Wednesday, May 25, 2011

Sanofi's "Strategic Use" (ie, Bribery) of "Third Parties" (ie, Physicians) to Influence the FDA

In a report titled "Sanofi's Strategic Use of Third Parties to Influence the FDA," the Senate Finance Committee said Sanofi SA "contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval" of the generic version of Levenox, a bloodthinner that had global sales exceeding $4 billion in 2009.

According a WSJ article (see "Sanofi Pays Doctors to Dis Generic Version of Lovenox"), "between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000" to Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division of Duke Medicine (see "Duke medical researcher named in Senate report").

Dr. Tapson and the North American Thrombosis Foundation wrote letters to the FDA that claimed generic versions of the anti-clotting medication may not be as safe as the brand-name drug. Nowhere in these letters did Tapson or the Foundation disclose financial connection to Sanofi.

In an internal email, a Sanofi public-relations representative characterized the Society of Hospital Medicine letter as a "key accomplishment."

"If we were writing the FDA now," said Larry Wellikson, society's director, "we would be very clear about our relationship with any partner, including financial support."

DUH!

Monday, May 23, 2011

Dangerous Chemistry at Home and In Your Face! A Lesson from Pfizer Think Science Now Blog

I just received notice that the following @pfizer_news tweet was recently posted to the "News Direct from Drug Industry" forum of Pharma Marketing Network Forums (see here):
pfizer_news: Dangerous chemistry at home. Read TSN Member Adam Gilbert's blog on Ned trying to unclog a sink/shower drain: http://on.pfizer.com/iKb4dQ
I decided to click on the link, which brought me to "Dangerous Chemistry at Home, Part 3 – Unclogging that Drain" posted on the Pfizer Think Science Now Blog. It's pretty hilarious. It's the latest installment of a series titled “What Will Ned Do Next?” in which the author Adam Gilbert -- a Pfizer chemist -- examines how his neighbor will "potentially hurt himself through his na├»ve understanding of chemistry using common household products."
"The real fun begins when Ned decides to mix these chemicals in an effort to bust up a tough clog quickly.
  1. First he pours Liquid Plmr into his clogged drain: NaOH and sodium hypochlorite (an oxidant)
  2. After a period of time, he pours Runo at the clog: mostly HCl
  3. Finally, he pours in Drano: NaOH, sodium nitrate (NaNO3), sodium chloride (NaCl) and aluminum"
The results had me ROTFLOL!

But within minutes my laughter was over when I received one of those spam e-mails from "Cholesterol " bringing me unsolicited information under the subject line "Unclog your arteries."

Coincidence?

I think not. It may be a coincidence that the Pfizer blog post was about "unclogging" drains and the spam e-mail subject line referred to "unclogging," but -- as I have pointed out before -- it's no coincidence that pharma companies (especially Pfizer) are responsible for these spam e-mails (see "Pfizer is Responsible for 18% of My Spam Email!").

When I click on the "READ MORE" link on the e-mail, I am sent to a Web site that looks like this:



The VERY FIRST link on this screen (High-Cholesterol-Rx-Treatment.com; the administrative contact for this domain is Pfizer Inc. (NYHQ); see WHOIS entry) leads to the LIPITOR drug site. LIPITOR, of course, is a Pfizer drug.

What About Other Instances of "Dangerous Chemistry?"
Although Adam Gilbert's post is about his neighbor "Ned" and dangerous mixing of household chemical products, a similar blog post could easily be written about "Marge" and her dangerous mixing of prescription and over-the-counter drugs! IMHO, Pfizer should blog about that, so that their patients better understand that the chemistry of drugs can be dangerous also! The title of THAT blog post could be "Dangerous Chemistry in Your Face -- Unclogging That Artery."

Saturday, May 21, 2011

FDA, DOJ, & Google: Conspiracy Theory, Part 2

Last week, I suggested that the FDA’s infamous 14 warning letters sent to major pharma companies regarding violative search engine ads may have been a "shot across Googles bow," intended to force Google to halt its acceptance of ads from "illegal" online pharmacies (see "How FDA, in Cahoots with DOJ, Brought Google Down").

Many people did not take my "conspiracy theory" seriously. Some pooh-poohed my suggestion that the FDA was involved. One commenter to my blog said "OMG... what a stretch...I'm sure they are laughing at you at FDA."

It turns out that the FDA WAS INVOLVED in the criminal investigation of Google by the Department of Justice (DOJ).

Today, the Wall Street Journal reports that "as part of the criminal investigation, undercover agents for the Food and Drug Administration contacted Google posing as representatives from rogue Internet pharmacies" (my emphasis; see "Google Was Warned Repeatedly About Illegal Drug Ads").

Even if the FDA was involved, my "conspiracy theory" would not hold water UNLESS the investigation of Google preceded the issuance of FDA's warning letters at the end of March, 2009.

In my previous post, I couldn't cite specific evidence that the investigation went back prior to 2009, but now the WSj article confirms this to be true.

