Showing posts with label Vioxx. Show all posts
Showing posts with label Vioxx. Show all posts

Friday, August 30, 2019

Some medical care may not help. Alternatives may not either.


‘Why Doctors Still Offer Treatments That May Not Help’, by Austin Frakt in the New York Times, August 27, 2019, is a well-done article that, despite its title, is fairly optimistic. He reports that while about 50% of current medical treatments no not have good evidence supporting them, only 3% have evidence showing them to be harmful, and another 6% unlikely to be helpful. This means about 41% (or only 41%, if you prefer) have good evidence that they are helpful.

Frakt cites some of the research on health interventions that do not work, or may even harm, quoting leading researchers Vinay Prasad and Adam Cifu (although he does not mention John Ionannidis, arguably the father of the field). He discusses the important “Choosing Wisely” campaign, initiated by the American Board of Internal Medicine Foundation, that asks each medical specialty society to identify at least 5 things often done in their specialty which usually should not be done. There is not, however, always consensus. For example, among its 20 recommendations (a high number that continues to grow, perhaps because of its discipline’s broad scope), the American Academy of Family Physicians (AAFP) recommends against imaging (including MRI and CT) for uncomplicated back pain, as does the American College of Physicians (Internal Medicine) (seeMedicine should not be primarily a business: choosing appropriate care for all, not excess testing for some, August 19, 2018).  Yet, neither the American Academy of Orthopaedic Surgeons, or the various groups of radiologists who perform these procedures, make this recommendation. Of course, both stand to benefit financially from doing these procedures.

It is concerning to think that, at least in some cases, financial benefit may influence the selection of some medical societies’ “Choosing Wisely” recommendations. Sadly, it is not a surprise, and financial benefit is, I believe, the reason for the use of many unproven treatments. Another important reason is an understandable reluctance for providers to abandon therapies that they have used for many years and believe to be successful. After all, if 50% of treatments do not have good evidence that they help or harm, many probably often do help, even if most of the evidence is anecdotal. Much more malicious, however, is the intensive marketing of new drugs and therapies to physicians by drug and device makers with a strong financial profit motive.

Frakt provides a litany of therapies-since-found-not-to-work-or-even-do-harm, including hormone replacement for post-menopausal women. The only drug he specifically names is Vioxx®, the “miracle” anti-inflammatory pulled from the market when it was found to cause heart disease (at least publicly found; the manufacturer actually knew it before it was released!). He also mentions “tight blood sugar control in critically ill patients” (and actually, probably most patients). This certainly relates to drug. The plethora of new, expensive, and marginally advantageous diabetes drugs is a testimony to their profitability. Ironically, it is often the same physicians who are unwilling to give up on treatments that are unproven or even proven to be of no benefit or of harm who are the first to begin using new (and, redundantly) more expensive drugs heavily promoted by the manufacturers.

Of course, it is not just diabetes drugs that are expensive. Compared to some of the newer drugs for rare diseases they seem like a bargain. In “The $6 million drug claim”, Times writers Katie Thomas and Reed Abelson discuss a woman who has $1 million in drugs to treat her condition in her refrigerator! While in her case they were paid for by her husband’s union, the cost can still be backbreaking: “At one point in 2018, for every hour that one of the union’s 16,000 members worked, 35 cents of his or her pay went to Alexion to cover the Pattersons’ prescriptions.” And what about those who have poor insurance, or no insurance? Or a union that goes bankrupt paying for them? Alexion, of course, does well, though.

A new law allows “gravely ill” patients the “right to try” drugs that the FDA has not approved. It sounds good; as a friend told me “I figure if I’m going out and they want to try something that might kill me I haven’t got much to lose. At best I’m cured. At worse, I go out but knowledge is gained.” Except for maybe dying sooner or more painfully, or possibly going bankrupt. It is not uncommon for doctors to suggest something new, unproven, or even a treatment that has already failed, one more time. Not everyone in this country has good insurance, and if your insurance company appropriately refuses to pay because there is no evidence of efficacy (yes, they are sometimes right!), you are on the hook for the bill. You may be dying, but your family may need the money you were saving for retirement. Thus, there may be a great deal to lose.

