The problem, it turns out, is that the study was funded by a cigarette company.

In “Cigarette Company Paid for Lung Cancer Study,” published March 26th in the New York Times, Gardiner Harris explored the link between the little-known charity funding Henschke’s research, the Foundation for Lung Cancer: Early Detection, Prevention & Treatment, and the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands.

Hensche denies any implication that she tried to deceive the public, stating that the gift was announced publicly when it was received and that any kind of research on the internet might have revealed its source.  However, Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine, seems to believe that there is some deception involved.  “You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’ ” Dr. Kassirer queried in the article. “They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.”(1)

Hensche does have some lung-cancer advocacy organizations supporting her as a result of her research, and there’s even been an effort to bring legislation to New York, Massachusetts and California that will set up trusts to pay for some of the expenses of the CT scan.  The revelation of her funding source, however, will taint those efforts.

Conflict of interest comes up all the time in pharmaceuticals and biotechnology companies, but the lines drawn between what is right and what is wrong can be faint in many cases.  In this case, however, it seems clear to me that Hensche, even if she didn’t actively “hide” the truth, didn’t actively volunteer the effort.  I know that as a researcher you must be creative in the ways you find your funding, but is sleeping with the enemy worth the risk of tainting your reputation as a researcher?

How do you feel about this?

(1) See “Cigarette Company Paid for Lung Cancer Study,” Gardiner Harris, New York Times Online, March 26th, 2008.

Installing More Flashing Red Lights

In “FDA Turns Attention to Detection,” Jill Wechsler concentrates on upcoming changes to the FDA’s Adverse Event Reporting System (AERS). AERS is the FDA’s current surveillance method for drugs currently available to the public, tracking some 4 million case reports and growing by about 300,000 submissions per year. While the information is extensive, its quality varies and has been identified as a major shortcoming in the current iteration of the system. (1)

Regardless of the quality of data, however, the FDA defends AERS’ use because it covers all FDA-regulated products and subsequently reaches a large portion of patients, including any that might be using a drug for an off-label purpose. It is considered especially effective at highlighting rare, unexpected drug safety problems, a sentiment echoed by a majority of healthcare professionals and cited as a reason that the system should be strengthened and augmented by other safety systems, not replaced.

To Imply or Not To Imply

While the FDA works on safety, Congress is staging an investigation into the celebrity endorsements that are accompanying more and more direct-to-consumer (DTC) ads on TV. In “Attack Mounts on DTC Ads,” Jill Wechsler outlines a new effort by Michigan Democrats John Dingell and Bart Stupack to challenge Pfizer’s use of celebrity spokesman Dr. Robert Jarvik, a prominent contributor to the invention of the artificial heart, in commercials for Lipitor (atorvastatin), the blockbuster anti-cholesterol drug. I recall the commercial vividly, its impact perhaps resting in the subconscious part of my brain, and I remember assuming that Jarvik was giving his testimony based on the background of a heart specialist.(2)

Contrary to my belief, Jarvik is not a heart specialist and it’s probably inappropriate to imply as such; it is because of this misleading advertising to consumers that Dingell and Stupack have chosen to investigate. Also on their list for investigation is Vytorin commercials, a joint venture by Merck and Schering-Plough. The Congressmen have been provided documentation by the FDA, and the investigation is currently ongoing.

Rx Email: Redux

In Europe, the United Kingdom is attempting to halt false advertising from another source: illegitimate online pharmacies. According to “UK Tackles Faux Pharmacies Online” by Sarah Houlton, the Royal Pharmaceutical Society of Great Britain (RPSGB) has launched a new logo that will help certify an online pharmacy is a legitimate source of medication for consumers. You may recall I examined the ever-expanding problem of online pharmacies in “Rx Email,” and indicated that the increasing prevalence of this problem necessitates action by agencies around the world; with an estimated 2 million people now use the internet to buy their medications in the UK, it is becoming obvious that the issue likely needs to be dealt with now.

Registered participants in this program will receive a new logo and registration number to be used on their home page. The logo will be a link leading to a list of legitimate sources for online drugs as maintained by the RPSGB. Almost 50 online pharmacies now participate, and the hope is that the system will discourage the dishonest traders. (3)

The magazine, as usual, gave me plenty of material to think about. Does the FDA AERS need to be augmented? Or should the original system be re-examined and re-built to encourage a more efficient and effective process? Should drug companies be allowed to use celebrity endorsements and imply claims that they cannot make? Or is this type of marketing no different than the marketing of a car (buy our car and you will be cool) or some other product? Where do the differences lie? Could the method being developed by the RPSGB really discourage the sales of illegitimate drugs online, or is it simply another roadblock for these bogus sources to overcome?

