Tag Archives: FDA

The FDA is not holding back effective drugs

It’s going unnoticed amidst the news of the rolling disaster that is the incoming Trump administration, but our lame duck Congress has just passed a major piece of legislation called the 21st century cures act. Scientists are happy about the extra $5 billion this bill gives to the NIH – sort of. That money has to go to specific programs, like the Precision Medicine Initiative and Biden’s Moonshot program, rather than being put into the general funds of the NIH, meaning that Congress, and not the NIH, is deciding what specific research to fund. That’s generally not a good idea, but more money toward broad research and translational initiatives like cancer and precision medicine is still a net win.

More controversial are the FDA provisions of this bill. The bill pushes the FDA to take into account other, often less rigorous types of clinical studies when it decides whether or not to approve a new drug. Some worry that this means drug companies will have more leeway to push unsafe or ineffective drugs on the market. I’m more ambivalent – there are cases (drugs for rare diseases) when double blind randomized clinical trials may not be right, and the FDA should have the flexibility to demand the best evidence appropriate to each case. If – and this is a big if as we look ahead – we trust that the FDA can stand up to industry pressure, than giving them more flexibility to follow best scientific practices is the way to go.

My bigger problem with the FDA provisions are that the premise is flawed. As I write in Pacific Standard this week, the bill’s sponsors argue that, by cutting regulations and red tape at the FDA, we’ll free new cures that are just waiting to be put into the hands of patients. That’s wrong – the FDA is not the rate limiting step here. There is no backlog of effective new drugs just waiting to be approved.

Go check out my piece for the details. The rate limiting step is the science. Medical science is hard, and diseases are understood imperfectly. If you want more effective drugs faster, we need to invest more in research.

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When Supplements Work? “Sexual Health” dietary supplements like Viagra more than 60 year old investment bankers

The FDA has announced a voluntary recall of the “sexual health” (ie, erectile dysfunction) dietary supplement ACTRA-Sx 500 due to “adulteration” with the active compound from Viagra, sildenafil citrate. This is yet another recall of a “dietary supplement” that happens to be adulterated with a pharmaceutical that has been proven to treat the condition the supplement claims to address. This might make the supplement “work”, but it poses a real hazard to customers who are not permitted to know what they are taking. Continue reading

When Supplements “Work”. . .Light Headed, for the Wrong Reasons

Let’s say you have diabetes or heart disease and are taking nitrates for your condition. And, unfortunately, maybe you need a little more lead in your pencil, which is even more common with some of these conditions. Well your doctor might hesitate to prescribe the most common pharmaceuticals for erectile dysfunction, like tadalafil (Cialis) or sildenafil (Viagra), because these drugs taken in combination with nitrates can cause dangerously low blood pressure. So, in your desperation, you might think about reaching for one of those sexual enhancement supplements about which we all get countless emails. Continue reading

When Supplements “Work”. . .EZVille, Ltd – Where Health & Safety are Important-ish

The Universe is a funny place, full of bizarre coincidences. Like, for example, did you know that every single “dietary supplement” with an undeclared drug ingredient that we have covered in our When Supplements “Work”. . . feature so far has contained, among all the drugs in the world, a regulated drug that treats exactly the same condition that the supplement claims to treat? What are the odds?

This week we get a double whammy from EZVille, Ltd. EZVille, Ltd. has issued a recall of Revivexxx (one guess what that is supposed to “revive”) and Solo Slim. Revivexxx is a male sexual enhancement supplement (DSHEA code for treating erectile dysfunction), which was found to contain the erectile dysfunction pharmaceutical tadalafil (marketed using a series of creepy commericals under the brand name Cialis). Tadalafil is known to have potentially dangerous interactions with medications containing nitrates, such as those taken for heart disease. Solo Slim is a weight loss supplement, which was found to contain the appetite suppressant didesmethyl sibutramine. Sibutramine can increase blood pressure and heart rate putting individuals at risk for stroke and other cardiovascular issues at greater risk.

Individuals for whom tadalafil and sibutramine are not viable therapeutic options due to interacting medications or underlying medical issues may be more likely to seek out these alternative products to avoid side effects. The undeclared presence of these drugs in these supplements exposes these “at risk” individuals to these potentially dangerous side effects without their knowledge, unarguably a worse situation than if they had knowingly been prescribed these medications under the observation of a trained health care professional. Continue reading