Big Pharma, Government and the FDA

Welcome and thank you for reading this week’s blog.

I have made mentioned in the past what appears to be a reluctance by the FDA to recognize the potential benefits of Hemp and Cannabis products and how, by doing so, they are hindering the development of the industry and how without proper regulation have allowed the market to be flooded with inferior products and false statements that only serve to take advantage of the consumer.

Hopefully, the following will better explain my position. Remember, this is merely my personal feelings, supported by some information that I have discovered, and do not convey any opinions other than my own.

On December 30, 2019 Congress passed the Further Consolidated Appropriations Act of 2020 which was later accompanied by the Joint Explanatory Statement directing the FDA to conduct a sample study of the current CBD marketplace to determine to what extent products are mislabeled or adulterated. Shortly thereafter, the FDA submitted its report which unfortunately failed to adequately respond to Congress’ request to solve the rapid flood of mislabeled and unsafe CBD products in the marketplace.

The response goes on to say that though the agency “recognizes the significant public interest in CBD products”, it was concluded that the FDA is not yet able to regulate these products and ensure public safety due to the limited data available for said products.

Ironic isn’t it that the agency responsible for limiting the research is saying that the reason for their inaction is due to the lack of research?  Keep reading and I think I can further clarify this enigma.

To date, the first and only FDA approved prescription cannabidiol drug is Epidyolex which is used to treat seizures associated with Lennox-Gaustault syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients one year of age or older. Beyond that, little has been done “officially” to determine what, if any, effects CBD and hemp products may have on a the various maladies many manufacturers claim it has.

To make matters worse, in November 25^th, 2019 the FDA issued warning letters to 15 companies for selling products containing cannabidiol (CBD) in ways that violated the Federal Food, Drug and Cosmetic Act (FD&C act). In addition, they also published a revised Consumer Update detailing safety concerns about CBD products. In a “nut shell” they were restraining companies from doing business due to the fact that they were not able to meet the requirements that they, the FDA, had failed to establish.

That leads one to question, what is the basic function of the FDA and why are they reluctant to lend credence to holistic remedies that have existed for thousands of years? Keep following along while we further examine both of these questions.

The FDA is an agency within the U.S. Department of Health and Human Services which, based on their charter, promotes and protects the public health, among other things, by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The “agency” is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic regulation and for regulating tobacco products.  

While this may sound quite benevolent, keep in mind, this is also the “agency” assigned the task of regulating the pharmaceutical companies responsible for producing the ever growing supply of opioids that are becoming increasingly abundant in today’s world and were (allegedly) responsible for over 70,000 drug related deaths in the U.S. in 2017.

On July 6^th, 2018 BioSpace.com posted an article stating “has the Food and Drug Administration failed to do its due diligence in finding and reporting financial conflicts of interest between members of its scientific advisory committees and pharmaceutical companies?

According to Science, the publication poured over payments made to advisers during the years 2013 to 2016. The investigators looked for evidence of payments to advisers that had a product before the committee as well as payments from rival companies due to the potential impact of the committee analysis and ruling. Science additionally noted that its researchers examined research funding made from a company to a research institution associated with an adviser. Such donations, which typically support principal investigators, can have an enormous impact on a “scientist’s career advancement, compensation or professional influence.

Over the course of their investigation Science discovered:

·         Forty of 107 physician advisers, on the committees, “received more than $10,000 in post hoc earnings or research support from the makers of drugs the panel voted to approve, or from competing firms,” the publication said. Of those 26 received more than $100,000 with seven of those gaining $1,000,000 or more.

·         Science went on to note that 17 top-earning “advisers” benefitted from more than $26 million in research assistance or personal payments from industry companies. Of those payments, 94 percent “came from the makers of drugs those advisers previously reviewed or from competitors. Many of the advisers received funds from those companies that were reviewed concurrent with or in the year before their advisory service.  According to Science, the payments were disclosed in scholarly reports but, not by the FDA.  

This is just a small excerpt from the article. I urge you to look it up for additional information. It does bring up the question of how does this agency and these advisers accomplish this? Well the answer unfortunately is the lack of proper oversight of Big Pharma by our government and the FDA.

OpenSecrets.com, a website operated by the nonpartisan Center for Responsive Politics, tracks money in U.S. politics. They ranked the top 20 members of the house and senate that have received the most campaign contributions from the pharmaceutical and health products industry during the 2017-2018 election cycle.

The website defines the industry as including not only drug manufacturers but also dealers of medical products and nutritional and dietary supplements.

The results are posted below and while we are not judging the individuals listed nor implying there was any nefarious activity, we are questioning whether the influence of big pharma may be a contributing factor in regards to the FDA’s treatment of cannabidiol and hemp products?

 

Party Split:	Dems: Repubs: Others:  $14,952,644  $14,310,571  $60,929
All Candidates:	$29,324,144
Incumbents Only:	$24,227,051

 

House	# of Members	Average Contribution	Total Contributions
Democrats	193	$36,428	$7,030,755
Republicans	223	$45,248	$10,090,431
Independents	0	$0	$0
TOTAL	416	$41,157	$17,121,186
The US House of Representatives has 435 members and 5 non-voting delegates. Totals may exceed 440 due to mid-term replacements.

 

Senate	# of Members	Average Contribution	Total Contributions
Democrats	48	$91,290	$4,381,948
Republicans	48	$55,479	$2,663,008
Independents	2	$22,704	$45,409
TOTAL	98	$72,351	$7,090,365
The US Senate has 100 members. Totals may exceed 100 due to mid-term replacements.

 

 

 

Top 20 Members

Candidate	Amount
Casey, Bob (D-PA)	$540,192
Walden, Greg (R-OR)	$458,700
McCarthy, Kevin (R-CA)	$397,150
Heitkamp, Heidi (D-ND)	$355,575
Paulsen, Erik (R-MN)	$336,550
Brady, Kevin (R-TX)	$311,800
Neal, Richard E (D-MA)	$281,250
Donnelly, Joe (D-IN)	$272,082
Tester, Jon (D-MT)	$257,480
Roskam, Peter (R-IL)	$252,553
Heller, Dean (R-NV)	$249,417
Pallone, Frank Jr (D-NJ)	$247,700
Walters, Mimi (R-CA)	$247,425
McCaskill, Claire (D-MO)	$246,823
O'Rourke, Beto (D-TX)	$240,714
Blackburn, Marsha (R-TN)	$233,996
Hatch, Orrin G (R-UT)	$233,589
Barrasso, John A (R-WY)	$229,900
Guthrie, Brett (R-KY)	$228,950
Peters, Scott (D-CA)	$225,431

 

 

Recognize any of the names? I am sure you do but, that only furthers the question of how does this affect me? For the most part, it has little affect unless you have lost a loved one due to a drug overdose that could possibly been averted had there been an alternative compound to reduce their suffering.

Also, for those that have various health issues and have had little to no luck seeking relief using non-prescription medications or supplements, there may still be an avenue for you as well.

The real issue is, we may very well never know as long as the “agency” continues to drag its heals while continuing to fill its coffers with monies supplied by those that have the most to gain by not finding a suitable replacement for the drugs that are currently available.

Don’t just take my word for it. If this issue is of interest to you please, take the time to educate yourself further and contact your representatives in congress and implore them to move on this topic.

Until then, thanks for reading and good health to you all...CBD Doc.