Megan Fox Is Stalking Me

Megan Fox won’t leave me alone.

She's on my phone. She's on my TV. And she's following me all over New York City, staring down at me from ads seemingly everywhere I go.

For the past few weeks, I've been bombarded with advertisements featuring the actress promoting a new erectile dysfunction treatment called Ro Sparks. As a heterosexual man, I can appreciate the marketing strategy. As a pharmacist, I have some questions.

Ro Sparks is a prescription medication sold through the telehealth company Ro. It combines sildenafil, the active ingredient in Viagra, with tadalafil, the active ingredient in Cialis, into a single dissolvable tablet. The pitch is that men can get the fast-acting benefits of Viagra with the longer-lasting effects of Cialis.

It's an appealing proposition. Two of the most recognizable erectile dysfunction drugs in history, combined into one convenient product. Add Megan Fox, a slick advertising campaign, and the promise of a better sex life, and you've got yourself a nice business.

There's just one problem. We don’t know if Ro Sparks is safe.

And the more I looked into it, the more questions I had about how a product like this gets marketed to millions of Americans in the first place. 

Let's start with the medicine.

Sildenafil and tadalafil belong to the same class of medications, called phosphodiesterase type 5 inhibitors, or PDE5 inhibitors. They work by relaxing blood vessels and increasing blood flow to the penis, making it easier to achieve and maintain an erection.

Both are FDA-approved, widely prescribed, and generally considered safe and effective when used appropriately. They've also been available as inexpensive generics for years.

But they are not identical.

Sildenafil typically starts working within 30-60 minutes and lasts for approximately four hours. Tadalafil takes a little longer to reach its peak effect but can remain effective for up to 36 hours.

Ro's idea is to combine the two into one medication that supposedly offers the best of both worlds.

Generally, the starting dose for sildenafil is 20mg and for tadalafil is 5mg.

Ro Sparks contains 55 milligrams of sildenafil and 22 milligrams of tadalafil.

That's an eyebrow raising combination, particularly because these drugs work through the same mechanism. Combining them can increase the risk of additive adverse effects, including headaches, flushing, dizziness, low blood pressure, and of course, those infamous 4+ hour long erections. 

As a pharmacist, if a patient told me they were taking Viagra and Cialis together, I would have some immediate follow-up questions. I certainly wouldn't recommend combining them casually.

So I went looking for the clinical evidence supporting this particular combination.

And I didn't find much.

There is a published clinical trial involving 180 men with erectile dysfunction that evaluated tadalafil 5 milligrams daily, with or without sildenafil 50 milligrams as needed. The researchers found that combination therapy improved erectile function in certain patients, particularly those with severe ED, without a statistically significant increase in reported adverse events.

That's worth acknowledging. There is at least some evidence that combining these medications may be beneficial in selected patients.

But that study did not evaluate Ro Sparks.

Ro Sparks contains 22 milligrams of tadalafil in a single dose, compared with the 5-milligram daily regimen used in the trial. That's 4.4 times the tadalafil amount per administration, although the different dosing schedules make a direct comparison of total drug exposure more complicated. It also contains 55 milligrams of sildenafil rather than 50.

The study involved only 180 patients, and it did not evaluate Ro's particular formulation, dose combination, or method of administration.

In other words, it's a long way from the kind of comprehensive evidence that would ordinarily support FDA approval of a new combination drug.

I'm not claiming that Ro Sparks has been proven dangerous. But I am saying that its specific safety and effectiveness have not been established through the FDA approval process.

Those are two very, very different things.

And one of them seems rather important when you're asking millions of men to put something in their bodies

I've written quite a lot about America's unusual relationship with pharmaceutical advertising.

The United States is one of only two countries in the world that allow direct-to-consumer advertising of prescription drugs. For decades, pharmaceutical companies have spent billions convincing Americans to ask their doctors about medications they saw on television.

There are rules governing these advertisements, including requirements around truthful claims and communicating important risks.

We've all seen the commercials. A couple holding hands on a beach while a narrator rattles off a list of potential side effects that sounds considerably worse than the disease being treated.

It's become such a familiar part of American life that most people barely notice it anymore.

But Ro Sparks occupies a different regulatory category.

The product is compounded, meaning it is prepared under a legal framework that allows certain medications to be customized for individual patients rather than approved and manufactured as conventional commercial drug products.

