Tag: drug

Public Policy Puts Health at Risk

In my last post I expressed concerns about healthcare. The concerns have only worsened. This is only some of the issues, and almost every day I put off finishing this article something else would come along.

  • PEPFAR – On the first day of his second term President Trump cancelled funding for PEPFAR ? Between 2003, when the program was signed into law, until 2024, it’s credited with saving about 25 million lives. AIDS was fatal for almost everyone who was infected with HIV forty years ago but starting in the 1990s treatments became available that turned it into a manageable chronic disease. It’s estimated that 20 million people had their treatment cut off without warning. Such a system of care cannot just be replaced immediately, even if there was another source of funding. In just South Africa alone it was calculated that the funding cut would lead to 565,000 new infections, life expectancy would decrease by 3.71 years, and deaths would increase by 38%. Not only might we have up to a million people die per year from untreated HIV, interrupting treatment increases the risk of developing drug resistant HIV, and that can spread to the whole world. The United Nations agency that fights HIV announced they are cutting their employee count in half due to funding cuts, with the U.S. funding 40% of their activities in 2023. They estimated that if funding is not restored more than 6 million additional people could die from AIDS in the next 4 years, and an additional 2,000 people a day could become infected with HIV. Just in the US it can end up costing more than we saved by the funding cuts, not to mention the inhumanity of it.
  • Food Safety Checks – According to the U.S. Public Interest Research Group Education Fund there was a 41% increase in food recalls for possible contamination by E. coli, salmonella, and listeria in 2024 compared with 2023. Food born illness increased by 20% and related hospitalizations and death double. But as a result of staff cuts at the Department of Health and Human Services, the Food and Drug Administration (FDA) has suspended its quality control program for food testing laboratories.
  • Food Security – The government agency responsible for running Meals on Wheels, among other things, is being dismantled by Health Secretary Robert F. Kennedy Jr. It also funds programs at senior centers and independent living.
  • Withholding Research Funds – The Department of Health and Human Services announced that they were going to cut funding for the Women’s Health Initiative, a ground breaking study that has been ongoing since 1990 and that has been following tens of thousands of women. Fortunately they reversed their decision a day later after a loud outcry. The National Institute of Health (NIH) had funded research on almost every drug on the market here. They announced they would invest $500 million dollars to study a universal vaccine using old, traditional technology. This will come at the expense of research on mRNA vaccines, which created the highly successful COVID-19 vaccines. This technology allows vaccines to be made much more quickly, important for future pandemics, and has been shown to increase survival in pancreatic cancer, an may cure chronic and genetic diseases, such as Type 1 diabetes and multiple sclerosis.
  • Preventive Health Research – Despite Robert F Kennedy Jr proclaiming he would Make America Healthy Again, President Trump recently proposed cutting the budget almost in half for the Centers for Disease Control and Prevention. Last month 2400 jobs were cut from the National Center for Chronic Disease Prevention and Health Promotion. That includes programs for lead poisoning prevention, HIV, firearm injuries, smoking cessation, preventing cancer, heart disease, diabetes, Alzheimer’s, epilepsy and Alzheimer’s disease, and for states to deal with public emergencies and things like blood pressure screening. The proposed budget would also cut the Eliminating the Office on Smoking and Health. It’s hard to see how that will make use more healthy.
  • Infection Control – The Trump administration shut down the Healthcare Infection Control Advisory Committee (HICPAC) that helps set national standards on controlling infections in hospitals, including hand washing, mask use, and isolating sick patients. The current recommendations date back to 2007 and an update was being prepared.
  • World Health Organization – President Trump issued and executive order withdrawing the United States from the WHO. It takes year for it to be fully implemented, given that countries have to give notice first, and it could be reversed by congress, but this will hurt global health and can affect us in the event of another pandemic or other medical issues.
  • Measles – Thanks to low vaccination rates we are experiencing a measles outbreak. There have been over 880 cases in the US this year as of late April. Two doses of MMR vaccine is 97% effective in preventing measles, and we need at least 95% of people to be vaccinated to prevent additional outbreaks. Yet in the 2023-24 school year only 92.7% of kindergartners were vaccinated. If that rate persists it’s estimated we’d have more than 850,000 cases in the next 25 years. If it drops 10% more then we could expect more than 11 million cases in the next 25 years. But if we increased the rate by 5% then we’d only have about 5,800 cases in that same period. That should be a no brainer, yet Robert F Kennedy Jr has only given lip service to promoting vaccination and has talked about the value of vitamin A and other non-effective treatments.
  • Silicosis – This is a deadly lung disease that affects people who work with silicon, including miners and people who fabricate and install artificial-stone kitchen countertops. From closing Occupational Safety and Health Administration (OSHA) and Mine Safety and Health Administration (MSHA) offices, to firing Coal Workers Health Surveillance Program (CWHSP) and National Institute for Occupational Safety and Health (NIOSH) staff, more people will develop silicosis, and they won’t get diagnosed until their disease has progressed even more, if they get diagnosed at all.
  • Surgeon General – After withdrawing his initial nomination for surgeon general due to her providing misleading or incorrect credentials, he has nominated Dr. Casey Means, despite that she has not compleated a residency, sells supplements on her website, and has expressed vaccine skepticism. For a position that oversees the U.S. Public Health Service (USPHS) Commissioned Corps and provides “Americans with the best scientific information available on how to improve their health and reduce the risk of illness and injury,” we can do better.
  • Opioid Drug Deaths – At the same time the CDC announced significant progress is decreasing drug overdose deaths, their opioid surveillance programs may get a $30 million funding cut per preliminary budget reports.
  • PFAS – The Environmental Protection Agency (EPA) announced that they will be scaling back rules on limiting some PFAS, or per- and polyfluoroalkyl substances, virtually indestructible chemicals, in drinking water. They are associated with some cancers, decreased fertility, developmental delay in children, and metabolic disorders. It doesn’t sound like the EPA is protecting the environment.