A certain percentage of people will take all this to mean that mainstream medicine is not to be trusted. This is definitely an overreaction, although a healthy skepticism is warranted, especially when the treatment is incredibly expensive and it is obvious that somebody (or some corporation) is making a killing on it. Some people will decide to pursue only what used to be called “alternative” medicine. These practices, often with hundreds or thousands of years of experience, are often called “complementary” and are now frequently offered along with mainstream medical therapies in “integrative” practices. But the same cautions must apply; because something is different, or traditional, does not make it necessarily either effective or safe.

For example, while people sometimes believe it is safer to choose only “natural” medicine, because a therapy grows in nature does not mean it is necessarily safe. Earlier in my career, medicine virtually abandoned the use of digitalis, made from the natural plant foxglove, to treat heart disease, after it had been used for decades. The key point is that if a substance works biologically and has “good” (i.e., desired) effects it can also have “bad” (i.e., undesired, or “side”, effects). This is true if it is straight from the plant, modified and standardized, or completely created in the laboratory.

Another real danger is what Frakt calls “wishful thinking”. Being optimistic and hoping that things will turn out well is good, and often useful when confronting serious illness. But when this transitions into the realm of “magical thinking”, being convinced that something good will happen to you because you want it to (or vice versa, that something bad will not happen because you don’t want it to), or believing a treatment will work because it is “natural”, or because your doctor recommended it in the absence of evidence, it is a real risk. “Magical thinking” is normal in three year olds, but dangerous in adults.

So what to do? Be open to new treatments, but do not reject the old, whether “traditional” or medical. Ask for evidence for treatment, such as when just changing a drug from an inexpensive standard (say, metformin for diabetes) to a new, costly one. Learn to understand probability, and ask for numbers. Do not reject anything out of hand, but do not believe that something will work just because you want it to.

Stay skeptical but not intransigent. Look for the evidence. And look also, when something is expensive, for the profit motive. Cui bono? It may not always be you.

Thursday, May 22, 2014

Treatments that don't cure the disease; we are spending money on the wrong things

In “Heralded treatments often fail to live up to their promise” (Kansas City Star, May 17, 2014), Alan Bavley, writing with Scott Canon, continues to demonstrate that he is one of the excellent health journalists – excellent journalists – in the US, along with Elisabeth Rosenthal of the New York Times. The common practice in the news media (and, thanks to a typo, “medica”) is to hype the new, exciting, dramatic, expensive, and hard to believe even though you want to. In politics, we often see the media acting as flaks for the government, the rich, and the powerful (sometimes, of course, these can be in conflict). Bavley and Rosenthal  and their ilk actually do investigative journalism, trying to the best of their ability to find out the truth rather than to reprint press releases.

The article begins with a review of a surgical procedure that was designed to control high blood pressure (hypertension) without drugs, by cutting some of the nerves to the kidneys. It made sense, it was seen as a big breakthrough (“The potential benefit was huge,” said a cardiologist). Unfortunately, when actually subjected to appropriate scientific study, it didn’t work. Or, rather, it worked just as well as placebo, a sham surgical procedure. The same cardiologist remarks ““This could be considered the biggest disappointment in cardiology of this century, but “the medical community went about it right.” 

Science worked. Unfortunately, the authors add,
“If only that were always the case. A combination of industry marketing, overly eager doctors, demanding patients and news media ready to cheer on anything that sounds like a breakthrough is popularizing many drugs, surgeries and other treatments long before they’re adequately tested. Far too often, they’re ultimately proved ineffective, no better than older, cheaper therapies, or even hazardous. Billions of dollars are wasted and tens of millions of patients are put at risk”

Yup. They go on to cite the Vioxx scandal, in which Merck concealed evidence of its biggest-selling drug causing an increase in heart disease. But that was taken off the market; many other unproven (or worse, proven to be ineffective) treatments are not. They talk about arthroscopic knee surgery, still often being done for conditions for which it has been shown to be no more effective than a sham procedure. They discuss surgical robots, costing upwards of $1.5 million, and proton-beam radiation treatments (those babies, the machines, really cost a lot!) for which the evidence of effectiveness compared to more standard and much cheaper treatment is mixed, at best. But hey, if you’re a hospital, and the competition has robots and proton-beam accelerators, who’s going to come to you if you don’t have one? Poor people? Heaven forfend!

And it is all about getting the advantage on the competition to make more money. A good argument can, and should, be made that competition in hospitals helps no one. That if there were an expensive item that there were an actual medical need for one of in the community, there should be one, not one at every hospital. But that would presume that the goal of the health system was to increase the health of the American people at the lowest effective cost. It isn’t. It’s to make money. If I can get your patients to come to me instead, it is seen as a victory (from a competitive business sense). It is really a loss for the health of our people and the pocketbooks of us all.

It is particularly depressing because that money is not buying us health. If you still harbored the belief that “we have the best health care system in the world”, it’s time to acknowledge that you are wrong (although we forgive you given the hype!). We should all know how expensive our health care system is, that we spend way more than any of the other developed countries (members of the Organization for Economic Cooperation and Development, OECD). The attached graph, from Steven Woolf, MD, PhD, who was a plenary speaker at the recent Society of Teachers of Family Medicine Annual Conference, shows a comparison of spending and life expectancy for the OECD countries. That’s the US way off to the right, spending more than anyone by far, but having a life expectancy close to the Czech Republic. Better than Mexico, Poland, Slovakia, Hungary and Turkey, but at enormously greater cost!

Woolf was the lead author of the Institute of Medicine’s (IOM) recent report “Shorter Lives, Poorer Health” , which presents depressing, but unfortunately accurate, data on our health status. We are among the “leaders” in death rates from communicable and non-communicable diseases and from injuries. Only for a few causes are our death rates better than the average. Our life expectancy at birth is worse than any of the 17 comparison countries for men, and second worst for women. Our probability of survival to age 50 is lower than any of 21 comparison countries. At any age until 75, we are never better than 15 out of 17 in terms of life expectancy. We do have better survival rates once we reach age 75, but there is no information on how much of that is keeping people alive despite poor quality of life.

Want more? In case you think it is only the minority populations (although that would be part of our population), non-Hispanic whites rank no higher than 16 of 17 at any age below 55. And the only portion of our population for whom mortality rates have risen is non-Hispanic whites with less than 12 years of education. From 2005-2009, the US had the highest infant mortality rate of the 17 countries and the 31st highest in the OECD. Non-Hispanic whites and mothers with 16+ years of education also have higher infant mortality rates than those in other countries. Among the 17 peer countries, mortality from transport accidents decreased by 42% in the OECD between 1995 and 2009, but by only 11% in the US. The same trends hold for child and adolescent health – and ill-health and mortality.

And then there are the areas where we really shine, particularly health issues related to guns.
  • In 2007, 69% of US homicides (73% of homicides before age 50) involved firearms, compared with 26% in peer countries.
  • A 2003 study found that the US homicide rate was 7 times higher (the rate of firearm homicides was 20 times higher) than in 22 OECD countries.
  • Although US suicide rates were lower than in those countries, firearm suicide rates were 6 times higher.

We have the highest child poverty rates in the OECD, our preschool enrollment is below most countries, and the ratio of social services spending to medical spending is below almost all other OECD countries.

This is insanity. We are spending enormous amounts of money, but we are spending it so that our hospitals can compete with each other, so that we can deliver the most expensive and high-tech care whether it benefits people’s health or not, and we then do not have any money left to do the things that would really enhance health: expanding education, creating jobs, decreasing poverty, ensuring that people had homes and enough to eat.

Not to mention the guns.


Total Pageviews