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The Corporate Influence

December 12, 2012

Ritalin (Photo credit: Wikipedia)

There was one article that really stood out to me in today’s Daily News, as it strikes a chord on a topic that I already feel rather strongly about. The first article in the opinion section refers to a recent federal appellate court ruling which should make us all stand up and take notice.

As background, the sale of pharmaceuticals and other health aids is regulated or at least impacted by the Food, Drug, and Cosmetic Act, passed in 1938 which, among other things, gave the FDA authority to approve pharmaceuticals for sale to the general public. This power was granted in response to the ill effects of so-called “cures” such as:

  • Banbar, used for diabetes patients which had none of the healing properties of insulin treatment;
  • Radithor, a form of radiation therapy which led to many slow and painful deaths;
  • Elixir Sulfanilamide, used as an antibiotic and marketed to pediatric patients, which used a toxic solvent to dissolve the drug.

Under the FDCA, companies were required to submit proof of therapeutic efficacy and safety to the FDA prior to marketing and selling any new drugs. It also specifically prohibits marketing pharmaceuticals for any use other than that it is explicitly approved for. In other words, a blood pressure medication may not be marketed as a remedy for heartburn without first obtaining explicit approval for that separate treatment. This regulation makes good sense, as it is designed to prevent companies from making claims about untested cures with potentially significant side effects.

All of that may have just been thrown out the window. The 2nd Circuit Court of Appeals, with jurisdiction of New York, Vermont, and Connecticut, has ruled that the government essentially cannot enforce the provision restricting marketing of a drug based on its approval. The court threw out the conviction of a pharmaceutical drug rep for promoting a drug’s off-label uses, stating that “the government cannot prosecute pharmaceutical manufacturers and their representatives for speech about a product.

Now, to be fair, the court limited its ruling to preventing this enforcement of the off-label uses of FDA-approved drugs. Off-label uses essentially are those for which the drug may not have approval, but does have effect. For example, using the above instance of a blood pressure medicine, if it is also found to treat erectile dysfunction (aka Viagra), then a doctor is allowed to prescribe it “off-label” as long as it is not specifically prohibited (known as “contraindicated”) for that use. The most common example would be prescribing a higher or lower dose depending on the age of the patient. A pharmaceutical company, however, cannot promote such off-label uses. In this case, a drug rep was convicted of promoting a narcolepsy drug for use in treating insomnia and fibromyalgia.

This ruling is another in the string of absurd logic which somehow equates corporations as having rights to speech which cannot be regulated. In the famous case of Citizens United, this viewpoint led directly to the most expensive campaign in history. In this case, what the court has essentially said is that as long as a drug is FDA-approved, a company or sales rep can market its use for anything, as long as that use is not directly prohibited. (Note: contraindication is normally very narrowly defined). If we continue down this path, we will end up where we were in the unregulated 1800’s, when companies promoted products such as Lash-Lure, which caused numerous instances of eye damage and at least one case of permanent blindness.

The US already has some of the most lax regulations on pharmaceutical advertising, being one of only 2 countries in the world to allow direct-to-consumer (DTC) advertising of pharmaceutical products (New Zealand being the other). A study published in the Canadian Medical Association Journal found that DTC advertising greatly increases the probability of a patient requesting a medication and of that medication being prescribed, even if the doctor is less than sure it is the right choice. This finding despite the fact that the best answer to most of these problems is a lifestyle change (I’m looking at you, “Restless Leg Syndrome“), and the medications prescribed usually have an awful list of side effects.

What has been completely overlooked in this ruling is the impact to the safety of the public. This completely free market approach to drug regulation puts the burden of treatment not on the company, but on the patient. And when you have a potentially life-threatening condition, the last thing you should have to worry about is whether or not the prescription you have gotten is for a medication that will work safely.

I guess I shouldn’t be so upset, though. I mean, think of the new business opportunities. In fact, I have just discovered a new miracle drug which can cure headaches, settle upset stomachs, even eliminate cancer. This miracle drug? Aspirin! (Hey, it’s FDA-approved, so it must be good).


From → Opinion

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