One small positive is that the Agriculture Department is fast-tracking state requests to remove candy and soda pop from coverage under the Supplemental Nutrition Assistance Program (SNAP), otherwise know as food stamps.

RSV(P)

Respiratory syncytial virus (RSV) is a virus you may never have heard about, but you’ve probably had. It affects the upper airways with cold like symptoms, but it can cause a severe pneumonia, particularly in infants, older adults, and those with lung disease, or who are immunocompromised. By two years old almost all children have been infected. It causes roughly 2/3 of the number of hospitalizations and deaths as that cause by influenza (the flu). It tends to peak around the same time as influenza and COVID-19, constituting a triple threat.

There is a monoclonal antibody for infants and young children, but this year for the first time adults 60 and older can get a vaccine for RSV.

There are currently two vaccines approved, Abrysvo from Pfizer,and Arexvy from Glaxo Smith Kline’s (GSK). Abrysvo is also approved for women who are 32 to 36 weeks pregnant during September through January (to cover when RSV is typically active). Full disclosure – I was a primary research investigator for one of the Pfizer’s studies, but I make no money from sales of the product.

In one study with Arexvy and influenza vaccines there were two cases of acute disseminated encephalomyelitis (ADEM), and one case of Guillain-Barré syndrome, serious neurologic side effect seen with some other vaccines, and sometimes for no apparent reason. It’s not clear if it was due to the RSV vaccine component, the influenza component, the combination, or unrelated. There were 3 reported cases of Guillain-Barré in the Abrysvo studies.

Although there were few reported cases of Guillain-Barré in the RSV studies, given the severity of the side effect one needs to consider risk versus benefit. For those at high risk, I think the benefit outweighs the risk. It’s harder to know what to do for those who are approved to get the vaccine, but are otherwise at low risk, such as those in their 60’s who are generally healthy. Currently for those patients I’m not encouraging them to get vaccinated, and if they ask, I say they may want to consider skipping it this season. By next season we should have a much better idea of the true risk. If you’re 60-years-old or older, you should discuss with your physician/provider.

It’s not yet known how long the vaccine provides adequate protection, but probably for 2 years or longer. In fact when the companies realized the vaccines would last more than one year, they raised their prices as their original profit calculations assumed people would need yearly vaccinations.

A is for Aspirin

You probably recently read in the news something about aspirin recently, and maybe you’re wondering if you should stop taking it, or you went ahead and already did. I know lots of my patients have been asking me.

The article by the U.S. Preventive Services Task Force talks about the use of aspirin to prevent heart attacks and strokes. They said for primary prevention (meaning to prevent a first heart attack) they recommended shared (between patient and their doctor/provider) decision making for starting aspirin in 40 to 59-years-olds with a 10% or greater risk of having a major heart event (such as a heart attack) in the next 10 years who do not have increased bleeding risk. They recommended not starting aspirin in those 60 and older who have less than a 20% risk.

There are a number of key points.

  • This is a draft recommendation. There is a public comment period and changes will be made before it’s finally published, probably in 6 or more months.
  • The recommendations only apply to starting aspirin.
  • The recommendations do not apply to people who have previously had a heart attack or stroke.
  • They make no recommendations about stopping aspirin other than considering stopping at 75 years old for primary prevention.

