What does contaminated heparin in our drug supply chain have in common with Memorial Day BBQ?

Scientific Protein Laboratories, the company that brought us contaminated, deadly heparin made from pig intestines was founded by Oscar Mayer, the company that likely will be providing the hot dogs you grill on the barbee this holiday weekend (see the story in the News Times: “Financier Stands by a Firm Tainted by Heparin“).

Mr. Mayer was “apparently interested in profiting from the whole pig, and he started [Scientific Protein Laboratories] to make use of the animal byproducts of his food empire,” says Jacob Goldstein over at the WSJ Health Blog.

I call this the “snout-to-anus” food-drug supply chain, which is best depicted in this illustration:

Scientific Protein Laboratories is owned by American Capital, an investment firm that clearly is interested more in financial gain than it is in the nation’s drug supply. American Capital owns about 170 other companies that make up what I am sure is a diverse portfolio of holdings.

Is any one else disturbed that there are such companies determining which end of the pig we end up with? I think some in Congress might be concerned.

Peter Pitt asks “Where are all the dead bodies?” in a recent post to this blog. “Have you noticed that folks in Washington, DC have stopped asking this question?” says Pitt.

Pitts has misquoted Minnesota Gov. Tim Pawlenty (a Republican) who testified before Congress in support of the re-importation of Rx drugs from Canada. In response to PhRMA’s and FDA’s criticism of re-importation as “unsafe,” Pawlenty said “My first response to that is show me the dead Canadians. Where are the dead Canadians?”

Now that re-importation of FDA-approved drugs from Canada is no longer an issue, Pitts’ focus is on the real danger: adulterated counterfeit drugs. He cited recent revelations about the possible deliberate adulteration of heparin somewhere along the supply chain, possibly in an effort to reap extra profits the same way cocaine dealers do it — by bulking up product with supposedly inactive ingredients. In the heparin case, however, the “inactive ingredient” may have been responsible for causing 81 deaths — and counting!

I say “and counting” because the FDA’s warnings about and recalls of heparin are going unheeded at many hospitals that have stocks of the product. Could it be that protecting “profit” is on their minds as well? Heparin, after all, has been a very good money maker for the health industry — including physicians and hospitals.

On top of all this we now hear that Baxter International has been accused of failing to co-operate with Chinese authorities trying to investigate the alleged heparin contamination. Baxter, in turn, points the finger at the FDA for failing to inspect the Chinese plant at the center of this brouhaha.

It seems no one wants to say “the buck stops here, we are responsible.” IMHO, if the drug industry is going overseas to produce 80% of the ingredients in our drugs, then THEY are ultimately responsible for the supply chain that THEY set up. After all, the FDA didn’t tell them to do it!

According to the World Health Organization, adherence refers to “the extent to which patient behavior corresponds to the recommendations of a Health Professional.” When patients fail to take their medicine as prescribed, the financial impact on the pharmaceutical industry is substantial. Even more distressing is the damage that is done to a patient’s health and well being.

IMS statistics indicate that for every 100 prescriptions, only 50-70% actually make it to the pharmacy to begin with. From there, adherence may be lost at any point, from picking up the first prescription to picking up refills. Only an estimated 15-20% of patients take their medicines correctly, and for as long as they should.

Drug safety concerns are among the many reasons why patients neglect to fill prescriptions or continue taking their medications as prescribed. I know this from personal experience. Recently, my physician recommended that I take Crestor for my high cholesterol. I have heard some troubling things about Crestor’s side effects from people I consider professionals and who should know about these things. Consequently, when I was first prescribed Crestor I did not fill the prescription.

How might I have acted if Crestor marketers focused squarely on the safety concerns of Crestor rather than touting the benefits to better compete with Vytorin (or rather to take advantage of Vytorin’s recent bad publicity)?

An example I like to point to is the ongoing 150-second Celebrex TV ad — and the 2-page print ad (see figure below) — that proclaims “Understand the risks. See the Benefits.” This ad is an example of what has been called a “risk-first” DTC advertising.

Although the Celebrex ad has been criticized for mentioning “death” several times, an article in Pharmaceutical Executive Magazine suggested that this “risk-first DTC” appears to be a new tactic—”to persuade the public about a drug’s usefulness … acknowledging the negative allows the product to gain credibility, mitigates resistance and counterarguing, and permits information that would normally ‘hit a brick wall’ to be viewed in a credible context.”

The idea that being up front about communicating risk to consumers can actually increase credibility in a troubled brand is fascinating. Even more fascinating is the suggestion that better communication of drug risks can achieve greater adherence.

I first heard this idea expressed by Hugo Stephenson, President, iGUARD.org (listen to a Pharma Marketing Talk audio interview with Stephenson) during a panel discussion I hosted last month at the 2nd Annual Pharmaceutical Sales & Marketing Executive Congress, held in Rockville, MD.

“One of the things we are exploring is whether or not better communication about risk can improve compliance,” said Stephenson. “Communicating risk should not be just about avoiding liability, but it could actually give patients a better experience with the product and result in better compliance. For example, if you know certain patients are more at risk to get nausea when taking a drug, you can communicate that risk along with tips on how to avoid the problem. This can reduce side effect dropouts. This can be supplemented by the sharing of patient information, which can help other patients put their risk in perspective.” (See “DTC Risk Communication” in the April 2008 issue of Pharma Marketing News.)

Pfizer began airing it’s “risk-first” Celebrex ads over a year ago and continues to do so today. That must mean that the ads are effective, considering the price of running them on TV. And they may be effective because putting risk first AND in perspective not only helps patients “understand the risks” but also see the benefits of adherence.

As for me, without any upfront discussion about the risks of Crestor from AstraZeneca to comfort me, I am sticking with Pravachol — a tried and true brand I have been taking for years! [Actually, I hope to switch to the generic pravastatin and save some money as well!]

I’m not talking about drug re-importation by little old ladies or Internet drug sites. I am talking about the active ingredients found in prescription drugs.

The Wall Street Journal reported (here; subscription may be required) that “About 80% of active ingredients used in drugs sold in the U.S. come from overseas, a figure that has significantly increased in recent years.” But FDA commissioner Dr. Andrew von Eschenbach had to be repeatedly drubbed by Rep. John Dingell of the House Energy and Commerce Oversight and Investigations Subcommittee before he came up with an estimate for how much money the FDA would need to inspect foreign suppliers to the drug industry.

“You presided over this because you do not have the resources to do the job that you need to do,” said Dingell. “How much money do you need to do the job that you are supposed to do?”

Instead of giving Dingell a straight answer, von Eschenbach replied “Mr. Chairman, I would like to have the resources that would enable us to do a systemic overhaul of the entire process, not a figure that’s related to a cost per inspection times the number of facilities.”

That’s von Eschenbach for you. Systematically ineffectual!

“In November, the Government Accountability Office found that the FDA could inspect about 7% of foreign companies annually and on average inspected such facilities at a rate of once every 13 years. The agency is required to inspect domestic companies every two years and to inspect foreign facilities before the agency approves a new drug or medical device made in that facility. However, there’s no requirement for foreign reinspections.” (WSJ, op. cit.)

The “foreign active ingredient” problem already has been more deadly than any counterfeit drug ordered over the Internet. The recent heparin crisis caused an estimated 81 deaths.

Americans cannot wait for von Eschenbach’s long-promised but never delivered “systemic overhaul.” We need an FDA commissioner that is straight-talking and who asks for and receives the funds needed to do the job!

That’s my opinion. What’s yours?