December 4, 2022

“Counterfeiters go where there is demand — and there is demand and there are access challenges,” said Libby Baney, senior advisor to the Alliance for Safe Online Pharmacies, an abortion pill market advocacy group. “That creates criminal opportunities and a major risk to patient safety.”

Google says it usually can’t determine when sites break the law, but will remove them from search results if the government asks.

Cytotec, the brand-name version of misoprostol, is an FDA-approved drug for the treatment of stomach ulcers. It is also one of two pills used to terminate a pregnancy. According to a statement from drug manufacturer Pfizer, Cytotec is a target for counterfeiters.

But in states where abortion is restricted, patients have reported problems getting prescriptions for issues unrelated to abortion.

Experts said people go online for medication when there is a barrier to getting it legally. In the case of abortion, those barriers can take the form of government regulations, as well as pressure from family, friends and community leaders to maintain a pregnancy. Other times, people turn to the Internet thinking they can get a drug at a lower cost.

While there are legitimate telemedicine operations and online pharmacies that help connect people online in states that restrict abortion, they sometimes struggle to promote their services. Illegal pharmacies, meanwhile, are adept at getting around Google’s rules and rising to the top of search results.

For example, there is a thriving online black market for Viagra, the erectile dysfunction drug, because people are too embarrassed to ask a doctor for it. Men seeking HIV prophylaxis sometimes go online if they don’t want to be seen at a sexual health clinic. During the pandemic, people have been purchasing hydroxychloroquine, a malaria drug touted by former President Donald Trump, and ivermectin, an antiparasitic drug, from shady websites, despite FDA warnings against its use.

“Any time you create a broken healthcare system or a broken supply chain, criminals will take advantage of that confusion,” said John B. Hertig, associate professor of pharmacy practice at Butler University College of Pharmacy and Health Sciences.

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An emerging black market

State laws restricting abortion already restrict access to drugs that can terminate pregnancies, even if a patient is taking them for other reasons.

Patients have complained that pharmacies don’t want to fill prescriptions for methotrexate, which is used to treat the immune disorder lupus and other diseases, but can cause miscarriage.

Although the Biden administration has told pharmacies that not administering medication to a patient is a crime, pharmacies may still be able to restrict access. Some allow individual pharmacists not to fulfill orders if they have conscientious objection. At least one state, Texas, active restricted providing abortions.

Price is also an issue. Rogue sites sell Cytotec for about $4 a pill, slightly below the normal cost per Drugs.com, a New Zealand pricing-tracking company. More than half of abortions in the United States are already caused by drugs, according to the Guttmacher Institute, a research group that supports abortion rights. That share is likely to rise after the Supreme Court ruling, creating a huge market to exploit.

Extra-legal but legitimate organizations have sprung up abroad to assist people with drug abortion in states where it is illegal. It can be difficult for individuals to determine which sites are safe.

“There is a majority of US consumers who believe that if they see medical care on the first page of Google, it has been vetted or validated by an authority in the US,” Hertig said. “And that is absolutely not the case.”

All of these issues create market opportunities for unauthorized online sellers.

Online searches for drug abortion skyrocketed after POLITICO published the Supreme Court’s draft opinion that preceded the overthrow of Roe v. Wade.

What they find is often labyrinthine. Of the approximately 35,000 online pharmacies worldwide, 95 percent operate according to the National Association of Pharmacy Councils.

“In our experience, these rogue pharmacies are master marketers and will target whatever drug is in the news and popular, and use it as a marketing tool to try and drive business to their website,” said David Khalaf, a spokesperson for LegitScript, an Oregon firm that validates online health services and works with government agencies and businesses to identify illegal operations.

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The enforcement problem

The pandemic provides a recent example of how an atmosphere of fear and confusion can give criminals room to operate. Between January 2020 and March 2020, scammers produced 190,000 domain names related to Covid-19, Dan Burke, senior operations manager at the FDA’s Office of Criminal Investigations, said during a June webinar on rogue pharmacies.

While scientists were still trying to understand the new virus, these sites were promising treatments. “We drank from a fire hose,” Burke said.

The FDA criminal investigators are responsible for tracking down illegal pharmacies and counterfeit drugs. It’s a tough assignment. Online drug dealers can hide their tracks and disappear in the blink of an eye. In addition, the office does not have the necessary enforcement tools to remove sites, especially when it comes to uncooperative domain registrars.

“You could anonymously register a domain name anywhere in the world and list pretty much anything on it — and good luck trying to shut that site down because you don’t know who runs it,” said Baney of the Alliance for Secure Online Pharmacies. .

The European Union imposed the General Data Protection Regulation in 2018 in an effort to protect the privacy of internet users. But the regulation also made it harder to go after fraudulent sites. Domain registrars, operating worldwide, stopped publishing the identities of website owners in order to comply. Now some domain registration services won’t pass information to regulators in the US without a subpoena and won’t remove illegal sites without a court order, Baney said.

The FDA has no subpoena powers and must instead rely on the Justice Department, which faces its own legal hurdles.

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“As a public health agency, we are in a catch-22 situation,” Burke said during the webinar. “We can’t show the scope of the network without subpoenas, but we can’t get subpoenas from the grand jury without showing the scope.”

Baney said that the Domain Reform for Unlawful Drug Sellers Act, a Senate bill introduced in December by Florida Republican Marc Rubio, seeks to hold domain registrars accountable. The bill would require a domain registrar to lock down and suspend a domain name associated with illegal behavior once the FDA or Department of Justice is notified.

Locking a domain name prevents the owner from transferring it to a new registrar and continuing operations.

The FDA also recently pressured the Internet Corporation for Assigned Names and Numbers, a nonprofit organization that oversees the larger domain name registration industry, to ensure that registrars meet accreditation requirements, including responding to reports of illegal activity. and abuse.

Consumers can inform themselves about what a rogue pharmacy might look like. According to the FDA, people should avoid any site that offers to sell drugs without a prescription. LegitScript also has a domain checker on its website that can check if a site is legit. Plan C, a project of the National Women’s Health Network, provides a list of vetted sources for abortion pills.

Baney would like to see search engines take more responsibility. “The algorithm is controllable,” she said. “You could prioritize legitimate, licensed suppliers and online pharmacies.”

A Google spokesperson said the company aims to place high-quality sources at the top of search results and remove rogue pharmaceutical websites from its results when the FDA determines they are breaking the law and asks Google to do so.

Still, the rogue sites are finding a way, and patients should proceed with caution, Hertig said. “If you’re a patient who’s having a hard time because they can’t find access to care right now, whether it’s abortion or whatever, it’s natural for them to google it, and that’s a very risky proposition.”