For patients who have had a heart attack, stroke, or peripheral artery disease (blocked artery to one’s arms or legs), the benefits of aspirin generally outweigh the risk of bleeding.

The decision to use any medication is always a balance of the benefits versus the risks (and sometimes the cost). Why the change in recommendations? Well in part we generally get progressively better as we accumulate more scientific information. But probably in this case it’s more due to treatment changes. When the original recommendations came out to use aspirin for primary prevention we did not have very good treatment for the conditions that cause heart disease, particularly cholesterol. With improved treatment, there is less incremental benefit from aspirin, yet the bleeding risk remains. That may shift who we should treat.

For now, I’m not recommending any changes before the final recommendations come out. Aspirin was first recommended for primary prevention over a century ago! If taking aspirin was that risky we’d have known there was a problem long ago. I don’t think there is any reason to make any rushed decisions unless someone is having a problem with aspirin.

So you if you are already on aspirin and doing fine on it, and your next appointment to see your doctor will be within 9 months or so, I suggest considering not even asking your doctor until your next appointment. That gives time for the final report to be published, and time for your doctor to consider the information. That’s better than making a decision based on a headline.

As If I Have Nothing Better To Do

Ask most primary care physicians and they will probably tell you they waste a lot of time getting medications approved for their patients. I just dealt with this for one of my patients. He had been on it for four years, but they wanted some information from me. It seems they didn’t trust my judgement and wanted recent lab work to confirm he wasn’t taking too much, even though I had him on the lowest dose. The patient has insurance with Regence, and OptumRx manages the prescription benefit.

I called OptumRx and they first asked if I was a member or calling from a provider’s office. Well if they had separate numbers for each they wouldn’t have to waste time asking that question. Next they asked for my name and title. Then they asked for my NPI number. Once I gave it to them they looked up my name, so they could have skipped the question of my name and merely confirmed it after they had obtained it from the NPI number. Actually they should have already had my NPI number as it was attached to the prescription, that they paid for, and I’m sure is in their records already as they get that information when physicians apply to see (and bill) their patients.

Next they asked for the patient’s member ID number. I told them I didn’t have it, but I did have the reference number they gave when they asked for me to call. I was told they couldn’t use that information, so they asked for the patient’s name and date of birth. I gave it but the person couldn’t find the patient in their system. So she then asked for that reference number. After a while she said that patient wasn’t in the group she managed and she would have to pass me on to someone else.

The next person again asked some identifying information then wanted to know a test result the patient had, as well as the normal range for that test. I gave the three numbers and she said they would be in contact. Less than 30 minutes later it was approved, but that whole call took 9 minutes! That’s an incredible waste of my time just to give 3 numbers. They could have just asked my nurse to give the lab results to them over the phone or fax it to them and not have wasted my time at all. Besides the time I spent, there was also the time spent by a couple of staff members to get the message to me, and the subsequent fax confirming that it had been approved. We deal with lots of these things every day. If physicians were their paying customers, they’d be out of business with service like that.

Let’s be Clear on ClariSpray

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Bayer, the maker of Claritin, has a new product, ClariSpray. This is a good product, but with a confusing name. It has nothing to do with Claritin, other than they are both used for allergies (allergic rhinitis).

It’s actually fluticasone nasal spray, the same ingredient as Flonase, a prescription product, but now available over-the-counter.

Their website does takes pains to explain this, but there are some things things they don’t mention. They don’t say how it compares with Flonase or Nasacort. Although there are slight differences, and some people may prefer one over the other, they are basically similar, and just a matter of personal preference. Bayer’s website also doesn’t tell you that you shouldn’t take ClariSpray if you are taking Flonase or Nasocort, or one of the other nasal steroid sprays only available by prescription.

Gluteus Maximus

I ordered atorvastatin (generic Lipitor) for one of my patients with high cholesterol and Medicare Part D coverage. It was denied. We then appealed it (prior authorization). A fax from Maximus Federal Services said their decision was, “UNFAVORABLE.” They said the patient had not tried and failed one of the preferred generic statins (lovastatin or simvastatin). They did note that we could appeal to an Administrative Law Judge.

In fact the person had tried simvastatin, which I had noted on the prior authorization. However the cost savings is minor. According to Goodrx, a 90 day supply of atorvastatin is as low as $19.25 around where I work.  For the equivalent dose of simvastatin it’s $10.06.

