All drugs go through a rigorous process to gain approval by the Food and Drug Administration — except cannabis, which Americans seem to be giving a free pass.
There’s no high-quality evidence that smoking cannabis is any better than FDA-approved products for certain ailments.
While patients die waiting for other drugs to work their way through stringent testing processes, cannabis is somehow able to bypass the entire FDA process. Medical marijuana is now available in 24 states and Washington, D.C., to “treat” an array of conditions and diseases.
Experts warn about using the drug because there is a lack of credible evidence that it works. The public as well as public officials seem OK in neglecting that evidence — or the lack of it.
People dying of cancer, for example, generally have to wait years for potential drugs and treatments to go through the FDA process. But other people with just as horrific ailments — many of them not facing imminent mortality — don’t have to wait for the process to work in order to use cannabis.
What is going on?
Under the FDA’s extended access, or compassionate use designation, patients can seek authorization to access drugs that are in the midst of the FDA approval process. The FDA, in fact, recently gave “breakthrough” status to a brain cancer drug that uses the polio virus to attack cancer cells — something that could fast track the drug’s approval and adoption.
In the case of cancer drugs, pharmaceutical companies may have the possibility of accelerating drug approval and patients may be able to use a drug in the process of FDA approval. But they can’t bypass the FDA and legislate their way to drug use.
Yet cannabis did.
It’s illegal to sell any drug that is not FDA-approved in the U.S. — except in 24 states, where medical marijuana is for sale.
[lz_bulleted_list title=”Drug Approvals in U.S.” source=”http://www.medicinenet.com”]New drugs take an average of 12 years from lab to market.|Only 5 in 5,000 drugs ever get to human testing.|Only 1 of every 5 drugs tested in humans is approved.|Costs topped $2.5 billion in 2014 to bring new drugs to market.[/lz_bulleted_list]
“Cannabis is the only thing that’s been approved for medical use by legislation rather than the traditional drug or device development process overseen by the FDA,” said Dr. Ryan Vandrey, an associate professor at Johns Hopkins Bayview Medical Center in Baltimore, Maryland.
“That just puts it in a very unique category,” Vandrey said.
“On one hand, you can say cannabis is a known entity. It exists and is available to people even without approval,” Vandrey said, adding that its presence — compared to a drug produced in a lab — gives it a unique property that seemed to make legislation pass more quickly.
There are approved medicines based on cannabinoids. Dronabinol, or Marinol, is synthetic delta-9-tetrahydrocannabinol, which is a naturally occurring component of cannabis. Nabilone, or Cesamet, is a synthetic cannabinoid.
Marijuana supporters argued that the whole plant has fewer side effects compared to certain components, Vandrey said. While there’s some data to support that, there’s no data to support that the use of it is as safe as other approved drugs.
Dr. Arthur Robin Williams, a psychiatrist at Columbia University who studies marijuana, said legalization of a drug instead of FDA approval is an “unprecedented phenomenon.” With regard to conditions people are “treating” with medical marijuana, there is no high-quality evidence that smoking whole-plant cannabis is any better than FDA-approved products for those ailments, he added.
Vandrey said people came out in droves to support cannabis, which softened the hearts of lawmakers. “Out of compassion for their constituents, they passed the law,” he added.
Dr. Bertha Madras, a professor at Harvard Medical School’s McLean Hospital, said states approved medical marijuana because several billionaires sponsored legislative initiatives, media campaigns, and political efforts to convince the American public to vote on what is and is not a medicine.
“The process was designed to circumvent the FDA,” Madras said. “If they had spent over $100 million on clinical trials instead of politics, our nation and the world would have been much further along in assessing the therapeutic potential of cannabinoids.” He added, “Now 24 states are engaged in human experiments without informed consent.”
With approved drugs, the federal government oversees manufacturing and labeling standards. Such is not the case for medical marijuana.
“They don’t have that authority for cannabis because they have to pretend it’s not available,” Vandrey said. “By leapfrogging the FDA … they’re skipping the research that usually informs those things” — something Vandrey said is a “critical flaw.”
Cannabis is still an illegal Schedule I drug, according to the DEA.
As a result, there’s no control over what is being sold to patients. The product can be contaminated or inaccurately labeled. “From a patient safety perspective, that’s a big issue,” said Vandrey.
It also presents challenges for doctors — they’re unsure which conditions it can treat and what doses are acceptable. There’s no data available on which patients would be good candidates — no information on how patients may respond. But because the federal government stalled on researching medical marijuana, the states took control. Now the country is missing evidence on its possible medicinal uses.
“It’s clear the consensus is that cannabis has therapeutic benefits,” Vandrey said. He expects more states to pass their own versions of laws — and not many will be based on science.
Though approved by some states, cannabis is still an illegal Schedule I drug, according to the Drug Enforcement Administration.
Vandrey he believes research is the only way forward, that the country must play catch-up on research so doctors have quality data to better understand it.
“The problem and issue with cannabis is this: People put it up on a pedestal as if it’s something unique, and it shouldn’t follow the same rules,” Vandrey said. “We should treat it just like everything else.”