Monday, September 26, 2016

Alternatives to Mylan Pharmaceutical's Effective but Completely Unaffordable Epi-Pen (R)

How can the price of the life-saving EpiPen have gone up from $100 to $600? 'Cuz it's not illegal.

Mylan Pharmaceuticals bought the license for the EpiPen in 2007, and has increased the cost steadily by 600% over the past nine years.  Most patients and doctors have heard of the EpiPen, and a lot of money has been spent on "branding" it, too.

The problem is that other automatic injectors for severe allergic reactions are not perfectly identical to the EpiPen.  This makes sense, since to make one that is truly identical would constitute patent infringement.  The problem is that in most states, pharmacists can't just automatically substitute a more affordable injector for an EpiPen prescription because the alternatives are not truly identical.  In California, pharmacists can make such a substitution, though in my experience they often don't.

Long story short, the Adrenaclick epinephrine injector is an EpiPen-like device that has been around long enough to also be available generically.

Using my handy GoodRx iPhone app (you can also use the app for Android phones, or the website and a printer), I see that the best price locally is at WalMart with a discount for $144.62 for a pair of generic Adrenaclick auto-injectors.

So, if you have severe allergic reactions to things like bee stings, shellfish or peanuts, there is a generic alternative to the EpiPen that can be had for 2007 prices.  Read the instructions carefully, as it is similar, but not identical, to the EpiPen.

Thursday, August 18, 2016

The California End of Life Option Act

The California End of Life Option Act was signed into law in October of last year, and became effective on the 9th of June.  This law is designed to provide a way for patients who are dying of a terminal illness to ask their doctors for medication that they could take if and when they wished to die quickly and peacefully at a time and setting of their own choice.  The law certainly includes many safeguards to prevent patients from being pressured or coerced into asking for or receiving such medications.  Also, it is a potentially time-consuming process and could take up to 2-3 months.

Physicians are not required to participate, so if this is important you need to ask your doctors whether they are willing to participate with you.  If they are not, they are required to be able to refer you to physicians who can serve you in this capacity.

For the record, I am willing to see patients requesting medication, assist with paperwork, and write prescriptions for the medication.

What follows is a hand-out I prepared as a Frequently Asked Question (FAQS) list with links to information and documents.

California End of Life Option Act

Signed into law by Governor Brown: 10/05/15 as AB-15

In effect: 06/09/16

Date of repeal by its own terms: 01/01/26, unless extended by the Legislature

It is now legal for dying patients to request a prescription for medication that would allow them the option to die peacefully at their own choosing if they wish, and it is now legal for doctors to prescribe such medication and for pharmacies to dispense it. 

Who is eligible for medical aid in dying?
·         Adults
·         Terminally ill
·         Prognosis of six months or less to live
·         Mentally capable of making own decision (Note this excludes patients with Alzheimer’s or other dementias, or patients with developmental delays.)
·         California resident
·         Acting voluntarily (without duress, fraud or undue influence)
·         Able to take and swallow the medication
·         Patients informed of all options (such as stopping life-prolonging treatment, palliative sedation, voluntarily ceasing to eat or drink, hospice care)
·         Patients informed that they may obtain, but not take the medication

Do people support this?
·         Yes. 68-74% of people in Gallup and Harris polls support medical aid in dying.

Do medical professionals support this?
·         Yes. 54% of doctors support this in a Medscape poll.
·         This Act is endorsed by the American Nurses Association/California, the California Psychological Association and the California Primary Care Association.

Do doctors have to participate?
·         No, but they have to provide information about medical aid in dying, and refer patients to supportive medical providers.

What cause of death will be on the Death Certificate?
·         Cause of Death will be the underlying terminal illness.
·         The law specifies that death from self-administering aid-in-dying medications is not suicide.

Does this affect a will or insurance?
·         No. Accessing medical aid in dying does not adversely affect a person’s will or insurance.
·         The law specifically mandates that wills, insurance, contracts and annuities are not affected if a qualified individual shortens their dying process by ingesting aid-in-dying medication.