Yes, it’s almost half the price, but it’s still a pretty small amount, especially in my patient who had already had a heart attack, and the difference will only get smaller as Lipitor has not been generic for all that long. Contrast that with the staff time wasted dealing with this on both ends. Dealing with this is a pain in the Gluteus Maximus!

How to Get Rich – A Guide for Pharmaceutical Companies

The Changling Ming Dynasty Tomb of the Yongle Emperor
The Changling Ming Dynasty Tomb of the Yongle Emperor – copyright 2012 Daniel Ginsberg Photography

Thanks to Congress, Medicare is not allowed to negotiate for the cost of medications. The bill was shepherded through by congressman Tauzin, the chairman of the House Energy and Commerce Committee that regulates the industry, who subsequently stepped down then took a job as the President and CEO of the Pharmaceutical Research and Manufacturers of America. This is a lobbyist group for pharmaceutical companies.

Here’s a suggestion to pharmaceutical companies; the next time you come out with a new first in class medication, for which there are no other medications that can be substituted, price it at 10 billion dollars a month. After the first prescription gets filled, it may move Congress to act, but by then you will be set and it won’t matter if you don’t sell another pill.

Medication Small Print

WhenSolu-Medrol_crop I give a cortisone injection, I have to document it in our electronic medical records. I’ve always included the dose, how administered (intramuscular), and the lot number. This week my company added the requirement that we include the NDC number, as insurance companies wanted the information.

It’s just one more administrative requirement, but what really makes it bad is trying to read the number off the bottle. As you can see from the photo, the font is very small! I suggested the policy was age discrimination, but that didn’t get far.

Aspirin – Coated or Naked – Does it Matter?

Aspirin is often used to prevent heart attacks and strokes. Patients usually take an 81 mg (baby aspirin) or 325 mg (regular strength) pill. It also comes in plain, enteric coated, or buffered. Enteric coated aspirin is often recommended to decrease the risk of ulcers, the idea being that it doesn’t dissolve until it gets past the stomach, though there is limited evidence that it really makes a difference.

Another concern over the past decade is that some patients may be resistant to aspirin, and perhaps needed to be on more expensive medications, such as Plavix (clopidogrel), which recently went generic, though is still pricier than aspirin.

Now a new study from the University of Pennsylvania, published in the magazine Circulation, questioned the idea of aspirin resistance, and said that some patients who did not respond to the coated aspirin did respond to plain aspirin. But that does not mean you should conclude that taking coated aspirin may put you at increased risk for a heart attack.

This study looked at 400 health volunteers and gave them a single 325 mg dose of aspirin, either plain or coated, and measured the chemical cyclooxygenase-1 to see if it worked. If they appeared “resistant” then they gave one week each of coated 81 mg aspirin and clopidogrel. Although 49% of the volunteers did not respond to the single aspirin, they all responded to the daily dosing.

So the bottom line is if you take a coated aspirin every day, you probably don’t need to be concerned about it not working. If you don’t regularly take aspirin, but experience chest pain, after you call 911, take a plain aspirin, and preferably chew it to speed absorption. If you only have coated aspirin, it should work just as well if you chew it. Coated aspirin, made by Bayer and other manufacturers, are a little more expensive than plain aspirin, but are still fairly inexpensive.

Over-the-Counter Confusion

Over-the-(sushi)-counterThe FDA allows some medications to be sold over-the-counter (OTC), generally after patent expiration. Pharmaceutical companies need to prove they are safe to be taken that way. But as more medications become available, the opportunities for confusion increase. I’ve had patients confuse Zantac and Zyrtec. The first is for acid reflux and the second is for allergies. Even if drugs have similar names, a pharmacist usually catches the difference due to the dose written on the prescription. For example, Zantac comes in 75 mg, 150 mg and 300 mg, but Zyrtec is 10 mg. The typical lay person doesn’t know what dosages medications are supposed to be. They just (hopefully) know how many pills to take. So if they don’t read the label, they may take the wrong medication due to getting the names confused.

Anti-inflammatory pain medications are particularly a problem. There are OTC versions (Advil, Motrin, Aleve, etc.) and prescription dose strength versions of those, as well others that do not have a generic version. This class of medications is called non-steroid anti-inflammatory drugs (NSAIDS), and usually people should not take more than one at a time. But not uncommonly I see patients take a prescription one plus an OTC one, not realizing they are similar medications. By doing this you get very little additional benefit, but more risk of side effects.

If you use OTC products, be careful to read the labels carefully. If you are taking prescription medications for the same purpose, or you have any of the conditions they warn you about on the label, check with your physician first.