The period 2008-2009 saw a lot of activity related to this investigation, according to documents reviewed by the WSJ. Here are some key actions during that period reported by the WSJ:
"In July 2008, the National Center on Addiction and Substance Abuse at Columbia University (CASA) wrote to Eric Schmidt, then Google's chief executive, saying it found 'prominent displays of ads for rogue Internet pharmacies' in a Google search for controlled drugs."
In December, 2008, the National Association of Boards of Pharmacy, or NABP, a group representing state regulators in the U.S. and Canada, wrote letters to Google "warning about advertising from online drug outlets that weren't verified by a NABP screening program. The organization was 'deeply concerned that these rogue Internet sites could be a front for criminals seeking to introduce adulterated medications, counterfeit drugs, or worse, to the American market,' wrote Mary Dickson, the NABP's associate executive director. The NABP says Google didn't respond."
Google DIDN'T RESPOND?! That suggests it needed convincing. What better way to get google to respond than by sending out 14 warning letters to its BEST clients, effectively shutting down Google's legitimate drug ad revenue? (read more about this in my previous post).
"'On the basis of our analysis, I think they were turning a blind-eye,' said Bryan Liang, a California Western School of Law professor who published a 2009 report that found Google and others were profiting from online ads paid for by illegal drug sellers. 'They were making a lot of money on this.'"
"In 2009, LegitScript LLC, which monitors online drug sellers, published reports alleging that 80% and 90% of Yahoo and Microsoft's respective online drug advertisers were breaking the law."
"John Horton, who runs LegitScript, said his company also conducted in 2009 an unpublished review of Google's ads and found the same level of problems. LegitScript is now employed by Google to help identify problem sites, he said."
"PharmacyChecker [the third-party company that Google hired to verify that online pharmacy advertisers were legal] said it received a subpoena from the FDA in 2009 to produce all its communications with Google regarding pharmacy verification policies."
It is clear that the FDA and DOJ were investigating Google long before the FDA sent those March, 2009, letters.

Some of the reports and activities described above happened AFTER FDA sent the letters  (eg, the LegitScript report was published in August, 2009; see here). No doubt these reports were published due to the light the FDA letters shone on Google's drug ad policies. IMHO, the letters not only impacted Google's revenue, they also elicited further data from third-parties to bolster the DOJ's case against Google.

Friday, May 20, 2011

The End is Nigh! Judgment Day For Low Cost Generic Meds

Some people think "Judgment Day" will come tomorrow, May 21, 2011, at 2 a.m. Eastern Daylight Time at which time will begin the "rapture" where "all the graves will be opened and all of the dead bodies will come out" and only the true believers will be saved.

I don't believe in that particular fantasy, but I do believe the end is near for so-called low cost generic drugs.

Several recent signs suggest that the stars are aligned against low cost generic drugs. Here's my summary of these signs.

For quite some time we've heard about "Big Pharma’s Record Drug Shortages" (see "The nation is facing an unprecedented drug shortage" and "What’s Behind Big Pharma’s Record Drug Shortages?"). Shortages might be caused by "too many mergers and acquisitions" that have reduced the number of suppliers.

Those stories put the blame on "Big Pharma," by which they mean brand name drug manufacturers. However, lost in the copy is the FACT that "almost all the shortages are generic drugs."

The second sign was reported by Jim Edwards over at bnet in his post "4 Pharma CEOs Admit They Jack Up Drug Prices for the Hell of It."

Edwards quotes David Snow, chief executive officer at Medco Health Solutions: “As their branded drugs approach the patent cliff, there has always been the tendency to see increased pricing toward the end, just to get the last dollar out of every drug before they lose brand protection."

Yet an NPR article titled "Big Pharma's Golden Age Leads To Generics Windfall" suggests the "wave" of drugs going generic "can save consumers plenty of dough."

That would be true if generic drug companies as well as brand drug companies were not jacking up prices "for the hell of it." Actually, prices are jacked up because there is a shortage, which can be artificially produced if there is a drug industry consolidation, which there seems to be in both the generic and brand name industries.

I've heard that the price of generics has NEVER been as low as some people believe even in times where there were no shortages. Actually, the prices of some generics can be as much as 80% of the equivalent brand name drug. Why is that? I mean generic drug companies have practically NO marketing budgets, which have been blamed for high brand name drug prices by pharma critics. You'd think that without the marketing and associated overhead expenses, generic drugs would be dirt cheap!

The fact is, "three-quarters of prescriptions these days are filled with a generic," points out NPR. "And the proportion keeps climbing." That means that generic drug companies have almost "cornered the market" (for small molecule drugs) and can charge what that market will bear (in the U.S., that is, where there are no price controls).

And soon the generic drug industry will "corner" the biologic drug market as well.

"Should the market develop according to plan," notes a WSJ article, "copies of these complex drugs [biologics] alone could make up around 50% of the expected $10 billion biosimilars market by 2016, according to data compiled by Capgemini Consulting" (see "Generics Companies Weigh In on Biological Drugs").

As biologics vie for the market to replace small-molecule pills, the situation will even be worse. As a commenter to the NPR article stated "Makers of brand-name biologics are spending big money to delay biosimilars coming onto the market, so even tho biologics like Enbrel, that goes off patent next year -- without the availability of a “biosimilar" – the cost of Enbrel will still be $1,500 a month."

The generics rapture is upon us! Save yourself!

Friday, May 13, 2011

FDA Targets Genetic Testing Services for Advertising Unapproved "Medical Devices"

FDA recently  (May 11, 2011) sent letters to two DNA testing services concerning their Direct to Consumer (DTC) advertising. The companies are Precision Quality DNA (see letter here) and Lumigenix Inc (see letter here).

Precision Quality DNA, offers a service intended to help individuals "understand the analysis of their DNA sequence while focusing on main target genes, such as BRCA1/BRCA2, to determine that individual’s main risk factors or likely response to a particular drug." FDA claims that the service "appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."

Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:
“... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or] intended to affect the structure or any function of the body of man or other animals.”
FDA looked high and low in its files and "ha[s] been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Precision Quality DNA. We request that you provide us with the FDA clearance or approval number for the Precision Quality DNA . If you do not believe that you are required to obtain FDA clearance or approval for the Precision Quality DNA, please provide us with the basis for that determination."

Actually, Precision Quality DNA does NOT believe it requires FDA clearance and says so right on its website on a page titled "Health, Politics and Regulatory Issues" (see here). On that page, Andre Gous, Co-Founder of the company and addressee of FDA's letter, has some interesting things to say about the FDA and its authority to regulate software as a medical device, including:
"Even if you're in favor of government regulation, you're probably wondering how a 1976 FDA law could be applicable to DNA biotech -- an entire field of endeavor that was unknown to the legislature at that time. And, since that law focuses on devices, the FDA is (no surprise) also classifying more and more things, even things as ethereal as software, as a 'device.'
"If the FDA were simply deluded, that would have been bad enough already. However, the FDA didn't stop there. They mailed intimidating letters to the top 5 DNA biotech US companies, and since then they have mailed out 14 more such letters yet."
After that it's pretty much an Ayn Rand style rant; ie, government should just leave capitalists alone.

My guess is that Precision Quality DNA was not among the the "top 5 DNA biotech US companies" that previously received letters from the FDA. To paraphrase it's marketing tag line, Precision Quality DNA "Dodged the Bullet with its Name on it" from the FDA in the past, but now has to deal with that bullet. It will be interesting to see who prevails, the bullet or the target.

How FDA, in Cahoots with DOJ, Brought Google Down

FDA’s Infamous 14 Warning Letters were a Ploy to Force Google into a $500M DOJ Settlement Regarding Illegal Online Pharmacy Ads



“…something is happening here and you don't know what it is, do you, Mr. Jones?”

That’s how I’m feeling today as I try to understand what’s really behind the news about Google’s advertising policies, online pharmacies, and FDA’s 2009 warning letters to major pharmaceutical companies. If my thinking is correct, drug industry search engine ads were “collateral damage” in a war between Google and the FDA.

Yesterday, the Wall Street Journal reported that Google is “close to settling a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws” (see “Google Accepted Ads from Illegal Online Drug Stores”).

Not so coincidentally, a few days ago, Google disclosed that it was setting aside $500 million to potentially resolve a case with the Justice Department (DOJ) that involved "the use of Google advertising by certain advertisers."

“The investigation has examined whether Google knowingly accepted ads from online pharmacies, based in Canada and elsewhere, that violated U.S. laws,” said the WSJ article.

The FDA has long struggled to rein in American’s penchant for buying drugs from online Canadian pharmacies and this investigation of Google by DOJ is likely part of that effort. But, as I surmise below, caught up in the case may have been legitimate major pharmaceutical companies as well.

Consider FDA’s infamous 14 warning letters that the agency mysteriously sent in a single day in March, 2009, to major pharmaceutical companies about Google Rx Adwords, saying the ads were misleading because they didn't include risk information (see “FDA Warns Drug Firms Over Internet Ads”).

Could that have been a “ploy” to bring Google to its knees and cave in regarding online pharmacy ads?

In other words, the FDA’s warning letters may have been a “shot across Google’s bow,” intended to force Google to halt its acceptance of ads from “illegal” online pharmacies. FDA could have been saying, “What’s more important to you? Ads from online pharmacies or ads from major pharmaceutical companies?”

FDA’s actions were a strong incentive because "sponsored link exposures to U.S. Internet users declined more than 50 percent immediately after ... FDA warning letters were issued to pharmaceutical manufacturers," according to a comScore study (see “FDA Letters Caused a Prompt, Precipitous, & Prolonged Drop in Pharma Paid Search Engine Advertising”).

It’s likely that this case goes way back because in September 2010, Google disclosed that it had filed a lawsuit against “advertisers we believe have deliberately broken our rules,” in particular involving “rogue online pharmacies” that “illegally sell drugs on the Web” (see “Google’s $500M Charge Related To Pharma Advertising Probe”).

In June 2010, I reported that Google launched a NEW Rx drug ad format that includes everything FDA requires that a drug company include in its direct-to-consumer advertising: fair balance, and direct links to side effects, precautions, dietary information, etc. (see “Finally, A Google Drug Search Ad Format That Has All FDA Could Want... But Pharma Can't Use It!”). The “ads” are really more like public service announcements. They come from National Institutes of Health (NIH) and compete with paid ads from pharmaceutical companies who cannot use the new format (see “Google's New OneBox Rx ‘Ads’ Steal Clicks from Organic Branded Rx Search Results”).

To compensate for that deficiency, Google also has come up with a new ad format for the industry (see “Is Google the New FDA?”).

All of these actions by Google could be designed to appease FDA and DOJ and regain the drug industry’s ad revenue lost as a result of FDA’s warning letters way back in 2009.

You have many contacts among the regulators
to get you facts when someone attacks your advertising
but nobody has any respect, anyway they already expect
you to all give a check to FDA and other organizations
Ah you've been with the professors and they've all liked your looks
With great lawyers you have discussed clicks and sidewikis
You've been through all of Ayn Rand’s books
You're very well read, it's well known
But something is happening here and you don't know what it is
do you, Mr. Pharma?

Wednesday, May 11, 2011

FDA's BadAd Program Lacks Credible Evidence

FDA's BadAd Program is "BadAss" Lately! What a difference a couple of weeks makes!

On April 25 I posted this: "FDA's Bad Ad Program is 'Phoniest Thing Ever!'," which documented that after one year, the FDA's BadAd program only resulted in one warning letter.

In the last few of days, however, the FDA has issued TWO warning letters that resulted from complaints received via the BadAd program. One (here) was dated 4/28/2011 and sent to Forest Laboratories, Inc. In that letter the FDA cited a sales representative’s statements as false or misleading because they promoted "unapproved uses for Savella, [made] unsubstantiated superiority and mechanism of action claims about the drug, and [minimized] the serious risks associated with Savella."

The other letter, dated 5/5/2011, was sent to Warner Chilcott (US) because of a video that a sales rep posted on YouTube, which was a pretty stupid thing to do. You can read about that on Phamalot.

Why the sudden increase in BadAd-inspired warning letters? Could it be that the FDA's recent webinar was effective in getting physicians to rat out pharma sales reps?

Even if the webinar was successful in generating more complaints, the FDA does not work THAT fast. In fact, the first letter I mentioned resulted from a compliant the FDA received ABOUT 8 MONTHS AGO on September 10, 2010!

Not only that, but the complaint was about ORAL statements made by a Forest sales representative on May 12, 2010, which is nearly a year ago! "On Wednesday, May 12, 2010, at approximately 1:15 p.m., a sales representative from Forest made an unsolicited sales call to a physician at his office," said FDA in the letter. Sounds like charges made by a prosecutor at a criminal trial!

Playing the role of defense lawyer, let me point out problems I have with the timeline.

First, why did the physician wait until September 10, 2010, to submit a complaint about something that happened 4 months previously? Did he/she just learn of the BadAd program in September? If so, then the only evidence the FDA has to support the complaint is the physician's affidavit that the complaint is true. THAT'S HEARSAY EVIDENCE!

Suppose the physician RECORDED the conversation with the rep? If he/she did that, then the motive must have been to make a complaint to the FDA. But why sit on it for 4 months? WE SHOULD INVESTIGATE THIS PHYSICIAN'S MOTIVES. Maybe we can discredit him/her on the stand.

But wait, there's no trial. And there's no credible evidence such as violative detail aids, brochures, etc., which the FDA usually refers to in warning letters regarding sales rep misconduct.

No wonder the FDA is not being very transparent about its BadAd program. We can get some interesting information just by reading the letters. Imagine what we can learn if more details about complaints were released.

Tuesday, May 10, 2011

ACCME's Dirty Little Commercial Funding "Secret"

Having nothing better to do on a Saturday morning, I posted results of my latest analysis of sources of Continuing Medical Education (CME) funding reported by ACCME (Accreditation Council for Continuing Medical Education) in its 2010 annual report (see "Pharma Support for Accredited CME Continues to Decline"). I was tardy in doing this yearly task -- the report was made public last July. Better late than never.

The real reason why I posted my ACCME analysis over the weekend, however, is because I had in my hands a study of physician attitudes about commercial support of continuing medical education that was going to be published on Monday and the data was relevant to the post I made after the study was published (see "Physicians Are Concerned About Pharma Support of CME, But Are Unwilling to Pay Their Own Way!").

In the meantime, Derek Warnick (@CuratioCME), CME Director at Curatio, an ACCME accredited medical education company (MECC), posted a response to my analysis of the ACCME data (see "Response to CME Post on Pharma Marketing Blog"). Derek takes issues with many points I made in my analysis, but the most interesting comment he made was this:
"I’m going to let you in on a little secret (although, if you work for an accredited CME organization, you probably already know this): those numbers used by the ACCME to report Total Commercial Support? Yeah, they’re not as cut-and-dried as you might think. Sure, you can look at them and say, “Hmmm... looks like MECCs are getting a LOT less commercial support.” But here’s the thing: the Total Commercial Support numbers you see only reflect the amount of commercial support given directly to the accredited provider sponsoring the activity [Derek's emphasis].
"So, if there is an activity that is co-sponsored by two accredited organizations, the organization responsible for certifying the activity is the organization that receives the commercial support. They then re-distribute the money to the other organization for their role in the activity. Typically, the organization that directly receives the commercial support reports the entire amount to the ACCME; the other organization doesn’t report anything. This has been my experience. The ACCME does allow the option of each organization individually reporting their split amount of the grant, but that gets pretty confusing if you have a lot of activities and lots of partners. The ACCME is fine with it either way; [Derek's emphasis] they just don’t want the money 'double-reported'."
This raises a couple of interesting question. First, however, let me say that this may not be as big a secret as Derek thinks.

In July, 2008, Pfizer announced that it would no longer directly fund CME courses provided by for-profit, third-party companies (MECCs) although it would keep paying for courses offered by medical schools, teaching hospitals and medical societies. Shortly after that, I hosted a survey (see "What's the Best Way for Pharma to Support CME?") that asked respondents if they thought all pharmaceutical companies should follow Pfizer’s lead. The following chart shows the results:


An anonymous respondent clued me in on the "little secret" Derek referred to in his post:
"Med schools, teaching hospitals, and medical societies frequently use MECCs to create their CME anyway, and unless CME is funded by pooled grants (ie, from multiple pharma companies), the bias will be no less than it is in the MECCs, or not much less."
Derek claims that because of this kind of "subcontracting," MECCs may not be getting as small a piece of the CME funding pie as I estimated from the ACCME numbers. Fair enough. But I note that only a small fraction of MECC respondents to my survey thought it was a good idea for other pharma companies to follow Pfizer's lead. That's understandable, because MECCs would have new academic bosses to deal with who may nickel and dime them. It's much better to get your slice of the pie direct from the baker than to beg a piece of someone else's slice!

I think Derek agrees with my analogy. He said:
"How often does this happen? Well, I can’t really speak for other companies, but my guess is it hapens (sic) a lot more frequently then it did 5 years ago. As already mentioned, the Pfizer’s and OMJ’s of the world no longer provide commercial support to MECCs. That eliminates a pretty big chunk of money that MECCs used to report to the ACCME. The alternative now is to find another accredited partner, such as a medical school or physician society, to co-sponsor the activity. That medical school or physician society is the accredited provider and they receive the commercial support. So in the past, where a MECC would have directly received a $100,000 grant from Pfizer (and reported it all to the ACCME), now a co-sponsor receives the $100,000 grant, reports it all to the ACCME, and then sends $50,000 to the MECC (or whatever the split is) for their role. That’s a $200,000 swing in how the commercial support is reported to the ACCME, when in reality the actual difference is only half that. Again, the ACCME is OK with this."
So, Derek and I agree that MECCs are losing more than just crumbs from the pie, but we differ on exactly how big the pieces really are. The more important issue, however, concerns bias. Is there any less bias in commercially-supported CME if industry funding in channeled through medical schools and medical societies to for-profit MECCs than if the funding went directly to MECCs?

Further reading:

eDetailing Technology Spells Death of Traditional Pharma Salesman & Birth of "Sales Cyborg"

"You can't eat the orange and throw the peel away - a man is not a piece of fruit," says Willy Loman in Act 2 of Death of a Salesman. After reading this article in today's Wall Street Journal, many pharma sales reps may be feeling like tossed peeled fruit.

"Big pharmaceutical companies have found replacements for the army of sales representatives they've laid off in recent years: digital sales tools that seek to sell doctors on drugs without the intrusion of an office visit," says the WSJ.

"Tens of thousands of pharmaceutical sales reps have been eliminated in the U.S., creating a void that drug makers are now increasingly filling with websites, iPad apps and other digital tools to interact with doctors who prescribe their treatments."

Let's refer to "digital sales tools that seek to sell doctors on drugs without the intrusion of an office visit" as "eDetailing."

eDetailing in one form or another seems to be making a comeback since the recession hit the drug industry in 2007 and 2008 (see chart on right). I'm not really sure which is the "chicken" and which is the "egg"; ie, whether an uptick in adoption of eDetailing technology lead to the recent layoff of pharma reps or if reps were laid off because of the economy and subsequently replaced by machines.

Despite the title of this post, reports of the death of pharma "salesmen" may be somewhat exaggerated and not all sales reps can be replaced by machines. According to the WSJ:
"When German drug maker Boehringer Ingelheim GmbH launched the cardiovascular drug Pradaxa in the U.S., it put together a digital-marketing package to target doctors, including organizing webcasts for leading physicians to speak to other physicians about the drug. But the company found that sales calls to doctors' offices were still the most powerful tool for driving new prescriptions, says Wa'el Hashad, vice president of cardiovascular and metabolic marketing. 'No doubt digital marketing does have an impact...I don't believe, however, the shift happens overnight. I think it's a gradual shift,' he says."
In the Pharma Marketing News article "The Changing Role of Pharma Sales Reps," Nancy Lurker, CEO of PDI, Inc., says "reaching physicians requires a new level of sophistication. Live rep calls and dinner meetings and other live venues, however, are not going to go away. But the relative market share in terms of the amount of effort and money that is spent on live interactions is going to shrink and you’re going to see more money being spent in the digital communications space."

Some sales reps will morph into what I call "sales cyborgs" who engage in remote live human conversations with physicians aided by technology. See "Pharma TeleWeb e-Detailing" for more information about that.

Predicting the Impact of Technology on Sales
As of now, pilot programs such as TeleWeb e-Detailing have not been evaluated on how well they drive sales, but on other key indicators of success. Notwithstanding push back by some pharma marketing and sales managers, sales technology will continue to evolve and have greater impact in driving new prescriptions.

Back in 2006, Pharma Marketing News hosted a reader survey to predict future trends in the pharmaceutical marketing mix (see survey summary here).

The survey asked readers for their opinions regarding the impact and risk of several physician marketing channels. They were also asked how they saw the mix shifting in the next few years.

When evaluating impact, I asked respondents to think of reach, credibility, and content richness as important factors -- the greater these attributes, the greater will be the impact. Risk factors, on the other hand, include potential to cause customer dissatisfaction or push back, increased regulation, negative publicity, etc. If marketers should avoid the channel, then risk would be high.

The results of the survey can be plotted in graphical form:


Let's focus on traditional face-to-face promotion (rep) and eDetailing or epromotion.

While face-to-face promotion has a very high impact potential it is also risky and is becoming even more risky, according to survey respondents. [Risky because of increasing physician push back, denying reps access to physicians, and state laws attempting to limit access to physicians by sales reps.]

This is what the downward red arrow is showing. In fact, the tip of the arrow is where this channel may be at today!

eDetailing or ePromotion also has high impact. At the time this survey was run, eDetailing was thought to be as “risky” as face-to-face selling, but now it has the potential at least of being LESS risky and MORE impactful than traditional sales reps.

Additional Reading:

P.S. Forgive my use of the terms "salesman" and "salesmen." Obviously, I am trying to relate this to the play "Death of a Salesman." I am not implying that all pharma sales reps are men. Some reps are actually "cyborgs" with limited sexual attributes and some are machines that have no sex whatsoever!

Monday, May 09, 2011

Physicians Are Concerned About Pharma Support of CME, But Are Unwilling to Pay Their Own Way!

Talk about having your cake and eating it too! Commercial funding of continuing medical education (CME) and the potential for bias appear to concern many physicians, yet only a TINY MINORITY (7%) are willing to pay registration fees to eliminate or offset commercial funding sources, according to a report in the May 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Maybe physicians would like ObamaCME; ie, government subsidy of their education?

No, not quite. But they are willing to give up certain things to reduce costs such as eliminating a printed syllabus. They are not, however, keen to give up the free coffee and snacks!

The authors surveyed attendees at live CME courses delivered by the International AIDS Society–USA (IAS-USA), a nonprofit organization that pools the support it receives from industry so that no one company funds any particular program. In total, 770 attendees (a 57% response rate) completed the 22-item survey, which focused on beliefs about commercial funding and potential for bias, willingness to offset the cost of commercial support, knowledge about the costs of producing CME programs, and demographic information.

Although the study surveyed nurses, nurse practitioners, physician assistants, and persons with Ph.D.s or other academic degrees as well as physicians, I'll just focus on the responses from physicians (N = 378).

Potential for Bias
Although he authors never specifically define what they mean by "bias," I think we all know they are referring to influence over the content of CME courses in such a way as to benefit the commercial supporter.

There are several opportunities for bias to creep into CME, all of which involve money from drug and device companies:
  • Faculty members' research may be supported by grants from companies
  • Faculty members may be paid members of company speaker bureaus
  • Faculty members may be paid directly to speak at CME programs
  • The CME program itself is supported to some degree by a grant from a single or multiple companies
Of course, some CME programs are not funded in any way by the drug industry and is paid for entirely  from registration fees paid by physicians (the Institute of Medicine estimates that physicians, on average, spent slightly more than $1400 per year for CME in 2007).

The survey asked physicians how they would rate the bias of CME programs under each of these scenarios. The results are presented in the chart below:


This chart shows the percentage of physician respondents who believe the listed CME funding options have a moderate or large potential for bias.

According to the respondents to this survey, the least potential for bias in CME is when the faculty is completely independent; ie, receives NO funding of any sort from the drug/device industry. However, that is an unlikely scenario given the fact that perhaps 80% of the CME faculty pool receives some form of funding from pharma/medical device companies.

"Speakers will continue to have relationships with industry in various ways, especially for research funding," noted authors of a commentary that was published in the same journal as the report. "Bias will always need to be addressed through speaker disclosures and direct monitoring for bias at CME events."

Given that so many physicians feel that pharma support of CME introduces bias, you would think they would want to eliminate that support. Actually, only 17% of physicians surveyed agreed strongly or somewhat that commercial support of CME should be eliminated entirely (see chart below) and 56% agree that "Pharmaceutical/medical device company support is essential for accredited CME and should not be eliminated" (data not included in following chart).


Physicians were asked what they would be willing to do to "eliminate the need for pharmaceutical/medical device company support" of CME activities they attended. The choices are shown in the list in the above chart.

Only 50% of physicians would give up free food or snacks to eliminate the need for commercial support of CME. BTW, these costs are substantial. Hotels -- where most live CME programs are held -- charge as much as $8.47 for a cup of coffee! "A $9 cup of coffee may not seem to be the most economical use of CME dollars," noted the authors of the study.

It's the Internet Age, Stupid!
Reducing the cost of CME seems to be the best way to eliminate the need for commercial support.

"Barring a substantial reduction in the cost of delivering CME, however, a rapid reduction or elimination of funding might be unacceptably disruptive, and some have postulated that such a change will result in the disappearance of live CME as we know it..." said the authors.

What better way to reduce costs than by delivering CME via the Internet? The survey did NOT ask if physicians would participate ONLY in online CME programs if that meant eliminating the need for commercial support. In fact, more and more physicians are receiving CME credit online (see "Pharma Support for Accredited CME Continues to Decline").

Yes, delivering CME via the Internet would "result in the disappearance of live CME as we know it," but that's a good thing, not a bad thing, given the exobitant costs and biases in the CME as we now know it, IMHO.


SURVEY: Potential for Bias in Commercially Supported CME
Summary of Survey Results

Saturday, May 07, 2011

Pharma Support for Accredited CME Continues to Decline

Pharmaceutical industry support - ie,  direct sponsorship PLUS advertising - of physician continuing medical education (CME) declined 13.3% in 2009 compared to 2008. This is based on income data (see here) provided by the Accreditation Council for Continuing Medical Education (ACCME). This marks the second consecutive year of decline as shown in the following chart:


The following chart illustrates the trend in both types of CME income (direct commercial support AND advertising income) that CME providers receive from pharmaceutical companies:


The pharma industry supports CME by funding different types of ACCME-accredited CME providers. These include for-profit Medical Education Communications Companies (MECCs), medical schools, and physician societies. The following chart shows how this funding has changed over the years:


Physician societies and medical schools continue to take pharma CME money away from MECCs as shown in this graph:


Online CME Trends
Meanwhile, the percentage of physicians who receive CME credit online continues to increase, albeit at a slower rate -- at least for the time being -- as shown in the following chart:


The above chart includes physicians who participating in "Enduring" online CME activities, which ACCME defines as: an Internet that is "available when the physician participant chooses to complete it. It is 'enduring,' meaning that there is not just one time on one day to participate in it. Rather, the participant determines when he/she participates. (Examples: online interactive educational module, recorded presentation, podcast)"

The chart does NOT include physicians who participate in "Live" Internet CME; ie, "an online course available at a certain time on a certain date and is only available in real-time, just as if it were a course held in an auditorium. Once the event has taken place, learners may no longer participate in that activity. (Example: webcast)"

In 2009, only about 38,000 physicians participated in live Internet CME courses compared to 4.5 million physicians participating in enduring online CME.

NOTE: These numbers refer to the number of registered attendees of CME events. Some physicians may attend more than one course and thereby be counted more than once.

Internet Searching and Learning
A third type of Online CME defined by ACCME is "Internet Searching and Learning," in which about 116,000 physicians participated in 2009. This is a CME activity "in which a learner accesses the content of the activity directly from the internet. This is differentiated from a 'course' and an 'enduring material' because the provider does not create the content but rather the learner chooses content based on what (s)he feels meets their needs or answers their questions."

Wow! Physicians can get CME credits just by searching for medical information on the Internet. No wonder Wikipedia has become an important source of information for physicians!

For-profit MECCs were responsible for 99.5% of physicians (115,324) who received "Internet Searching and Learning" CME credits.

I suppose MECCs draw up a list of multiple-choice questions that physicians must answer after searching the Internet. Perhaps they are directed to search certain sites such as WebMD or Wikipedia. It's likely that nobody reviews this information to determine if it is "unbiased." It's possible, therefore, for pharma companies to publish non-peer-reviewed content on these sites and thereby "game" the process and not be held responsible for sponsoring "biased" CME content.

P.S. The 2010 ACCME annual report will be available sometime this July at which time I will update these charts.

Friday, May 06, 2011

Pharma Tracks Docs at Medical Meetings Using RFID Technology

Although the pharmaceutical industry is dragging its feet implementing RFID (Radio Frequency Identification) technology to keep track of drug supplies, some companies are currently using the technology to track physicians' movements at scientific conferences.

"Dr. Wes" (Westby G. Fisher, MD, FACC) called this "Physician Tag and Release" (see "The Implications of Physician Tag and Release"). The photo on the left shows the back of Dr. Wes's badge at the recent American College of Cardiology Conference held 2-5 April 2011 in New Orleans, LA.

The technology is also being used at the Heart Rhythm Society conference going on right now. Propublica and USA Today co-published a story about how doctors are being bombarded with pitches for drugs and medical devices at this conference (see "Financial Ties Bind Medical Societies To Drug and Device Makers").

RFID tracking is a disturbing aspect of industry-sponsorship because it may give exhibitors access to the identity of any physician who enters (or merely passes by?) sponsor booths at medical meetings even if the docs do not talk to reps or give their permission to collect such information.

"Many physicians were unaware that exhibitors had paid to receive real-time data about who visited their booths, including names, job titles and how much time they spent," says Propublica.


The Heart Rhythm Society claims that exhibitors are not getting doctors’ personal information, but here's what the American College of Cardiology says about how its exhibitors benefit from RFID technology (see "Using Technology to Better Understand ACC Meeting Attendees"):
"The second way in which RFID technology is utilized is in the Exposition. Exhibitors were able to rent RFID readers from the vendor. They are able to use the data in much the same way as the ACC – to evaluate how effectively their work stations are structured and to improve their offerings to attendees. In addition, they are given access to limited information about the visitors to their booths. The information they are given is the same information that was available on meeting attendees badges in print (name/city/state/institution). No contact information is provided. ACC’s intention was not to create a revenue source by offering attendee data to exhibitors (in fact, only five out of more than 300 exhibiting companies decided to invest in RFID in their booths), but rather to provide exhibitors another resource by which to understand the traffic flow in their booths and to better align their displays with attendees’ needs."
Instead of "opting in" for tracking at scientific meetings, doctors must "opt out" from the use of tracking technology when registering for scientific meetings.

The practice "disturbs" Dr. Wes who says:
"It is no secret that these societies make a significant portion of their operating revenues from industry sponsors at these meetings. By instituting tracking, the value of their membership's privacy has taken a back seat to the income generated from tracking revenues."
and
"At the risk of sounding like a conspiracy theorist, it is not too hard to imagine one's credentials being called into question in court because a doctor did not demonstrate enough time in CME activities at the scientific sessions to quality for credit or because these data implicate a doctor in a purchasing agreement between a vendor and hospital system simply because a doctor visited a display booth."
Dr. Wes also imagines a scenario where RFID data collected at medical meetings can be combined with a doctor's prescribing information without their permission. That's a double whammy for physicians who wish to keep their prescribing habits private. The Supreme Court is deliberating that issue (see "Supreme Court to Decide Fate of State Laws that Prohibit Use of Rx Records by Pharma").

Wednesday, May 04, 2011

Social Media Clinical Research: Transformative or "A Taste of Armageddon"?

This tweet from my friend @Frank_Antwerpes, CEO at DocCheck (a German online physician community), appeared in my Twitter stream today:
Clinical Research goes social Web: http://bit.ly/kNCHop
If you follow the link, you will find this published study: "Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm". Here's the abstract:
Patients with serious diseases may experiment with drugs that have not received regulatory approval. Online patient communities structured around quantitative outcome data have the potential to provide an observational environment to monitor such drug usage and its consequences. Here we describe an analysis of data reported on the website PatientsLikeMe by patients with amyotrophic lateral sclerosis (ALS) who experimented with lithium carbonate treatment. To reduce potential bias owing to lack of randomization, we developed an algorithm to match 149 treated patients to multiple controls (447 total) based on the progression of their disease course. At 12 months after treatment, we found no effect of lithium on disease progression. Although observational studies using unblinded data are not a substitute for double-blind randomized control trials, this study reached the same conclusion as subsequent randomized trials, suggesting that data reported by patients over the internet may be useful for accelerating clinical discovery and evaluating the effectiveness of drugs already in use.
Pretty interesting, but also frightening.

This InformationWeek story presented the five advantages outlined by the authors of the study:
  1. Speed. It took only nine months from initiation of the tool (March 2008) to the first public sharing of preliminary results (December 2008).
  2. Patient access. There is a potential to rapidly recruit widely dispersed patients with rare conditions and to overcome selection bias favoring patients living near specialist centers.
  3. Availability of control participants. Clinical outcome data were passively collected from thousands of patients who served as potential matched controls.
  4. Cost. Online studies have lower marginal costs per patient as compared with thousands of dollars per patient in traditional trials.
  5. Patient engagement. Patients who submitted data using the PatientsLikeMe website were connected with other patients, which may have a range of benefits.
InformationWeek did NOT list the inherent LIMITATIONS mentioned by the authors. The most important limitation cited by the authors: "Unlike randomized trials, which match the comparison groups on all possible confounding factors, subject only to chance variation, observational studies cannot control for unmeasured covariates."

In the PatientsLikeMe press release, PatientsLikeMe Co-Founder Jamie Heywood stated:
"The rising costs of healthcare and increasing complexity of managing disease require new approaches to comparative effectiveness research and real time management of disease. While there is much work to do, we have demonstrated a patient-centric approach that provides dramatic cost and time advantages."
In these days of budget cuts and R&D cutbacks, pharmaceutical companies may jump on the "Social Media Clinical Research" bandwagon. Some day -- probably not in my lifetime -- FDA may even accept results of such studies as part of the drug approval process. Drug companies, for example, may lobby the FDA to accept such studies as fulfilling post-marketing surveillance requirements imposed on them.

Thinking about the possibilities reminded me of a classic Star Trek episode titled "A Taste of Armageddon."

In that episode, the starship USS Enterprise, under the command of Captain James T. Kirk, sends a landing party to Vendikar, a city on the planet Eminiar VII. Kirk is informed that a fusion bomb just struck the city and killed half a million people. Curiously, everything in the city seems intact and there is no visible evidence or sensor readings of such an attack ever occurring. The landing party soon discovers that the entire war between the two planets is completely simulated by computers which launch wargame attacks and counterattacks, then calculate damage and select the dead. When a citizen is reported as "killed", they must submit themselves for termination by stepping inside a disintegration booth.

The advantages of computer-simulated war are similar to the advantages PatientsLikeMe noted for its Social Media Clinical Research. I imagine the most important advantage of such a computer-simulated war is COST savings! Speed also would be an advantage -- wars can be fought over a period of months rather than years. Access to and engagement of citizens seems to have been solved by the denizens of Eminiar VII. Controls are NOT necessary in warfare.

When researchers land on social communities such as PatientsLikeMe, they may also encounter anomalies such as reports of cures, side effects, trial results, etc. that conflict with "visible evidence or sensor readings," ie, scientific reality.

To which I say:

SOCIAL MEDIA, THE FINAL FRONTIER! ...of clinical research.

Monday, May 02, 2011

GSK, National Headache Foundation and "Migraine Diary." Is There an App for That?

Last week I came across this tweet posted by @GSKUS:
RT @NHF: Need help remembering your #migraines details? Find an online migraine diary from @GSKUS at http://bit.ly/hBS98Q
For my Twitter-challenged readers, I should point out that "RT" signifies that @GSKUS "retweeeted" a tweet originally made by @NHF, which is the Twitter account of the National Headache Foundation.

Whenever a pharma company retweets a message from a third party, it raises some flags. For example, suppose NHF was a patient advocacy organization that promoted off-label use of medications and suppose those medications were marketed by GSK? Further, what if GSK helps support NHF with funding? What if NHF received the majority of its funds from GSK? What if NHF was actually created by GSK and not independent at all?

I am asking these questions because I have previously cited the close relationship between GSK and a supposedly independent Restless Leg Syndrome patient advocacy organization (see Pharma Dollars (Pounds, Euros) are Grassroots Seeds).

These days there are quite a few tools I can use to answer my questions. But, first, let's look at the link in the tweet.

When you click on the http://bit.ly/hBS98Q link in the GSKUS tweet, you discover that the real link is http://www.lowerthepain.com/pdf/Migraine_Diary.pdf. The "Lower The Pain" website (www.lowerthepain.com) is a GSK site that prominently promotes a migraine survey. "Editorial and other support for the survey provided by National Headache Foundation with funding, development, and other support provided by GlaxoSmithKline," says GSK on the site. See this Fact Sheet on the NHF site for more about the survey.


But I also see an invitation to get "tips & tools you need that may enhance your conversation with your doctor today." Right NEXT to that is a picture of an iPhone, which GSK is careful to point out is a registered trademark of Apple Inc.

When I click on "Tools to Help" I am brought to the following screen:


This further HINTS that there is an app for that (ie, "MIGRAINE DIARY").

So, is there an iPhone version of the Migraine Diary?

Yes, there IS an iPhone "Migraine Diary," BUT it does NOT appear to be a GSK app or an NHF app. Here's the app by that name that I found on iTunes:


This is a nice little app, but it does NOT resemble the GSK's PDF version of "Migraine Diary."

The iPhone app was developed by Net Workz LLC, a Software Engineering Firm located in the UK, which is the only connection I can see between it and GSK. In fact, the creator of the app is Aaron Douglas. His about page states that "Net Workz LLC is a small company I started that I use for anything I do geeky-related. I don’t have much content here but I plan on expanding this site soon. My full time job employs me as a software engineer. This place is for my personal projects that need to be legit, like iPhone Apps."

Maybe GSK and Douglas are negotiating a deal right now to allow "Migraine Diary" to "go legit."

The only comment Douglas has received about his app is this:
"I like this app. It's not the fanciest, but I wanted something easy to fill out when I'm in pain! The only problem I have is that sometimes when I add a journal entry, it only shows up when I turn it off then on again, but it is there. I wish it had more graphs to see more than one month, to see a patten. An option for an "all day" headache instead of having to put in a time would be good!"
OK, so what about the relationship between GSK and NHF? There's obviously the survey mentioned above. There's a guest post to GSK's blog by Merle L. Diamond, MD entitled "Teaming up to Close the Gap in Doctor-Patient Migraine Communication" (see here). "Dr. Merle L. Diamond was compensated by GlaxoSmithKline for her participation in this campaign," GSK disclosed. Dr. Diamond is a member of the NHF board of directors.

Dr. Diamond is daughter to Seymour Diamond M.D., Executive Chairman of NHF, who originally founded the National Migraine Foundation, which was renamed the National Headache Foundation in 1987.

Seymour Diamond is the also the founder of Diamond Headache Clinic and Merle Diamond is it's president.

I'm not going to track this much further, but it would be interesting to know how many other physicians involved with NHF and the Diamond Headache Clinic are on GSK's payroll. Now that GSK has been required to list all payments to physicians, it should be easy to find out.

OK, I will track this a bit further. I just downloaded NHF's 2009 IRS Form 990, which has some interesting tidbits an accountant may be able to dechiper.

I notice, for example, that NHF made a "gift" of $1,112,748 to the Seymour Diamond Fellowship Fund [of] the Diamond Headache Clinic Research and Education Foundation. Are the Diamonds using the NHF as their personal piggy bank?

Also, NHF paid $814,955 to Vedanta Associates Inc., an independent contractor, for "research on various projects and programs." Seems like a lot of money for "research." What I've been able to find out about Vedanta Associates is it "provides marketing research and medical communications solutions to the pharmaceutical and heathcare industry."