How does this apply to disabled or older people?
·         The law specifically states that no one can qualify for aid-in-dying medication based solely on their disability or age.

How does this affect guardians or conservators?
·         Guardians and conservators may not be appointed solely because a person makes a request for aid-in-dying medication.

How long can such a request take?
·         At least 15 days, perhaps up to 3 months

How much does this cost?
·         There are at least 3 doctor visits, dedicated solely to aid in dying issues
·         The pharmaceutical company that makes the necessary medication increased the cost a few months ago to almost $3,000; at least for the easiest to use one that comes in easily opened capsules.
·         One that comes in tablets that would have to be crushed costs about $16.

Where can I find the necessary paperwork?
·         The California Department of Public Health allows you to download the necessary forms.

·         Compassion & Choices is a great resource for information.

What are the steps involved in requesting aid-in-dying medication?

Please note you must have the physical and mental ability to self-administer and ingest the medication, and you must be able to prove California residency- details to follow. Also, you yourself must make the request.  The request cannot be made on your behalf by any other person, regardless of their relationship to you. 

1.      Make a total of three voluntary requests; two oral requests 15 days apart, plus one written request using the Patient’s Request for Aid-in-Dying Drug form signed by two witnesses, directly to your doctor.
a.       No specific order is needed.
b.      The witnesses attest that you:
                                                              i.      Are known to them or have provided proof of identity (driver license, proof of voter registration in California, proof of owning or leasing property in California, or proof of filing a California tax return for the most recent tax year), and
                                                            ii.      Voluntarily signed the request in their presence, and
                                                          iii.      Appear to be of sound mind, and not under duress, fraud or undue influence.
c.       Only one witness may be related by blood, marriage or adoption, or be a person entitled to a portion of your estate upon your death
d.      Only one witness may own, operate or be employed at a healthcare facility where you receive medical care or reside
e.       Your regular doctor, consulting doctor or mental health specialist cannot be one of the witnesses.
2.      Give fully informed consent.
3.      A consulting doctor must complete the Consulting Physician Compliance Form, basically stating agreement with your Attending or regular physician.  Your regular or attending doctor must refer you to a consulting specialist for this purpose under this law. (Health and Safety code, Section 443.5 (a)(3))
4.      Complete the Final Attestation for Aid-in-Dying Drug form within 48 hours prior to ingesting the aid-in-dying medication.  This re-states your intent to take the medication, and your awareness of the consequences.
a.       After your death, this completed form must be delivered to your regular doctor so it can be included in your medical record.

You can use an interpreter, but your interpreter must sign the Interpreter Declaration Form which shows that you understand the needed forms as listed above when read to you by an interpreter.


Compassion & Choices materials 02/17/16

CMA On-Call Document #3459, 01/2016

Orentlicher, D. et al. (2015). Clinical Criteria for Physician Aid in Dying, J.Palliative Medicine, vol. 18, No. X.

Feel free to share this website with others, but please ask me before copying or distributing this posting.

Please feel free to see me if you have any questions about the End of Life Option Act.

Wednesday, July 20, 2016

Hearing aids for folks who maybe need them but can't afford them

As I've mentioned before, good hearing is not over-rated and bad hearing can be dangerous, socially isolating, and it is strongly linked to Alzheimer's dementia.

On the other hand, insurances generally only cover about $500 of what can be a $4,500 pair of hearing aids.  It's worth the money, but that doesn't help if you don't have that kind of money!  That goes a long way towards explaining why only 20% of people who need hearing aids actually have them.

Happily, there is a lot of interest in effective, more affordable devices.  However, it's definitely a "let the buyer beware" marketplace out there since they are being sold as assistive products and not pure medical devices.  Also, be aware that if you have severe hearing loss (as opposed to mild or moderate) these are not going to help you.

