Envisioning 2.0

Over the past few years, the pharmaceutical industry has waged very public battle to prevent a mass influx of drugs from Canada and other nations. The industry’s argument is that drugs imported from other countries are unsafe for Americans.

In addition, government agencies like US Customs and the Food and Drug Administration (FDA) have not supported importation. In fact, Customs has seized tens of thousands of packages containing Canadian drugs at the border.

Yesterday there was a new twist in the debate. In an announcement, the FDA warned the public not to purchase medications sold by online pharmacies with orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health. The agency has found that these firms provide counterfeit medications. These companies are based in Canada.

Mark Senak, who writes the blog Eye On FDA was a little puzzled by this announcement, saying: “[Last year] the Pharmaceutical Security Institute noted that there were 10 countries with growing counterfeit problems. Canada was not among the top 10. The United States was.” He warns that we should not take the FDA’s announcement out of context. Counterfeit drugs are a problem in the US as well.

Despite the clamor about the dubious safety of drug importation, Americans are not buying it. According to a poll released today by Harris Interactive (available at the Wall Street Journal Website, subscription required), most Americans strongly support importing medications from Canada and other countries Moreover, 77 percent of those polled believe that the pharmaceutical industry’s policies on this topic are unreasonable.
Drug firms are losing the battle of hearts and minds on the issue of drug importation. Americans believe that medications from Canada are safe despite highly publicized seizures and warnings from the FDA. They simply want cheaper medications.

Clearly, the industry must do a better job of showing people the value of prescription drugs. In addition, I don’t think that people understand or accept drug firms’ explanations about:

- Why medications in the US are more expensive than those found overseas

- Why Health Canada (the FDA’s counterpart in Canada) is less capable of vetting the safety and efficacy of medications than the FDA

This is a very difficult communications and perceptual problem to solve. If the industry wants to convince people that drug importation is not safe it will have to try new tactics. The old ones are not working.

A couple of quick notes about the continuing Plan B story this morning.

First, John Mack over at Pharma Marketing Blog takes a look at how Barr might leverage the Internet to market Plan B to consumers. He mentions that the company may engage in “behavioral targeting” to advertise the product to potential users. I’ve discussed behavioral marketing here, which has many pitfalls. Still, Mack’s idea is interesting and deserves some thought.

Second, the New York Times reports that Barr does not expect Plan B to be a blockbuster. It will earn about $60 million at best. Barr says that producing the product will solidify its reputation in women’s health. An analyst scoffed at this notion, saying that most women won’t know where they are getting the product from.

Could producing Plan B do good things for Barr’s reputation? It’s hard to say. Women will be aware of the controversy surrounding it, but will they know that Barr developed the medication? Will they care? Only time will tell.

at the Lucidicus Project.  Thanks to the host Jared M. Rhoads for including my article on full disclosure and the pharmaceutical industry.

The FDA announced today that it has approved the use of the oral contraceptive Plan B for limited use by women 18 years and older.  According to an FDA press release, Barr has agreed to implement the CARE (Convenient Access, Responsible Education) that will:

- Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

- Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;

- Packaging designed to hold both OTC and prescription Plan B.  Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

- Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Learn More
- Click here to read a Wall Street Journal story about the FDA annoucement.

- Click here to access the FDA Web site focusing on Plan B.

- Click here to read an article recently posted on this blog about the Plan B issue.

A few weeks ago, I sent an invitation to a number of healthcare bloggers asking them to answer two questions about the growing consumer-driven healthcare movement. I’m happy that several of them responded to my request.

In this three-part series, I have been republishing their reponses to my questions.

Part three of this series features commentary from Nedra Weinreich. Weinreich, founder and president of Weinreich Communications, works with nonprofits and government agencies to bring about health and social change using social marketing. She is also author of the blog Spare Change.

Click here to read parts one and two of this series.
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In the most recent edition of Envisioning, my firm’s quarterly newsletter, I focused on what the pharmaceutical industry should communicate to shift negative public opinion of drug companies.  Respondents to an informal poll I conducted said that industry should “communicate its efforts to balance profit and human need.”

It looks like PhRMA, the industry trade group, is trying to do just that.  PhRMA recently released a report, “Value of Medicines” that highlights how new prescription drugs have lengthened life spans, saved money and increased productivity.  I’m sure industry supporters will be using the facts and figures in the report to rebut critics who say that drug companies develop unneeded medications and put profits over people.

Click here to read the report.

[Via Eye On FDA]

Everyone’s buzzing about the failed BMS/Sanofi-Aventis deal with Apotex. Its an interesting and important story, especially in light of the fact that many drugs will be going off-patent in the next few years.

Drug companies have been pursuing a number of different strategies to stave off generic competition. A popular one is signing deals with generic manufacturers to get them to postpone the introduction of a lower-cost pill. Another tactic drug firms use is to lower the price of their “branded generics” to capture a portion of the revenues ordinarily earned by generic manufacturers. According to Market Watch, BMS/Sanofi-Aventis are currently considering this strategy.

Fire The Lawyers?

BMS/Sanofi-Aventis signed deal with Apotex that leaves a lot of observers scratching their heads. According to Pharmaceutical Executive:

“[T]he deal contained detailed concessions to Apotex–including a provision that waived the right of BMS and Sanofi to seek treble damages for patent infringement. These concessions remained in force even after state attorneys general failed to approve the deal, and Apotex went ahead and launched the product ‘at risk.’”

BMS is saying that the Plavix debacle may result in layoffs and decreased R&D. I wonder if the lawyers who inked this deal will be the first to go.

Deals, Discounts and The Coming Wave Of Generics

According to Forbes magazine, “by 2011, a quarter of current drug sales in the U.S. will be eaten away by less expensive generic pills as medicines lose patent protection.”

The coming wave of generics may indicate that more drug firms will be discounting formerly brand name medications. However, it also means that people are looking at the failed Plavix deal very closely. Will deals between pharmaceutical and generics manufacturers go the way of the dodo? Or, will drug firm lawyers find new ways to preserve their revenue streams? Only time will tell.

A few weeks ago, I sent an invitation to a number of healthcare bloggers asking them to answer two questions about the growing consumer-driven healthcare movement. I’m happy that several of them responded to my request.

In this three-part series, I’ll be republishing their reponses to my questions.

Part two of this series features commentary from Dmitriy Kruglyak. Kruglyak is publisher of The Medical Blog Network, a leading community of healthcare blogs.

Click here to read part one of this series.

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In recent weeks, the media has highlighted ties between the pharmaceutical industry and clinical trial investigators. A key focus of these reports has been the fact that a number of authors have not disclosed that they received support from drug firms to conduct and publish the results of clinical trials.

Two of these cases were reported by the Wall Street Journal. One incident focused on the publication of an article in JAMA on the use of antidepressants by pregnant women. The study authors warned that if these women stopped taking medication they would increase their risk of again suffering from depression. However, the authors did not disclose that they had been paid by drug manufacturers. In another instance, a study was published in Neuropsychopharmacology touting the use of a widely-debated treatment for refractory or resistant depression. Again, the authors failed to inform the journal of their financial relationship with pharmaceutical companies.
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The latest edition of Health Wonk Review is up at The Healthcare Blog. Matthew, thanks for highlighting the healthcare blogging survey I’m running with The Medical Blog Network. Please go over, take a look, comment and participate in the next edition.