Compounding is an important part of pharmacy. I've worked in this profession long enough to appreciate why it exists. Sometimes a patient needs a dosage form, strength, or ingredient combination that isn't commercially available. Compounding allows pharmacists and prescribers to address those specific needs.

What it was never intended to become, in my view, is a convenient substitute for the traditional drug approval process whenever a company wants to create a new national pharmaceutical brand.

Yet that's increasingly what the industry looks like.

Ro can advertise a branded compounded treatment to consumers, but that treatment has not undergone the FDA's review for safety, effectiveness, and quality that an approved drug would.

And while compounded drug advertising is still subject to laws prohibiting false or misleading promotion, the regulatory framework is not identical to the familiar advertising regime for FDA-approved prescription drugs.

Watch the Megan Fox advertisements closely.

The celebrity, the sexual imagery, and the promise of improved performance are impossible to miss. The disclosure that the product is not FDA-approved is considerably easier to overlook.

I find that fascinating.

We've spent decades teaching consumers that pharmaceutical advertising is part of a heavily regulated industry. Now companies can borrow the visual language and credibility of that industry to promote products that haven't undergone the same approval process.

The disclaimer might technically be there. But does the average person watching Megan Fox on television understand what it actually means?

I suspect most don't.

And I don't think that's an accident of modern advertising.

My curiosity eventually led me to Ro's website, where I started digging through the product information.

What struck me was how little of the safety material appeared to address the actual combination being sold.

The safety page I reviewed provided information about sildenafil and tadalafil individually, including warnings and adverse reactions associated with the two medications.

That's useful information, of course. But knowing the safety profiles of two drugs separately is not the same as knowing the safety profile of taking them together in a new formulation.

I wanted to see clinical trials evaluating Ro Sparks itself. I wanted to understand what evidence supported its specific dosing and the claims being made about how quickly it works and how long its effects last.

I couldn't find that evidence anywhere.

One detail was particularly amusing.

Ro's website acknowledges that its compounded product has not been evaluated or approved by the FDA. Yet its safety information directs consumers to report adverse events to the FDA.

There's nothing inherently improper about that. The FDA collects adverse-event reports for unapproved and compounded drugs, too.

Still, the contrast is remarkable.

The FDA hasn't approved the product, but it's apparently still available to help clean up the paperwork if something goes wrong.

I would love to know what clinical data Ro relied upon when developing this combination, and whether the company has conducted any product-specific studies that aren't publicly available.

Because from where I'm sitting, it looks like a company has taken two inexpensive generic drugs, combined them into a proprietary product, and built an enormous marketing campaign around the result without publicly providing clinical evidence establishing the safety.

Which raises an obvious question.

Why?

To be fair, Ro has done something genuinely valuable.

Erectile dysfunction is common, often embarrassing, and frequently undertreated. Telehealth has made it easier for men to discuss sexual health, obtain legitimate prescriptions, and access medications without the discomfort of an in-person appointment.

I support that.

But sildenafil and tadalafil are already available as inexpensive FDA-approved generics. They work extremely well for many patients. Physicians have years of clinical experience prescribing them, and we understand their benefits, limitations, and risks.

So what unmet medical need does Ro Sparks actually solve?

Perhaps there are patients who benefit from combination therapy. Perhaps some men prefer a dissolvable formulation. Those are reasonable possibilities.

But there's another explanation that deserves consideration.

You can't build much of a proprietary pharmaceutical empire around generic Viagra that patients can buy cheaply at almost any pharmacy.

You can, however, build a brand around a distinctive combination, give it a memorable name, and hire beautiful celebrities to sell it.

That's the part of this story that feels particularly familiar.

I've written before about the commercialization of peptides, compounded GLP-1 medications, and testosterone therapy. Different products, different audiences, but the business model often looks remarkably similar.

Identify a health concern. Make treatment feel like a lifestyle upgrade. Remove friction from the purchasing process. Turn a prescription into a recurring consumer relationship.

None of that automatically makes the treatment inappropriate.

But it does create a powerful financial incentive to prioritize customer acquisition over clinical necessity.

And when a company is spending heavily to convince consumers that they need its particular version of a medication, I think it's reasonable to ask whether the product was developed to meet a medical need or a marketing opportunity.