This article provides some information on three different models of Personal Sound Amplification Products (PSAP's) which a group of audiologists (hearing specialists) at Johns Hopkins have tested and found to be recommendable.  They do point out that so far they've only tested them in 29 people, so mileage may vary.

All three of the recommended devices are around $350, and all three are monaural which is to say that they go in one ear.  The Soundhawk and the CS50+ both look a bit like a Bluetooth in-ear headset.  The Bean T-Coil looks more like a small conventional in-ear hearing aid.  I gather that you get used to amplifying sound in one ear quickly enough. 

It certainly seems that these are all effective, comfortable devices that can help you hear better for a much more affordable price!

Monday, June 13, 2016

Proper Sunscreen Use

Julia Belluz does a great job of reviewing some of the frequently asked questions about sunscreens.

Do chemicals in sunscreens hurt me?
  • So far, there is no evidence of organ injuries or cancers being caused by chemicals in sunscreens.  Certainly, there is a known risk of skin damage and skin cancer in not using them.
Do sunscreens cause Vitamin D deficiencies?
  • No.
Do sunscreens expire quickly or get damaged by heat?
  • Consumer Reports found that sunscreens last for years after purchase, but
  • they can be rendered ineffective by being over-heated at the beach or in your car.
 Is higher SPF better?
  • SPF 30-40 is fine.  Many sunscreens overstate SPF, so if you want a general purpose SPF 15, get SPF 30 just to be sure.  On the other hand, there is very minimal additional benefit at SPF 45 or higher.
How much do I need to use?
  • Quite a bit, actually.  It takes about a fluid ounce (1 shot) to cover your whole body, on average.
  • Plus, it needs to be replenished every two hours as the chemicals have absorbed harmful UV radiation.  

The back and forth pendulum swing of narcotic pain-killer use.

The story of Prince being found to have died due to an overdose of fentanyl is reflective of narcotic pain killer use in our country.

I say our country because the U.S. represents less than 5% of the world's population but uses over 95% of its narcotic pain-killers.  I think it's unlikely that we have 95% of the world's physical pain.

Not long ago, pain-killers such as morphine, Demerol, Dilaudid, Percocet or Vicodin were pretty much only used right after a surgery or in people dying of cancer.  Prescribing these medications for long periods of time was very much frowned upon and could result in doctors coming under investigation or prosecution for over-prescribing them if complaints arose from families, pharmacies or other doctors.

Some time in the late 1990's, the pendulum swung fully in the opposite direction.  The above link does a pretty decent job of describing it.  In California, doctors were required to take a course covering this change: pain was "the fifth vital sign", pain-killer addiction was rare, tolerance to them uncommon, and patients reporting more pain were to be assumed to be suffering a worsening in their condition (as opposed to narcotic pain-killer tolerance or addiction).  Along with this, there were a number of laws, regulations or legal precedents requiring doctors to prescribe the perfectly right amount of narcotics or risk sanctions and lawsuits.  Doctors got found against for over-use and also for under-use, or for not referring patients to doctors who would prescribe pain-killers.  A surgeon on a widely read medical website shares his recollections of these times, too.

At this point, it is fair to say that this didn't work out as intended.  And mind you, intentions were good.  Chronic pain not related to cancer exists, and no one liked to see people suffering with it.

It was certainly a tipping point when Purdue Pharma developed and heavily marketed OxyContin.  I remember  a pharmacist from a big hospital center in Seattle giving a presentation on it to doctors at Marshall right after the FDA approved it.  It was touted as being a slowly released, long acting, abuse-proof non-addictive 12-hour narcotic pain killer.  It was sold as being insoluble with water so could not be injected, and providing good pain relief with only two doses a day.  Turns out, none of these statements are true.  It didn't take long for people to realize that injecting it for a fast high was impossible, but smashing it and snorting it worked just fine.  Worse yet, the pills in no way lasted 12 hours; more like 8 hours.  Worst of all, Purdue Pharma knew this, but lied.  They knew that doctors would be a lot less likely to prescribe a medication that had to be taken every 8 hours to work.  Only now are they admitting to this fraud.

