statins with this statement: “I don’t think we know all the harms yet.”
In the face of the statin craze, true experts continue to remind us that the best way to prevent heart disease, heart attack, and stroke is to exercise, refrain from smoking and excessive drinking, and eat a healthy “Mediterranean” diet. Perhaps the problem was best summarized by Dr. John Abramson of Harvard Medical School, a vocal critic of the over-prescription of statins. “There’s a conspiracy of false hope. The public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.” Indeed, the drug companies have sought every avenue to increase the use of statins, testing their effectiveness (with negative results) on everything from Alzheimer’s and rheumatoid arthritis to prostate and breast cancer, from kidney disease to macular degeneration and even diabetic neuropathy
It is important to note that these new studies do not call into question the effectiveness of statins for those who have already had a heart attack. For those patients, statins are a proven and effective weapon for fighting off additional attacks.
For a free consultation with an experienced Chicago medical malpractice lawyer at Passen & Powell, call us at (312) 527-4500.