This is the question that bothers me most.

Imagine a 25-year-old guy who has seen the same advertisements I have. He doesn't necessarily have a diagnosed medical condition. Maybe he's experiencing occasional performance anxiety. Maybe he's simply curious.

He clicks the advertisement, completes an online medical questionnaire, and requests Ro Sparks.

A licensed clinician reviews his information and determines whether a prescription is appropriate. A compounding pharmacy prepares the medication, and the product arrives at his door.

Everything might work perfectly.

But what happens if it doesn't?

What if he fails to disclose another medication he's taking? What if he has an underlying cardiovascular condition? What if he experiences a serious adverse reaction?

Who is responsible?

Ro created the product offering, controls the marketing, and brought the customer into the system. A clinician made the prescribing decision. A pharmacy compounded and dispensed the medication. And the patient provided the medical information on which that decision was based.

Each party has real legal and professional responsibilities. A prescription doesn't automatically shield the company marketing a product, and an online consultation isn't inherently inferior to an office visit.

But who is responsible for making sure the entire system is designed around the patient's safety rather than the efficiency of the transaction?

I don't know enough about Ro's internal prescribing protocols to judge their adequacy. I would want to know how clinicians screen patients, how medication interactions are identified, and what follow-up occurs after treatment begins.

These aren't unreasonable questions. They're the kinds of questions I ask myself every day while running a pharmacy.

When someone walks into C.O. Bigelow with a prescription, my pharmacists and I have to consider more than whether the medication can be legally dispensed. We have to consider whether it makes sense for that particular patient.

And if something seems wrong, we have a responsibility to intervene.

I worry that in our increasingly fragmented healthcare system, we've become very good at distributing tasks among different businesses without establishing who is ultimately accountable for the patient's experience.

Everyone handles their part of the transaction.

The patient is the only one who has to live with the outcome.

This isn't an entirely hypothetical regulatory concern.

In March, the FDA announced warning letters to 30 telehealth companies over allegedly misleading marketing of compounded GLP-1 medications.

Among the agency's concerns were advertisements that implied compounded medications were equivalent to FDA-approved products and branding that obscured who was actually producing the drugs.

The FDA was explicit that compounded medications do not undergo the same premarket review as approved drugs.

Those enforcement actions involved different products and do not establish that Ro has violated any law.

But they demonstrate that regulators are beginning to confront the larger issue.

What happens when a system designed to allow individualized pharmaceutical compounding becomes a vehicle for mass-market drug commercialization?

There is a legitimate place for compounded medications in American healthcare. There is also a legitimate place for telehealth, consumer-friendly medical services, and even pharmaceutical advertising.

I don't believe any of those things should disappear.

But combining them creates a business model that our regulatory system was not necessarily designed to anticipate.

And when the product being marketed is a prescription drug combination without FDA approval, I think the burden should be on the company to explain why patients should have confidence in it.

Not on consumers to figure out what the fine print means.

I don't begrudge anyone who wants to improve their sex life. And I certainly don't think men should feel embarrassed about seeking treatment for erectile dysfunction.

If Megan Fox convinces someone to finally discuss a legitimate medical problem with a qualified clinician, wonderful.

But I worry about what happens when the same marketing machinery that sells us sneakers, skincare, and supplements becomes the dominant way Americans discover and obtain prescription drugs.

The consumer sees a celebrity. The company sees a customer. The clinician sees a medical questionnaire. The pharmacy sees a prescription.

Somewhere in that process, we need to make sure someone is still seeing a patient.

Because the point of FDA approval isn't to make pharmaceutical companies miserable. It's to require evidence before companies make medical promises to the public.

Compounding has an important role precisely because medicine cannot always be reduced to commercially available products. But that flexibility shouldn't become a shortcut around the scientific standards we've spent decades developing.

I don't know whether Ro Sparks will eventually be shown to be a safe and effective treatment for a particular group of patients.

Maybe it will.

I'd simply prefer to see the evidence before the national advertising campaign.

In the meantime, I never thought I’d say this, but…

Megan Fox - please leave me alone!

Alec Wade Ginsberg, PharmD, RPh
4th-Gen Pharmacist | Owner & COO, C.O. Bigelow
Founder, Drugstore Cowboy