The Food and Drug Administration has refused to bow to demands to remove marijuana from its current Schedule I classification under the Controlled Substances Act 1970. However, the government does appear set to approve a prescription medication made from cannabis at some pint in 2018. The drug is called Epidiolex and it’s created by GW Pharmaceuticals. The medication is made with CBD, the non-intoxicating compound of cannabis, and it performed well during a study involving 170 patients with Lennox-Gastaut syndrome.
People with this condition suffer from severe epilepsy, and regular seizures are a symptom. The study showed that patients who used Epidiolex had 41% fewer seizures each month, and those on the placebo had a 14% overall reduction in seizures. Marijuana advocates know that CBD works for epilepsy ever since the famous case of Charlotte Figi. The question is, though, why will the FDA approve cannabis-based medication, but not the plant itself?
The obvious answer is data manipulation, and it is something that Big Pharma has been guilty of for generations.
The Pharmaceutical Industry & Published Clinical Evidence
Big Pharma has long been accused of undermining the truth about evidence from scientific trials in a case of profit over people. One of the most egregious cases of data manipulation occurred with the drug Vioxx, which was used to treat arthritis. Evidence that Vioxx doubled the risk of heart attack was available at least three years before the drug was finally pulled off the market.
The rate of heart attack with Vioxx was probably even higher because the trial did not include anyone with a known case of heart disease. Also, Vioxx was five times more likely to cause a heart attack than Naproxen, yet it was prescribed millions of times in Australia before it was finally removed. The delay probably had something to do with the fact that Vioxx generated $2.5 billion in 2013.
Paroxetine is another infamous drug which was dangerous but still approved by the FDA due to data manipulation. Between 1993 and 1998, GlaxoSmithKline (GSK) [then called SmithKline Beecham] provided $5 million to fund research into the drug. The study was led by a man named Martin Keller who received $800,000 for his troubles. Results from the study were published in 2011, and it concluded that “Paroxetine is generally well tolerated and effective for major depression in adolescents.”
However, it transpired that in all eight of GSK’s outcome measures (primary and secondary), the drug did not provide better results than a placebo. The article deleted the six secondary measures and replaced them with more favorable outcomes while misrepresenting one of the two primary outcomes to make it appear positive. Moreover, data from the study showed that at least eight adolescents had tried to commit suicide or conduct self-harm. Regardless, this information was left off the study, and some of the patients were classified as an ‘emotional liability.’
Big Pharma & Cannabis
That Big Pharma is finally looking to dig its talons into the medicinal marijuana industry is no big surprise. After all, these entities exist for the sole purpose of making a profit by any means necessary. Up until now, marijuana sales were a mere drop in the ocean compared to the remarkable profits generated by the pharmaceutical industry. Statistics from 2015 showed that the industry in the United States and Canada earned $515 billion, which is almost half of the entire world’s revenue share of $1.05 trillion.
With the marijuana industry’s value likely to exceed $20 billion in the next few years, plus the increasing numbers of states legalizing it for medicinal and recreational use, it was only a matter of time before Big Pharma jumped in to grab its share of the pie. The FDA has no problem bending over backward to allow synthetic, cannabis-based products from these companies to hit the market, while preventing natural treatments from becoming available for sale.
Now, the FDA doesn’t want to be accused of hypocrisy! Remember, marijuana apparently has no recognized medicinal use. So how can the FDA justify allowing cannabis-based synthetic drugs to be sold? Easy, it looks at the studies published, often with the financial backing of the company that’s selling the drug, and decides whether or not it is safe for the public. As you can imagine, Big Pharma is not above manipulating the data from its studies – after all, it has been doing it with other drugs for decades.
Data Manipulation & Profit
In August 2017, Zynerba Pharmaceuticals suffered a crushing blow after its synthetic cannabis-based gel, ZYN002, failed a mid-stage study. In a 188-patient study, it was determined that the gel didn’t result in a reduction in the frequency of seizures compared to a placebo. The company’s share price halved as a result of the news. Surely, this was the end of the gel?
Things got worse just a week or so later when another Phase-2 study on 320 patients with knee pain due to osteoarthritis, revealed that the gel offered no real relief compared to a placebo. By now, it appeared as if Zynerba was doomed. After the second failure, an end of Phase-2 meeting with the FDA was likely to make or break the company. Then, a ‘miracle’ happened.
In September, a tiny 20-patient mid-stage study on young people with autism spectrum disorder (ASD) found that the gel reduced anxiety, depression and other behavioral issues. The company’s stock rose 53% in a day on the back of the news, and the company’s CEO said the ‘clinically meaningful’ results should help Zynerba to “discuss the pathway to approval with the FDA” in 2018. Isn’t it amazing how the drug ‘suddenly’ became successful just six weeks after TWO failures? Also, while the failed studies involved hundreds of people, the ‘successful’ one involved just 20.
Final Thoughts on Big Pharma, Data Manipulation & Cannabis
While marijuana continues to be federally illegal, companies like Zynerba and GW Pharmaceuticals receive approval for cannabis-based synthetic products based on dubious data. The case of Zynerba is an especially unusual one – its cannabis-based gel was a disaster, and the company was in serious trouble. Miraculously, though, one small study had positive results and will likely end up paving the way for FDA approval of the drug. Given the industry’s history of data manipulation, forgive us for being very skeptical of the latest data from Zynerba, even if federal regulation might be a good thing for cannabis in the long run.