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Cannabis, Kratom and the Drug Approval Process

 8 min read / 

The United States is all over the place about drugs and drug prices. Americans think they pay too much for drugs compared to Europe.

They do pay more, arguably because in Europe governments set, or at least negotiate, the prices. In the US, the government doesn’t have that power. For one thing, because it doesn’t have universal healthcare, there is no single negotiating body. Each healthcare insurance provider must negotiate with pharmaceutical companies individually.

Instead, the US contemplates purchasing drugs from nations with lower prices and bemoaning the “fact” that they subsidize the drug development costs for the rest of the world.

Why the US Can’t Lower Drug Prices

Since his campaign in 2016, President Donald Trump has pledged to bring down the across-the-board high costs of pharmaceutical, which are at least 50% higher than in Europe. Then he appointed a former Big Pharma CEO Alex Azar as Secretary of Health and Human Services. Azar acknowledged that no pharmaceutical company has ever lowered the price of a drug.

Trump also campaigned on allowing Medicare (the federal health insurance programme for people who are 65 or older, certain younger people with disabilities, and people with ESRD or end-stage renal disease) to negotiate with pharmaceutical companies for lower prices. By the time he took office, however, he had embraced his political party’s free-market economic principles that require each healthcare provider to negotiate on its own behalf with each pharmaceutical company.

(He also promised to increase access to drug rehab and the anti-overdose drug naloxone, but there’s been little movement in that direction. Maybe he wants private healthcare — Blue Cross Blue Shield or Aetna drug rehab — to handle it without government help or direction.)

Drug Approval Process

The US also complains that the drug approval process takes too long, longer than in Europe. Other analyses find that though US “regulatory reviews” take longer than in the European Union, the time from application to availability is roughly the same or shorter, in the US.

President Trump has made arguably conflicting noises about “experimental” drugs, those that have not received US Food and Drug Administration approval. Trump says he approves their use for people with terminal illnesses. If lack of FDA approval makes a drug experimental, then there are other drugs that are widely believed to have health benefits he could allow.

Cannabis

Cannabis is the best-known of these drugs. It is used for the treatment of chronic pain, post-traumatic stress disorder and opioid addiction recovery, based on largely anecdotal evidence. At the very least, it is less toxic than the prescription opioids and heroin that are driving the opioid epidemic. Cannabis, or marijuana, is less addictive (perhaps not at all physically addictive), and no one has ever had a fatal overdose from cannabis use. More than half the states (and population) have approved medical marijuana use, and Trump campaigned on letting the states decide.

Since the election, however, Trump has appointed anti-marijuana warrior Jeff Sessions as his Attorney General. Sessions has said good people don’t smoke marijuana and wants to enforce federal marijuana prohibition despite the will of the states and the people. Even if you want to study marijuana, you need approval from three US government agencies first: the FDA, the National Institute on Drug Abuse (NIDA) and the Drug Enforcement Agency (DEA). The only approved source of marijuana for study is a NIDA-controlled farm at the University of Mississippi.

Kratom

Marijuana isn’t the only promising drug that the FDA opposes. Kratom, a heretofore largely unregulated drug, has come under greater scrutiny recently because of health and addiction concerns.

Kratom isn’t technically considered a drug; it’s sold as a herbal supplement. Like cannabis, many users believe it can be used for chronic pain, opioid cessation, and other uses. It’s even available in vending machines. It is not legal throughout the US, however.

The FDA doesn’t approve and has recently come out with a report that says kratom is an opioid (perhaps true, but this seems to be an attempt to tar it with the same brush as heroin and fentanyl) and responsible for dozens of deaths. A closer examination of the claims found that most (if not all) involved the use of other drugs simultaneously with kratom. One death was actually due to a gunshot wound to the chest, though kratom was found in the system.

Kratom’s legal status varies throughout Europe. The EU equivalent of the FDA, the European Medicines Agency, hasn’t come down on kratom one way or the other, but the European Monitoring Centre for Drugs and Drug Addiction has a drug profile for it. In addition to its use as an opioid substitute and its narcotic sedative effects at high dosages, EMCDDA also notes the stimulant effects of a low dose.

Why Approval is Denied

The expressed reasoning for the FDA’s concern is that kratom has not been found to be safe by the FDA, and therefore shouldn’t be used. The same argument goes for cannabis, though not even the FDA suggests that cannabis has ever caused even one documented overdose death.

Why haven’t cannabis or kratom received FDA approval? Because the FDA only “evaluates research conducted by manufacturers.” It doesn’t conduct the research itself. In the absence of such research to evaluate, the FDA merely states that it “has not found any such product to be safe or effective for the treatment of any disease or condition.” That seems like circular logic.

High Cost of Testing

Just how much it costs to bring a new drug to market in the US is debatable. One oft-cited estimate put the figure at nearly $3 billion. (Another says $5 billion.) A more recent and much lower (but disputed) finding is $648 million. Forbes columnist Mathew Herper — who estimates the cost ranges from $10 million to $2 billion — says that the reason it is so high is that 90% of news drugs turn out to be not safe or effective, and those costs are included.

Marijuana’s and kratom’s questionable legality and Big Pharma‘s lack of interest make it difficult to raise the money to conduct the tests.

Big Pharma

If cannabis is as effective as opioids for chronic pain and other conditions, Big Pharma would like it still less, because it would diminish the market for their product. Even if they make more cannabis- or kratom-based products, they couldn’t charge as much for them as their opioids because people can get them from other sources.

Reasons why Big Pharma isn’t interested include:

  • It might not be possible to patent cannabis or kratom.
  • Big Pharma has its own synthetic marijuana-based products that already have FDA approval, including Marinol, Syndros, and Cesamet.
  • Legal marijuana and kratom might take away market share from their profitable opioids.

Solution

Some would probably prefer the market continue as is: Don’t enforce federal marijuana laws, don’t address whether kratom needs to be regulated as an opioid. The current quasi-legal, outlaw status quo would continue.

While that’s better than a ban, there are reasons why regulation and honest scientific study would be preferable:

  • There might be long-term problems with prolonged kratom or cannabis use. Rather than wait for the government to discover them and use them to ban them completely, discover them now and see if there’s some way to mitigate them.
  • Marijuana comes in different strains and strengths. Without regulation, users might not know how strong an effect a sample will deliver.

If governments and Big Pharma are unwilling to test marijuana, kratom and other off-the-books treatments, what is the solution? Make it easier for independent researchers to do the tests themselves.

Perhaps the government or some interested cannabis and kratom advocates can do what the Michael J. Fox Foundation, the Cystic Fibrosis Foundation, and the Multiple Myeloma Research Foundation have done: raise money for “early research costs” to prime the pump for Big Pharma, possibly spurring their interest in further research.

The opioid epidemic shows no signs of abating. A new report by Altarum finds that the opioid epidemic has cost the US $1 trillion since 2001, and could cost another $500 million in the next three years. Tightening of regulations and legal prescriptions have driven some people to more dangerous opioids such as heroin and fentanyl, sometimes unknowingly.

If kratom or cannabis is safer and effective, we need to find out, regulate them, and make them legally available.

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1 Comment

1 Comment

    WP_Comment Object ( [comment_ID] => 125575 [comment_post_ID] => 135584 [comment_author] => Kratom Keith [comment_author_email] => [email protected] [comment_author_url] => [comment_author_IP] => 162.158.63.206 [comment_date] => 2018-02-22 11:21:40 [comment_date_gmt] => 2018-02-22 11:21:40 [comment_content] => Excellent and truthful. The greed factor from #BigPharma is also a major factor. Why allow natural remedies when they can make a more dangerous synthetic version that does not work at all like the real plants? I believe Syndros is $2000 a month!! What do they expect when they gouge Americans for every single FDA APPROVED DRUG? People cannot afford these poisons that do not work as well! Wake up! [comment_karma] => 0 [comment_approved] => 1 [comment_agent] => Mozilla/5.0 (Linux; Android 7.0; SAMSUNG SM-G935P Build/NRD90M) AppleWebKit/537.36 (KHTML, like Gecko) SamsungBrowser/6.4 Chrome/56.0.2924.87 Mobile Safari/537.36 [comment_type] => [comment_parent] => 0 [user_id] => 0 [children:protected] => [populated_children:protected] => [post_fields:protected] => Array ( [0] => post_author [1] => post_date [2] => post_date_gmt [3] => post_content [4] => post_title [5] => post_excerpt [6] => post_status [7] => comment_status [8] => ping_status [9] => post_name [10] => to_ping [11] => pinged [12] => post_modified [13] => post_modified_gmt [14] => post_content_filtered [15] => post_parent [16] => guid [17] => menu_order [18] => post_type [19] => post_mime_type [20] => comment_count ) )
  1. Kratom Keith

    February 22, 2018 at 11:21 AM

    Excellent and truthful. The greed factor from #BigPharma is also a major factor. Why allow natural remedies when they can make a more dangerous synthetic version that does not work at all like the real plants? I believe Syndros is $2000 a month!! What do they expect when they gouge Americans for every single FDA APPROVED DRUG? People cannot afford these poisons that do not work as well! Wake up!

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