In 1991 a study came out that showed that the popular drug Inderal, a drug used for blood pressure control, also had an another effect of minimizing performance activity. This drug slows the heart rate and keeps it from elevating as we often see when we are nervous. The study showed that students that took the drug before taking the SAT test had better scores. Golfers on the PGA tour also found that this impacted performance activity as it kept their heart rate down and decreased performance anxiety.
Minoxidil the drug that many of you may know as its trade name Rogaine, was first used in the 1960’s as a treatment for high blood pressure. As they ran the clinical trials for the clinical drug trials they tracked side effects of the medication and they found that many men taking the drug for blood pressure reported that they had hair growth. The company that owned the rights to Minoxidil at the time was Upjohn. Upjohn did not want to get into the “miracle cure for baldness” and did not test it or promote it for that outcome. Once it got on the market as a medication for high blood pressure it did not take long for the secret hair growth portion of the side effects to spread in the media. A letter to the New England Journal of Medicine, discussing the impact on hair growth stopped any chance that Upjohn had in keeping the side effect under wraps. 50 years later it is now a drug that is used for hair restoration and hair growth.
Well those may be interesting and actually may make you laugh or smile a little. The story that broke last week may irritate many of you, anger some of you and disgust others of you. Last week it was shared that a blockbuster drug for arthritis, Enbrel, may actually work to prevent or lower the risk of Alzheimer’s dramatically. The irritation, anger and disgust will come from the fact that they have known this for the past 4 years and have not shared it, have not pursued further investigation and most importantly did not release the findings. Anyone who has lost a loved one to this terrible disease, or has a loved one suffering thru the disease may be angered to not have the opportunity to be part of a trial that may show it stops or slows the progression. Others who are entering the age we see this disease present may be angry if after a full clinical trial it is shown that individual after the age of XX should be taking this drug as a preventative measure to decrease your risk of Alzheimer’s.
Even more disappointing is the fact that they have slowed the opportunity to work on this drug to make it more effective than it already appears to be. The frustration is even higher as we find that this drug does lower the risk by 20%. Or 40% but in a study of thousands it lowered the risk of Alzheimer’s by 64%. Researchers made this finding in 2015 after reviewing the records of hundreds of thousands insurance claims. Pfizer had that data and decided against moving forward to run a clinical trial that may have proven what the insurance claims had shown. The researchers urged for the clinical trial, which would have cost $80 million dollars but the company decided against it.
When hearing this initially many are angry, Pfizer however says that they chose not to follow up as they had proven that Enbrel does not reach the brain, so they felt the clinical trial would not be successful. They felt a review of insurance records may not stand up against the strict scientific standards. Science is why Pfizer chose to not move forward on this finding. Pfizer also doubted the data and that is why they decided to not release the findings.
Many feel this was improper, and if Pfizer decided not to pursue the possibility, at least make the findings available to other researchers. Alzheimer’s is a frustrating illness and even with billions of dollars spent each year on research we still do not have any effective medications for treatment, prevention or to even slow the illness.
Enbrel is a very strong anti-inflammatory medicine used to treat Rheumatoid Arthritis or RA. RA is an disease where the body for some reason attacks the lining of the joints in our body and causes inflammation and pain in the joints, it is a debilitating condition that in many people is controlled with the use of Enbrel. The frustrating thing to some researchers is that inflammation is thought to be one of the triggers for Alzheimer’s and that this data would have been very valuable for them. Now many of you may say that Pfizer is probably looking into this and will come out with a new blockbuster drug after they tweak Enbrel to save and extend the patent ( Enbrel patent is set to expire in 2026), but that is far from the truth as Pfizer has decided to totally get out of the Alzheimer research and shut down that branch of the company on January 2018
The pharmaceutical business is a big business, Enbrel is one of the most popular drugs in use today and it has a high price tag to go along with it. Enbrel was responsible for 2.1 Billion in profits for Pfizer. The cost of Enbrel varies widely based on insurance coverage, co pay, Pfizer assistance and Medicare supplemental insurance to name a few ways to lower the cost. The cost without insurance can be $1,200 for each injection, with the patient often receiving 1 injection a month. The $60,000 a year cost has sent many patients who would benefit greatly from this drug back to less expensive drugs with less than ideal outcomes. Many companies are working on biosimilar drugs to Enbrel to hopefully cash in on this condition. Pfizer actually has another RA drug that has come out recently as they see the horizon for Enbrel to be over as generics will cut deeply into the profits. You have all probably seen commercials for Xeljanz.
Had this story not come out, we may have seen Enbrel go to generic without the information getting out and who knows we may have had another Minoxidil.
1.) Alzheimer’s is the 6th leading cause of death in the US
2.) 5.8 million Americans are currently living with Alzheimer’s, this includes 200,000 with early onset Alzheimer’s
3.) One in three seniors dies with some form of dementia
4.) Every minute someone in the US develops the disease
5.) Cost of Alzheimer’s in 2019 will approach $300 million dollars
We heard last week that baseball great Bill Buckner passed away last week at the age of 69 from Lewy Body dementia, the same terrible illness that took Stan Mikita as well. Lewy body dementia is one of the most common types of progressive dementia in the US. There are close to 1.5 million cases of Lewy body dementia in the US. It typically affects individuals after the age of 50. Survival after the initial diagnosis is about 8 years and the disease progresses with increasing disability.
Lewy Body Dementia diagnosis can be made with a combination of symptoms and a biomarker test.
Dementia is required, which simply means a decline in thinking skills that interferes with everyday life. In early LBD, memory may be relatively normal in comparison to Alzheimer’s disease. Instead, a person with LBD experiences problems with other cognitive skills, which may need a neuropsychologist for assessment:
- Paying attention
- Reasoning and problem-solving, called executive function
- Understanding how objects relate in three-dimensional space, called visuospatial skills.
At least two of the following clinical symptoms are required:
- Delirium-like fluctuating cognition: unpredictable changes in thinking, attention, and alertness
- Repeated visual hallucinations
- REM sleep behavior disorder (which may appear long before the dementia)
- Parkinsonism, specifically slowed movements, tremor when limbs are at rest, and muscle rigidity
LBD also has other symptoms that support a diagnosis but are not so common that they help make the diagnosis. Two new supportive symptoms added to this list are the loss of smell and excessive daytime sleepiness.