We’ve been harping on Nexium for several years now. AstraZeneca’s (NYSE:AZN) supposed “healing purple pill” is nothing more than a dressed-up version of its previous blockbuster gastric reflux drug, Prilosec. We gave Nexium a Bitter Pill Award in 2005, the The Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag. Our members have been involved in several class action lawsuits alleging the Astra Zeneca deceptively marketed Nexium as an improvement over Prilosec, when in fact it is clinically no different. (As we’re fond of saying, the only difference between Nexium and Prilosec is that Nexium has yellow stripes and costs seven times as much).

We’ve always marveled at why Nexium is as successful as it is when Prilosec is available Over-the-Counter at a fraction of the price. The answer, of course is simple: Marketing. As we’ve written (see, for example “Top 3 Bestselling Drugs spent $460.5 Million on Ads in 2006″), Nexium owes its $4.3 billion in 2006 annual sales to the $176 million that Astra Zeneca spent that year on ads like this:

Now there’s even less of a reason for people to use Nexium instead of cheaper alternatives, including Over-the-Counter Prilosec. FDANews.com reports that Dexcel Pharma Technologies will soon begin selling a generic version of Over-the-Counter (OTC) Prilosec. Astra Zeneca sued Dexcel to prevent it from selling generic OTC Prilosec, but has settled that lawsuit with Dexcel.

Most people think of generics when they think about prescription drugs, not Over-the-Counter ones. But drug companies frequently get FDA permission to stop generic competitors for 3 years when a drug first becomes available over-the-counter. This is why up til now, you haven’t seen, for instance CVS or Walgreen store brand Prilosec.

Dexcel says that OTC Prilosec should be available by the end of March 2008. The competition between Astra Zeneca’s Prilosec and Dexcel’s generic version should drive the price down. This is yet another reason consumers don’t need to pay through the nose for prescription-only Nexium.

But even before you reach for that cheaper box of OTC Prilosec, you should consider whether even less expensive alternatives will do the trick — such as Tums, Zantac, Pepcid, and other over-the-counter heartburn drugs. Consumer Reports Best Buy Drugs has a report on heartburn medicines, and it says, in part:

If you suffer from only occasional heartburn and have not been diagnosed with GERD [gastric reflux disease], nonprescription antacids such as Maalox, Mylanta, Rolaids, and Tums, or acid–reducing drugs such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) will very likely provide relief.

Talk with your doctor about the role that dietary and lifestyle changes can play in alleviating heartburn, too – such as eating smaller meals, weight loss, and avoiding alcohol.

Today the FDA is holding a hearing on over-the-counter cough medicines marketed for use in children under 6. Our colleagues at the Prescription Project have issued a new report, Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children. The reports documents that the industry spends more than $50 million a year marketing cough medicines for children under 6, despite the lack of evidence that such drugs are effective for such children, and evidence that the drugs can present serious risks.
See coverage of this issue, and of the industry’s recent preemptive recall of a number of these medications approved for use in children 2 and under, here.

We here at the Prescription Access Litigation blog often lament the explosion of advertising for prescription drugs. But the huge spending on marketing of Over-the-Counter remedies is also troublesome. Over-the-Counter remedies are supposed to be safe enough for patients to take without a physician’s supervision. The disclosures that Over-the-Counter drugs have to make are, thus, much less than for prescription drugs. This lulls people into a false sense of security that if a drug is Over-the-Counter, it must be completely safe. Widespread marketing of these drugs only increases that impression. And marketing such drugs for use in children uses this belief to offer harried parents a quick fix for their children’s symptoms.

At the root of many of the problems caused by drug advertising, whether prescription or over-the-counter, is the shift in recent decades to thinking about medicines not as medical treatment but as a consumer product. But as we here are fond of saying — drugs are not like fabric softener or shampoo, and we treat like as such at our peril.

The FDA recently announced that it will hold a hearing on November 14, to consider whether to make certain drugs available only “behind the counter” — that is, without a prescription but only dispensed by a pharmacist. Presumably, this would introduce the intervention and consultation of a pharmacist, who could ask the patient questions to determine if the drug was really appropriate and advise them of alternatives if it was not. Many other countries have numerous drugs “behind the counter” that are Over-the-Counter in U.S. While we here at PAL don’t have a position on this proposed new status for drugs, it does seem that these cough medicines would be a good candidate if this status were created.

Below is the Prescription Project’s press release on the report, which you can find here.

The Prescription Project Report Shows Industry Spends $50 Million-a-Year Marketing Cough and Cold Medicines for Children Despite Evidence of Risks

Report says lack of results, risks for children under six does not deter drug company marketing of these products as “safe and effective.”

BOSTON–(BUSINESS WIRE)–The Prescription Project today released a report showing that companies producing over-the-counter (OTC) cough and cold medicines spent more than $50 million marketing these widely used products for children under the age of 6 despite evidence of risks and lack of effectiveness in treating children. The report, titled Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children, was released to coincide with today’s Federal Drug Administration’s Nonprescription Drug Advisory Committee hearing on the potential dangers of these products for children under the age of 6.

The Prescription Project report, which analyzed FDA, industry, and epidemiological documents on OTC remedies, shows a lack of efficacy data but a significant number of reported injuries and deaths associated with overdosing of these products. Manufacturers have heavily marketed this class of OTC preparations for many years based on their FDA classification as “safe and effective,” yet the FDA has not conducted or brought forward a single study or review to prove the safety or effectiveness of these products for use in small children in the last three decades. The full report is available at www.prescriptionproject.org.

“Especially when it comes to over-the-counter drugs, physicians and patients rely on the FDA to ‘calculate’ the benefits versus risks and communicate this to the public,” said John Santa, MD, MPH, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project (DERP). “In this case, it appears the benefits are close to zero while the risks are significant.”

Last week, in response to growing questions and pressure from pediatricians and the FDA, major manufacturers of the popular cold remedies announced that they were voluntarily withdrawing from the shelves OTC infant cold and cough products marketed for children age 2 and under. As of yet, there has been no action on drugs marketed for children 2-6 years old.

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and seeks to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, please visit www.prescriptionproject.org.