Regardless of the answers to these and other questions that may arise in my mind as I continue to read, it appears there is increasing effort by governmental organizations to keep their consumers safe from spurious, possibly false and sometimes illegal dissemination of information. No agency is perfect, but it is encouraging to know there are people within them who are doing their best to make me a little safer as a consumer.

What do you think?

(1) See “FDA Turns Attention to Detection,” Jill Wechsler, Pharmaceutical Executive Magazine, March 2008, p. 14.

(2) See “Attack Mounts on DTC Ads,” Jill Wechsler, Pharmaceutical Executive Magazine, March 2008, p. 18.

(3) See “UK Tackles Faux Pharmacies Online,” Sarah Houlton, Pharmaceutical Executive Magazine, March 2008, p. 18.

Among the companies sure to get a piece of coal in their stocking this year are the online pharmacies from whom you’re sure to get at least one piece of spam in your inbox a week. You know the type: “Get Cialis Cheap! Many other discounts! Save up to 75% off regular store prices!” I normally just delete them and go on my merry way. However, at a recent networking meeting, the presenter was an IT professional and spoke of spam mail, bringing up the pharmaceutical variety specifically. This very blog receives countless comments per week with links to cheap drugs everywhere (which, as the gatekeeper, I subsequently delete). And this month’s Pharmaceutical Executive magazine also targets the phenomenon in one of its articles on Alternative media. The piece, “The $4 Billion Cyber Fraud” by Frederick Felman, delved into the reason these marketing tools have become and continue to be so prolific, and why they could even be dangerous to your health.

Pharmaceutical sales hit $305 billion in the United States and $609 billion worldwide in 2007.(1) The size of that market alone is enough to spur on anyone, and as the title of the article indicates, the online pharmaceutical market has done so to the tune of $4 billion. Its success can be attributed to a solid, if shady, marketing campaign which targets big-name drugs as its hottest selling item, drawing people in by the name brand that posters its bulk email.

If all of these sales were from legitimate online pharmacies, I would applaud their efforts, no matter how distasteful I find their methods…their ultimate goal, after all, is the sale. However, as the article supports through its data, there are several problems with the 3,160 online pharmacies, 59% of which are based in the United States. First, fewer than 10% require prescriptions for what are supposed to be prescription medications. Second, only a measly 4 (that’s not 4%, that’s the number 4) have earned their Verified Internet Pharmacy Practice Site (VIPPS) accreditation.

Perhaps the biggest problem is what the non-certified pharmacies offer: junk. There’s one case described in the article where a 57-year-old Canadian woman died late in 2006 after taking a pill that she bought online. News reports that followed her death indicated that the drugs, originally sold as anti-anxiety medication, tested positive for uranium, strontium, selenium, aluminum, barium and boron. It was from a Canadian supplier claiming to be legitimate. Another company claiming to be Canadian was in fact based in Russia and had faked its accreditation, selling individual pills that were not legally available in a single-pill dose. Some pharmacies online offer junk protection of their customers’ personal data, having no protection on their sites such as a Secure Socket Layer (SSL) or encryption, two common types of security measures.

These problems with online pharmacies put 2 groups at risk. The most obvious is consumers, exposing them to drugs which could be placebos or possibly worse, the constitution of the drugs sold never approved by the FDA. The second group is the pharmaceutical industry, as these online pharmacies ar taking legitimate business away by selling their wares at a fraction of what they should cost. Given the current state of Big Pharma today, I would think it would be in its interest to take a proactive approach at squashing the proliferation of these fraud marketing campaigns. While it would come at some expense to reduce the kinds of drug emails that flood our mailbox every day, it would likely result in increased sales of drugs from a legally responsible supply chain.

The phenomenon is much like that of piracy in the world of technology — illegitimate companies selling “real” products at prices that are too good to be true. Software companies don’t have the kind of revenue Big Pharmas have (well, maybe save for Microsoft and Apple), yet they manage to put together a pretty good campaign to ensure customers understand the dangers of software piracy, how it affects the bottom line and how it could affect them, for example, by a piece of software laden with a computer virus or trojan horse. Big Pharma has a responsibility to itself and to its customers to do the same.

What do you think?

(1) See “The $4 Billion Cyber Fraud“, Pharmaceutical Executive Online, Frederick Felman, December 2007.