Well, faster than a speeding bullet, the FDA is on the verge of approving a new drug, one of the new class of PCSK9 inhibitors, to lower that bad, bad LDL-cholesterol. Of course, like the statins, they will not change the heart health issues of the world, save lives or do anything remotely useful. Oddly, the FDA was more cautious with this drug than they were with the statins which were approved with very little human data, and with data from dogs showing that they were lethal because of low safety margins. Perhaps, the FDA learned something, though I doubt it.
FDA approval for the statins came about so quickly because the board that recommended that the first statin to obtain approval, was loaded with people from the drug industry! The very same people who were in the statin making business. Over concerns by many medical experts to delay approval, statins arrived on our doorsteps in no time and became the biggest selling drugs in history. Now, we could be about to embark on a similar journey.
Here is the announcement From the company, Sanofi:
GAITHERSBURG, Md. – Federal health advisers are recommending approval for a highly-anticipated cholesterol drug, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.
A panel of experts recommended voted 13-3 to recommend the Food and Drug Administration approve Sanofi and Regeneron Pharmaceutical’s injectable drug.
But in a surprising development, a number of panelists said the drug should only be used in patients with abnormally high cholesterol levels caused by an inherited disorder. Before it is used more broadly, most panelists said they wanted to see more data about whether the drug ultimately reduces heart problems.
The drug is part of an experimental class of medicines that lower cholesterol more than statins, the older medications that have been the standard treatment for more than 20 years.
You have to read the last line over and over. An experimental class of medicines—
Now look at the fuss that was made over ‘Peptides’ many of which had over 15 years of use in humans and very few side-effects and a wide margin of safety. As you have probably figured out, the ‘concerns’ by the FDA, TGA etc are motivated by industry pressure to keep competitors that are safer and cheaper off the market for as long as possible. Hence, the cry ‘for more studies’ whenever competition rears its ugly head. That way the Big Boys can peddle their wares unmolested.
Now compare that stance to the clear meaning of the last line of the news article. Experimental is perfectly alright if you are Big Pharma, allowing you to experiment on the public while making massive profits. The estimated cost per year of these drugs is about US$10,000 per patient.
Also, much of the fuss about using peptides was that many of them have to be injected, the implication being that if something is injected, it is more potent or dangerous. Actually it means that oral and transdermal aren’t as effective a means of getting the drug into the body. That’s why insulin, so far, has to be injected.
Largely untried, unsure of their safety and efficacy, PCSK9s will flood the market in the next year or two and the humans who are prescribed these drugs will be the test vehicles — by a drug that has to be injected every 2 to 4 weeks.
MY advice – refuse to buy into the cholesterol argument because it has been proven to be bogus (see blog below) and absolutely refuse to inject yourself with something by a company that is using you as a test case. Don’t say I didn’t warn you.
Here’s an update. The FDA has been recommended another PCSK9 inhibitor to consider for approval in the next couple of months. Again, note the caution being expressed: The trials so far have been short-term, and it’s not clear whether the new cholesterol drugs really do extend people’s lives, Seth Martin, M.D., a cardiologist at Johns Hopkins University in Baltimore and coauthor of an editorial published with the study, told HealthDay.