Certainly, narcotic pain medications have a role in the treatment of acute and chronic pain.  It is simply time for the pendulum to swing back to a reasonable point somewhere in the middle.

Monday, June 6, 2016

Do acid reducing medicines cause dementia?

Recent press coverage suggested that proton-pump inhibitors can cause dementia.  Unfortunately, press coverage seems to have overstated this a bit.

Proton-pump inhibitors (PPI's) are a specific type of acid reducing medication used to treat a variety of conditions such as acid reflux, esophagitis and ulcers.  They include a number of prescription and over-the-counter medications such as Prilosec, Prevacid, Protonix, Nexium and Dexilant.

Basically, an article printed in April in the Journal of the Amercan Medical Association (JAMA) described a German study showing a correlation between PPI use and dementia.

Thing is, correlation is not causation.  This study did not define particular types of dementia, such as Alzheimer's, Parkinson's, Lewy body, vascular or senile dementias.  Also, it did not take into account risks such smoking or drinking.  Both of these would cause stomach problems and are common causes of being on PPI's, and both are by themselves associated with Alzheimer's disease risk.

In other words, a limited study with a number of significant weaknesses reports that many patients with various forms of dementia have taken PPI's.  It in no way establishes that PPI use causes dementia. 

Other acid reducers, called the H2 blockers include Tagamet, Zantac and Pepcid.  These, so far, have not had any  harm from long-term use associated with them.

Generally, it makes sense to use PPI's for very specific conditions such as treatment of Barrett's esophagitis or ulcer prevention with anti-inflammatory pain (NSAID) medication use and to otherwise use H2 blockers or non-medication related supportive care (such as not smoking, and modest alcohol consumption).

Wednesday, June 1, 2016

Staring at screens all days can hurt your eyes; cell phone use still not linked to brain cancer. Just saying.

The recent media coverage suggesting a link between cell phone use and brain cancer is so far a bit histrionic and less than nuanced.

So far, numerous studies have (happily) failed to demonstrate a link between cell phone use and brain cancer.  The recent media coverage involves an unpublished interval report on a long and unfinished study on such risk. 

Long story short, to suggest that this report proves that cell phone use can cause people to get brain cancer would assume:

  • risk of brain cancer due to cell phone exposure in rats equates to risk in humans (the study is using mice as test animals)
  • female brains are protected from cell phone exposure (no cancers occurred in the female rats)
  • controls are cured of cancer (the control population had lower rates of cancer than the experimentals)
This does not invalidate this ongoing study; it simply points out that the study is unfinished, the interim report unpublished and it contains a number of findings raising reasonable concerns of its scientific validity to date.  Vox and NYT did a good job of critiquing this study and its media coverage.

On the other hand, it does seem likely that staring at screens all day can make your eyes feel itchy, dry and uncomfortable. (Which makes it harder to read the screen...)  Jane Brody covers some studies on this well, and also offers some useful solutions.

Monday, May 16, 2016

Can you have too many tests?

(Hint: Yes.)

Screening and diagnostic tests are valuable tools in helping doctors to prevent illnesses, find medical conditions at early treatable stages, and identify or exclude medical conditions as causes of patient symptoms.  By definition, screening tests (such as annual cholesterol testing: can we keep you from having a heart attack) are done to prevent problems or to identify them before they have actually started to cause problems.  Diagnostic tests (such as heart muscle enzyme tests: are you having a heart attack) are done due to symptoms or other problems.

Doctors learn as early as medical school that just the right amount of testing is the best.  Too little can lead to delays in diagnosis and treatment, too many can confuse the matter by raising "red herrings".

