I was recently required to take a brief REMS (Risk Evaluation and Mitigation Strategies) course about the coming drug, Addyi, meaning that pharmacists will be asked to be the gatekeepers of any post marketing risks that arise. It asks pharmacists to have patients vow not to use alcohol while taking Addyi. At all. Ever. Good luck with that.

Quite a few things have come to light since my August 27 blog that criticized the approval of Addyi, the female sex pill.

More recently, an independent agency called the Project on Government Oversight (POGO) found that FDA has erred in approving the blood thinner, Pradaxa. Pradaxa was touted as an alternative to warfarin that does not require the close monitoring of clotting time. Although technically true, another critical difference between Pradaxa and warfarin is that if a patient is bleeding because of a too high warfarin level, vitamin K can reverse the problem quite quickly. Pradaxa has no such counter measure or antidote and patients have been bleeding to death as frustrated doctors could only try to pump new blood in fast enough to save the patient. Some of this was published in NEJM in 2011.

So what the heck is going on here? The list of drugs making it to market only to be discovered to be way more dangerous than originally thought continues to grow. Part of the reason may be the FDA Modernization Act of 1997. That was supposed to streamline the FDA and was easily passed despite an attempt to filibuster (by Edward Kennedy, no less) its failure. One thing that Act did was to reduce the number of clinical trials required to establish the safety and efficacy of a drug from two or more to one or more. Clinical trials have been the standard of proof for decades and should rely on sound scientific method to yield reproducible results. A single trial is an inadequate measure. I remind you of the Addyi study on alcohol use with the drug. A single study heavily weighted with men for a drug to be used exclusively by women, with worrisome results, did not prevent FDA approval. About a third of new drug approvals have been based on a single study, with an average of about 750 patients per study. Not exactly robust.

We now have before Congress, the 21st Century Cures Act. Boy doesn’t that sound impressive. Of course, so did modernizing the FDA back in 1997. Guess what. The “streamlining” continues. Have a look at some of the language found in the summary of H.R. 6 – 21st Century Cures Act found on congress.gov:

Section 1001 reauthorizes funding the NIH through fiscal year 2018 – that’s good, likely to be about 3% increase in NIH funding. Let’s read on though…

1023 “The NIH must reduce the administrative burdens of researchers funded by the NIH” – to me that sounds an awful lot like “the NIH will stop watching so closely and stop demanding all that pesky documentation.”

1081 “The Pediatric Research Initiative is revised to require establishment of a National Pediatric Research Network comprised of pediatric research consortia.” – Gee, I wonder who this consortia will be?

1141 “The Council for 21st Century Cures, a nonprofit corporation, is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.” – Shazam! A new nonprofit corporation! Pick me! Pick me!

2001 “This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the FDA to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.” Why bother with a clinical trial? Just ask Aunt Sally and brother Billy how they liked the drug. Are YOU experienced? This is a scary amendment folks.

2061 “The FDA must issue guidance that addresses using alternative statistical methods in clinical trials and in the development and review of drugs.” – Makes me think of Mark Twain’s 3 types of lies; lies, damn lies, and statistics. Now we can add alternative statistics because it is too easy to detect manipulation of current statistical analysis.

2263 “Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards.” So, depending on who gets to define “minimal risk” and “safeguards,” we may be unknowingly subjected to clinical testing of drugs or devices. “Trust us, it’s better if you don’t know…”

4041 “The Cures Innovation Fund is established and funding is appropriated to carry out specified provisions of this Act.” – what the summary does not tell you is that this section requires the Secretary of Energy to draw down and sell oil from the strategic reserve. The money from those sales will flow into the General Fund though, so funding the Cures Act is not directly supported. Proponents of the Cures Act say that this Innovation Fund will be backed by $2 billion per year for 5 years. Show me the money.

There’s plenty more in there to worry about and I want to make sure you will stay awake for these observations:

Our wonderful democratic process that created watchful, protective entities like the FDA has been compromised to such an extent that we now need a watchdog agency like POGO to tell us that the government agency meant to protect us is really serving the desires of the companies that they should be regulating! Pharma is not alone in this assault on our democratic principles. Much of Congress answers to the plutocrats of the American oligarchy and the people are left unrepresented. What more could you expect when our Supreme Court has deemed corporations to be people and money to be free speech?

I love the POGO acronym mostly because I am old enough to recall the Pogo comic strip and the phrase it popularized; “We have met the enemy and he is us.”

The CEO of Valeant Pharmaceuticals, the company that bought the developer of Addyi, Sprout, two days after its approval has clearly stated that when “products are sort of mispriced and there’s an opportunity, we will act appropriately in terms of doing what I assume our shareholders would like us to do.” Just in case you had any doubt that Big Pharma is more about profit than medicine. Valeant has raised the prices on several drugs under current leadership, as much as 800%. Addyi will cost about $350 a month for questionable results accompanied by significant risks. Watch for the advertising, THAT should be fun.

The candidates are debating, the money is flowing, and we are heading into another year of muck and mire in our political cycle. It behooves you to pay attention. Our president cannot run again, but many of our Congressmen are up for reelection so be sure they have represented YOU before you vote blindly to keep them in office. Take the time to be informed.

Pharmacists. I talk to more and more colleagues on the front lines that are helping patients identify unnecessary drugs and suggesting lifestyle and dietary changes. If done properly, the patient can only benefit. We know drugs that are overused, barely therapeutic, or easily replaced by a low cost alternative. Don’t be afraid to intervene. You don’t need MTM appointments to make a difference in your patients’ lives. Use the mother test; “What would I do if this was my mother?”

The 21st Century Cures Act contains many wonderful ideas to modernize medical care and it may have started out as an altruistic attempt to improve health care. I fear, though, that like much of our legislation these days that it has been amended and tinkered with at the behest of industry lobbyists and other special interests to the point where many dangerous changes may be implemented if this thing passes the Senate and gets signed into law. If we the people let that happen then we are indeed our own worst enemy.