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Monday, October 26, 2015

How can we start coming up with new therapies that actually save money?

In the United States, biomedical research, including basic science and clinical studies, is paid for mainly by companies that expect to make money off of new discoveries. The government, through the National Institute of Health (NIH) funds a little over a quarter of it, but most of the money comes from drug and device manufacturers.

This means that interesting research that might result in breakthroughs that save patients money is unlikely to find funding. This is terrible. If gummy bears cured cancer, we might never find out about it. If anything that is easy to come by, from various sources, were to show promise therapeutically, we as US citizens would not be likely to find out about it through our own research.

Some examples:

1. Red yeast rice, a dietary supplement made of rice fermented with the fungus Monascus purpureus in a centuries old process, contains a widely marketed cholesterol medication (lovastatin) that is naturally produced by Monascus. The doses are high enough to reduce cholesterol significantly. The best study of this product was done in China, with an extract of the yeast rice, and showed that it reduced bad heart outcomes more than did lovastatin in clinical trials here. The FDA has banned red yeast rice periodically (though it is now easy to find online) saying that it could be dangerous. For awhile, the only red yeast rice products that could be sold in the US were ones which either didn't mention how much active ingredient they contained, or contained little to none of it. Now that we can buy it again, it is unclear which brands actually work to reduce cholesterol.

2. Aspirin, which was first widely adopted for treatment of pain and fever in the late 1800s, was found in the 1970's to be very effective for treating and preventing disorders due to blood clots, particularly heart attack and stroke. I wondered how, since this drug was widely available at a very low price, research had been done in the US to show how effective it was. It turns out that the groundbreaking work was done in Britain, where most research is funded by the government (which would stand to gain, along with patients, from discovering an inexpensive approach to a common problem.) To be fair, in the 1970's research in the US was much more often paid for by the government, so the aspirin research probably could have been done here.

3. Corticosteroids (prednisone and others) are widely available and inexpensive medications which reduce inflammation. They have various side effects and so are used sparingly in most situations. It turns out that, when used along with antibiotics in severe community acquired pneumonia, they make people improve faster and die less frequently. A review of 13 randomized controlled trials came out in the Annals of Internal Medicine earlier this month. Dr. Reed Siemieniuk was the first author. He and his coauthors are from Canada and Europe and the vast majority of the articles reviewed were done in Europe. Studies like this don't happen in the US because drug companies have no incentive to fund them. Full color, full page ads or TV infomercials will not tout the importance of this discovery, so it will be a little more difficult than it might be to change the habits of US physicians to incorporate this life and money saving approach.

4. Nicotinamide, also known as vitamin B3, a derivative of niacin, was just reported to reduce pre-cancerous skin spots, known as actinic keratoses. These are the little scaly spots that happen on the arms, heads and faces of aging people who have spent time in the sun. It also appears that topical nicotinamide may do the same thing, as well as reducing wrinkles and other signs of aging. This vitamin is available widely and costs pennies a pill. How could such research have been done, since this discovery will likely decrease the amount of money spent on other expensive treatments and prescription potions for this problem? It was done in Australia, funded by the National Health and Medical Research Council. Nicotinamide, though it is related to Niacin, does not cause flushing and does not reduce cholesterol levels, though it has reversed symptoms of Alzheimer's disease in an experimental mouse model.

What can we do in the US to re-purpose our considerable intellectual resources and vast research machinery away from increasingly complex and costly new technology and toward elegant and ingenious cost-saving approaches? In the big picture, we could figure out a way to move money that will likely be spent on useless or overly expensive healthcare toward research that leads to lower consumption of resources. The NIH in the US is the organization that can fund non-biased research, and is perfectly suited to doing so. Money spent on cost-saving technology will pay for itself many times over.

Drs. Arthur Kellermann and Nihar Desai, from Bethesda and Yale respectively, discuss in a recent JAMA article several specific recommendations from RAND health, a think-tank charged with improving global health and reducing costs. These include creating a public-interest investment group to fund good projects, giving cash prizes to inventors, buying out patents to allow reasonable pricing and reducing unnecessary regulatory hurdles. They conclude:
"Realigning incentives to encourage inventors and their investors to develop cost-lowering products could transform technology, which is currently one of the most potent drivers of health care spending in the United States, into a powerful creator of value. Once that is done, ingenuity will take care of the rest."

Sunday, October 18, 2015

Repatha and Praluent: VERY expensive drugs to lower cholesterol which may not actually work to prevent heart attacks (then again, perhaps they will.)

In July of 2015 the US Food and Drug Administration (FDA) approved an injectable monoclonal antibody alirocumab (Praluent) which lowers the LDL or "bad cholesterol". The drug is produced by Regeneron, given by injection once every 2 weeks, and will cost $14,600 wholesale per year. In August, evolocumab (Repatha) was FDA approved. It, too, is a monoclonal antibody and will cost $14,100 wholesale when it is finally released. It was developed and will be marketed by Amgen.

These drugs are antibodies, produced in hamster ovary cells in vats, which, when injected, bind to proprotein convertase subtilisin/kexin type 9 (PCSK9), making it less active. PCSK9 normally reduces the liver's ability to remove low density lipoprotein (LDL) from the blood. The main drug class that we have now which reduces LDL is the statins, also known as HMG CoA reductase inhibitors, which reduce the production of cholesterol. A couple of common statins are atorvastatin (Lipitor) and simvastatin (zocor.) I have ranted about them copiously in the past.

The reason we worry about LDL is that high levels of it seem to be associated with heart attacks and strokes, and people with a genetic defect that raises their LDL to very high levels often die young of heart attacks. There are many drugs which can lower the LDL levels, but the statins work best and also have been shown to reduce the risk of heart attacks and strokes in high risk patients. The studies are less clear about their benefits for lower risk people. Many drugs which lower the LDL do not reduce the risk of strokes or heart attacks, and it may be that statins have positive effects due to their reduction of inflammation or some other positive effect on blood vessels.

In 2013, recommendations from the American Heart Association and the American College of Cardiology changed from recommending using medications to lower cholesterol below certain levels, depending on level of risk, using diet and medications, to simply using statins for everyone at elevated risk of vascular disease, such as heart attack or stroke. Statins don't appeal to everyone, primarily due to side effects of muscle pain and weakness, also sometimes problems with thinking and memory, so this approach is not universally applicable. But with statins now mostly generic, this approach costs only about $150 per year and is pretty effective.

There is another problem with this approach (besides the fact that it puts huge numbers of people who might never have trouble with vascular disease on a statin drug with unclear long term side effects). There is no room in these statin-based recommendations for non-statin drugs, especially absurdly expensive ones that were finally released after more than 10 years of research by powerful drug companies.

The PCSK9 drugs have been approved for use in patients with familial high cholesterol syndromes and those with known disease of the coronary arteries whose cholesterol remains high despite statins. Insurance companies and anyone else with concerns about rising medical costs are concerned that doctors will start prescribing these drugs with gay abandon to everyone whose cholesterol worries them, with a multi-billion dollar impact on health care costs. The drug companies promise to provide the drugs for less money to patients who can't afford them and to cut deals with insurance companies, but the costs may still be staggering.

In the last two days I saw two articles suggesting that we start to obsess about cholesterol levels again, shifting away from the recently accepted approach of simply treating everyone at high risk of heart disease with statins. The first, in JAMA, was authored by 3 physicians employed by the healthcare company CVS, saying that if we don't start checking LDL levels and targeting higher ones for treatment, anyone with very high risk will be put on PCSK9 injections. CVS, as a pharmacy benefit management company, stands to lose money if patients' drug bills go up astronomically. Then again, they might pass the costs on to consumers and manage to make money. Plus CVS sells point of care cholesterol blood tests, so I'm not sure where their interests lie.

The second was an "educational activity" presented by Medscape, featuring a discussion by 3 physicians with academic affiliations (two from Harvard Medical School) who would all like to go back to checking LDL levels and using medications to get the LDL as low as possible so as to reduce the risk of heart attacks. The activity was financed by Regeneron and Sanofi, who make the new injectable super expensive cholesterol drug, and all of the experts have been on the payrolls of one or both of the companies that produce these drugs. They are very excited about how well these new drugs lower the LDL, and they expect that when studies come out looking at reducing risk of heart attacks they will actually have some clinical benefit. They talk about how many patients might be "candidates" for this therapy, as if it's some kind of a sought after political office. That part is just plain creepy.

There are so many problems with all of this. First and most importantly, we don't know if these super expensive drugs actually reduce the risk of heart attacks. We won't know until 2017, when the first of the many studies which are ongoing will be available. It doesn't matter at all if they lower LDL levels, since high LDL levels aren't actually a sickness. The excitement about this new drug will again focus us away from the fact that lifestyle changes such as quitting smoking and becoming at least moderately active are even more effective in reducing risk for all kinds of vascular disease and other miseries than any medication we have produced. It's very likely that patients who continue to smoke and abuse their bodies in other ways will be put on these drugs, because those are the patients who are at highest risk of heart disease. Do we really want to be directing resources in this direction?

And what about the cost? Why $14,600 per year? What a crazy number. Probably we should just shelve it until we know if it works, then, if it does, figure out who actually needs it.

Friday, October 2, 2015

Medical bills: why are these completely inscrutable and full of mistakes?

Within the last two days I received a bill for my glasses and read a post by a friend ranting about medical billing mistakes. This is a huge problem that is so common that it could be considered the norm. It is ridiculously expensive and could probably be fixed.

My exposure to medical bills has been through patients who show them to me, hoping I can make sense of them, my occasional foray into the world of being a healthcare consumer and the woes of friends and family. I can say, with confidence, that I have never read a medical bill that I understood. When I do choose to dig a bit deeper, overcharging and errors are more common than not.

It is very hard to get good statistics on this, but the lower end of what I'm seeing suggests that one in 10 bills contain errors. It's probably higher than that.

Common billing errors include being billed for procedures that were cancelled, being billed twice for the same thing, under different names, being billed for a more complex version of what was actually done and being billed for more time than was actually spent. How do these happen? In general the errors aren't deliberate fraud. Frequently staff in the billing office do not talk to doctors but produce bills based on what the doctors write. Doctors don't document what happened right away if they are busy and so by the time they do make a note, details are often fuzzy. In the case of billing for canceled procedures, the only paper trail available to billers may be the order for the test, and the cancellation may have been communicated by voice, on the fly. When doctors do bill for themselves, it may be difficult to find the correct code, so, in a hurry, we just settle on the first one that resembles what we did. Most of us are not interested in getting better at billing because we hate it. We weren't trained to do it and it takes us away from patient care.

Patients often (but certainly not always) know what did happen. Their bills, though, are written in some long forgotten Martian dialect which makes it really difficult to correct the errors.

My bill for glasses, which turns out to have been correct (after two phone calls) is a good example of what is wrong with medical bills. I apparently owed $137 for "lens sphcyl bifocal 4.00d/0.1, and $155 for "progressive lens per lens" and also more money for "lens polycar or equal" (which I would have assumed was my lens sphcyl, but I guess not), also the anti reflective coating and a miscellaneous vision service and a miscellaneous product which apparently meant that they charged to drill a hole in the lens and polish it. Sales tax I could figure out on my own. Also the bill didn't say anything about insurance, which does pay some portion, and the biller was not planning to submit it. A separate bill has arrived detailing the cost for my exam, also written in some language that I don't speak. The bills are dated a week apart, for unclear reasons. Theoretically I should be pretty well positioned to understand this sort of thing, after 3 decades in the medical field. I'm guessing others, who might be less educated, sicker, more fatigued or less assertive would simply give up and not check the bill at all.

My friend's issue was being billed for copays that he actually paid at the time of service, then getting notices that he was delinquent for not paying them, having to call the billing office multiple times and eventually having to appear in person in order to get it fixed.

Because billing in excess of services usually leads to making more money, there is no real economic incentive to do this right. A responsive and intelligent problem solver in the billing office may actually lose the practice money, if he or she uses the relevant skills to solve customer complaints. The only economic reason to reduce inadvertent overbilling is to avoid being caught and penalized by insurance companies. There are definitely medical billing specialists who delight in doing their jobs accurately, but there is no cash reward for this sort of behavior.

The most effective first step toward taking care of the problem would be a requirement (it could even be a law) that medical bills be descriptive enough that regular people can actually understand them. The affordable care act made health insurance companies describe their services in ways that average people could know what they were buying. If people could actually read and understand their bills, they could see if they were correct. We could even tack on to the law a time limit for resolution of a query. Wouldn't it be sweet if a billing question would be fielded in 24 hours and resolved in a week? That doesn't sound too difficult.

The whole issue of medical billing is, of course, wrong in a very big way, since its existence is based on fee for service. As long as providers can make more money for doing more things and more complex and difficult things, their will be economic pressure to do more intense medicine on more people, thus creating more people who have been medicalized into being sick. We do, though, have fee for service medicine at present, so it's time to support the (not yet written) "Medical Bill
Clarity Act of 2015."