Theranos is one of the most heavily financed start-ups in history.  The company proposes break-through technology which would allow most blood tests to be performed on no more blood than a relatively painless prick of the finger (rather similar to what diabetics do to check their blood sugar).  Their eventual goal seems to be to set up free-standing labs in retail locations such as Walgreen's that would allow people to pay for any lab test as often as they want without requiring a doctor's order.  Presently, the company is beset by serious questions regarding data they seem to have generated using standard lab testing equipment and a number of other major issues. (The Wall Street Journal has quite a bit of coverage on this, but it is pay-walled.)

I don't have any financial stake in any labs or X-Ray facilities and am generally in favor of transparency and the exercise of free will.  Frankly, I imagine I would be seeing patients who are concerned about abnormal tests as often as I already see patients for abnormal symptoms if Theranos were already up and running.  In other words, I would not find their existence threatening.

My issue with Theranos' proposal is that selecting and interpreting tests is complex.  (As in if it wasn't so complex, pathology wouldn't me a medical specialty and medicine wouldn't be a profession.) 

  • If you are concerned about a specific condition, you have to know what tests will help to identify and/or exclude it.
  • You have to know when a test result that is outside the reference range is significant and when it is benign.
  • You have to know when results that are technically within the reference range are significant.
  • You have to be prepared to act on expected and on unexpected results.
Katherine Hobson at FiveThirtyEight does a great job at addressing the greater concern; we don't necessarily need more tests.

Friday, May 13, 2016

Side windows let more UV in than we thought

We have known for some time now that Americans get more skin cancers on the left side of sun-exposed areas like the forearm, face and neck since we drive on the side of the car (and we do drive a lot).

More recently, it seems that the amount of ultraviolet (UV) sunlight that can get through the closed side window of cars can be quite high. 

The windshield typically blocks 96% of UV.  This is due to its 2-layer construction that makes it hard to shatter in a crash.  On the other hand, side windows are not required to be so crash-safe.  Some models (such as Lexus) block as much as the windshield.  Others only block about 70%.

Until side windows catch up, the best way to prevent skin cancers due to this exposure is to apply some sunscreen before you drive.

It's also worth remembering that applying some SPF 30 every day (even if you are not going out) prevents skin cancer, both prevents and reduces freckling and moles, and also prevents sun-related wrinkling and aging of the skin!

Tuesday, May 3, 2016

Medical Errors

A recent article in British Medical Journal looked at the occurrence of fatal medical errors in a group of US hospitals and found that if the error rates found in this group of North Carolina hospitals applied nationwide, it would make fatal medical errors the third most common cause of death in the US (falling between cancer and COPD).

On the one hand, this article did not break down the findings as to what causes of medical errors were found.  It also assumes that the errors found in this group of hospitals does apply to all hospitals in the US.

On the other hand, if it even comes close to being an accurate projection that ain't good! 

The possible causes of fatal medical errors are numerous.  The potential for communication errors is high, given the number or parties and third parties involved: patient, doctor, family, office staff, pharmacy, insurance company, "mail-order pharmacy", etc., etc.

The introduction and requirement for electronic medical/health records (EMR/EHR) is probably not helping.  Doctors, nurses and pharmacists all have different parts of it and they sometimes don't overlap.  Remember the first US Ebola patient who showed up in an ER in Texas?  The patient was asked about recent foreign travel, he truthfully answered yes, the nurse responsibly checked the box "Yes" on the question of recent foreign travel but it did not appear in the doctor's information at all.  This break up of information flow is intended to keep people with different tasks from being overwhelmed with information not directly relevant to their tasks and is a common feature of most EHR's.

The design of EHR is quite poor.  Some studies show doctors spending 44% of their time on data entry and 28% of their time on actually care of the patients.  Frankly, it makes me glad I never fully bought into EHR!

I hope this article prompts us all to take a real hard look at our present methods or error reduction and find ways to quickly and effectively improve on them.

Saturday, March 26, 2016

Zika Virus: how long should we wait to try to get pregnant?

Our understanding of Zika virus is developing daily.  As many are aware, the link between Zika virus exposure or infection and birth defects (microcephaly) is becoming stronger.

The Centers for Disease Control (CDC) has just issued recommendations on family planning and Zika.

Long story short;
  1. If you are a woman who traveled to a Zika endemic area and developed symptoms, wait at least 2 months before trying to get pregnant.
  2. If you are a man who traveled to a Zika endemic area and developed symptoms, wait at least 6 months before having unprotected sex.
  3. If you are a man or woman who traveled to a Zika endemic area and did not develop symptoms, wait at least 2 months before trying to get pregnant.
  4. If you are a man who traveled to a Zika endemic area with a pregnant partner, use condoms for any form of intercourse for the duration of the pregnancy.
  5. To prevent the spread of Zika through sexual intercourse, men who have traveled to Zika endemic areas should use condoms for any form of intercourse for 2 months if they did not develop symptoms, and for 6 months if they did develop symptoms.
  6. If you are a man or woman living in  a Zika endemic area, then it gets really tricky:
    1. The CDC did not recommend that women delay pregnancy.
    2. El Salvador has recommended that women wait until 2018 to get pregnant.
    3. Brazil, Ecuador, Columbia and Jamaica have recommended that women delay pregnancy indefinitely for the time being.
Please read the link for more detail, and also my previous post on Zika for further information including a description of symptoms of Zika infection.

Saturday, March 19, 2016

Zika Virus

I think we're only going to be hearing and reading more about Zika in the very near future. Spring is here, more people will be traveling on vacations, and the possibility of Zika outbreaks in the lower 48 will increase (the range of the carrier mosquitoes includes the Southeast US). This could raise issues of governmental regulation, access to abortion, climate change and immigration during a presidential election year.  I hope that any such discussions will be in the interests of the public health, and will shed more light than heat.

Zika has actually been identified in the 1950's in West Africa, then in the late 1960's in the South Pacific.  Since then, it has emerged elsewhere and most recently in South America and now Central America, including Puerto Rico which is a US territory.  It is carried by two species of Aedes mosquitoes whose effective range includes large areas of the Southeast and Atlantic Seaboard.  Aedes was responsible in the 1900's for yellow fever outbreaks in the South and as far north as Boston and New York City.  Aedes can also carry dengue hemorrhagic fever and chikungunya which are being seen in Central America and border states in the US.

At this point, Zika has been linked to a rare birth defect called microcephaly in which a baby is born with an abnormally small head and may develop lifelong developmental delays.  Happily, this appears to affect only 1% of women who were infected with Zika.  On the other hand, Zika infections are acquired through mosquito bites and are in 80% of cases without any symptoms at all.  In the other 20% of cases, the symptoms are quite mild: fever, aches, rash and reddened eyes are the most common.  Those symptoms are of course quite common to any viral illness at all, including common colds and flu.  And on top of this, Zika can be sexually transmitted for an unknown period of time after initial infection.

Due to the recent emergence of Zika in the Americas and the alarming link to microcephaly, Zika raises a lot more questions than answers at this time.  A vaccine is years away, and there are no readily available commercial lab tests for Zika.  Fluid specimens can be tested by a special division of the Centers for Disease Control (CDC) in Atlanta, but we are far from simply taking a lab slip to the lab for testing.

So, what to do at this point?
  • Eliminate standing water near your home including old tires, up-turned buckets and the like.
  • Use DEET-containing mosquito repellent and clothing that covers you.  If you are using it along with sunscreen, apply the sunscreen first and then the repellent.  Do not use combined sunscreen plus repellent products as this can lead to bloodstream absorption of DEET.
  • Get window and door screens.  
  • Use a mosquito net over your bed.
  • Exercise these precautions and pack accordingly in travel to endemic areas, if you cannot avoid travel there in the first place.  (Personally, I would stay away from the Summer Olympics in Brazil.)
  • If you are thinking of getting pregnant, this is a tough choice.  There are no clear choices and the best news is that even in the face of Zika infection, the odds your baby will be normal and healthy are 99% in your favor.
Here are links to some helpful information and resources on Zika Virus: