Sunday, February 27, 2005

FDA Advisory Panels: Elephants in the Room

The New York Times recently reported that "Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers..." (10 Voters on Panel Backing Pain Pills Had Industry Ties, NYT, 2/25/2005).

If these 10 panelists were taken out of the voting, which would be expected if FDA policies on conflict of interest were adhered to (they weren't -- more on that below), then the committee would have voted to take both Bextra and Vioxx off the market (12 to 8 against Bextra and 14 to 8 against Vioxx).

Ninety-three percent (93%) of the time these 10 panelists voted in favor of the drugs, whereas the 22 other panelists favored the drugs in their votes only 56% of the time.
"Of the 30 votes cast by the 10 panel members on whether Celebrex, Bextra and Vioxx should continue to be marketed, 28 favored the drugs. Among the 66 votes cast by the remaining 22 members of the panel, just 37 favored the drugs." -- NYT
It should be noted that the voting preferences of these 10 panelists did not influence the decision to keep Celebrex, marketed by Pfizer, on the market. That is, the vote would have been in favor of Celebrex even if these panelists were excluded from voting.

Financial ties to industry of FDA advisory committee members is not a new issue. A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through June 30, 2000 found:
  • At 92% of the meetings, at least one member had a financial conflict of interest.

  • At 55% of meetings, half or more of the FDA advisers had conflicts of interest.

  • Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts.

  • At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.

Elephants in the Room
If you have ever attended one of these Advisory Committee meetings, you would find that the majority of attendees are representatives of drug companies with perhaps a smattering of public interest groups and a large contingent of press people.

So you can expect that every vote by each panelist is noted and reported back to drug companies with an interest in the matter. This has got to put a lot of pressure on the panel members, many of whom have accepted money from the industry in the past or perhaps would like to accept money from them in the future!

This goes with the territory of open, public meetings. It certainly would not be in the public interest to have secret ballots. So there's not much we can do about that.

But, can't the FDA find panelists without any ties to the pharmaceutical industry? Apparently not. A Washington lawyer "who was until last year the agency's general counsel, said that finding knowledgeable experts without financial conflicts was difficult." (NYT)

The reason is that the industry creates these "knowledgeable experts," which has as much to say about physician education in this country as it does about pharma industry influence over physicians. In short, physicians absolutely depend upon the industry to learn about new products and even the conditions they treat. At least a couple of the "gang of 10" advisors stated as much:
Dr. Steven Abramson, a rheumatologist at New York University School of Medicine who was on the panel, has consulted for Pfizer and Novartis. "The F.D.A. is looking for people who understand the science behind these medicines," and such an understanding often results from working with drug makers, he said.

Dr. John Farrar, a neurologist at the University of Pennsylvania who has received research support from Pfizer and is a panel member, agreed. "I think F.D.A. would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company," he said.
Pharma companies "educate" physicians directly and indirectly in many ways:
  • Sales Representatives -- these "detail" men (and women) are supposed to provide physicians with much needed details about products, but more often than not sales reps are merely there for the hard sell and to drop off samples (see, for example,"A Crisis in Professional Detailing")

  • Support of Continuing Medical Education -- pharma companies often support accredited continuing medical education for physicians, which means that physicians need not spend their own money to obtain CME credits that are required to maintain their licenses to practice medicine. There is some debate on how unbiased industry-supported CME is and there have been abuses (e.g., paying for junkets for physicians to attend "educational" activities at resorts along with their spouses). See, for example,"Provider/Pharmaceutical Partnerships - Are They Possible Without Conflict of Interest?" and "When Is Commercial Support Appropriate for CME Activities?"

  • Key Opinion Leaders -- Key Opinion Leaders are physicians who influence their peers' medical practice, including but not limited to prescribing behavior. Pharmaceutical companies generally engage key opinion leaders early in the drug development process to provide advocacy activity and key marketing feedback. See "Developing Win-Win Key Opinion Leader Relationships" for insights on how pharma companies leverage key opinion leaders. It is probably from this pool of physicians that most FDA advisory boards solicit members.
Anyway, physicians are beholding to the industry for much of their education, a point that was well-documented by Marcia Angell in her book "The Truth About Drug Companies. How They Deceive Us and What to Do About It" (see "The Truth About the Drug Companies: What To Do About It" for a review). As long as that is the case, it will be impossible to find a group of experts without some past ties to the pharmaceutical industry to serve on advisory committees.

Is this necessarily bad? I mean, can advisory committees still make credible decisions given these conflicts?

The FDA, in 2003, did a study of "public attitudes and opinions" regarding conflicts of interest and FDA advisory committee meetings (see "Conflicts of Interest and FDA Advisory Committee Meetings"). They surveyed a sampling of people who attended FDA advisory committee meetings in the spring of 2003 and advisory committee members who participated in those meetings. The study's intent was to examine the perceived fairness and credibility of FDA advisory committee meetings related to FDA's management of real or potential conflicts of interest among advisory committee members.

An overwhelming majority of respondents (67%) disagreed with the statement "When committee members have conflicts of interest, they will always decide in favor of their interest." Maybe they don't "always" do so, but the COX-2 gang of 10 did so 93% of the time (see above). Eighty-seven percent of respondents disagreed with the statement "You cannot trust an advisory committee's decision if any of its members have conflicts of interest." What about if 10 out of 32 have conflicts?

This study was really a survey of the "elephants" in the room -- i.e., representatives of pharma companies. 82% of respondents were "paid by an employer or organization to attend the meeting." Guess what organizations pay employees to attend such meetings?

FDA "Openness" Is At Issue Here
The law requires that FDA advisory committee members disclose financial interests in the subject of the meeting. Financial interest is defined in FDA regulations "as the potential for gain or loss as a result of government action on a particular matter."

But the FDA chose not to reveal the financial ties to the pharma industry of the COX-2 committee members. As reported in the NYT:
Before each of three meetings of the advisory board last week, an agency secretary read a statement absolving panel members of conflicts of interest because the committee's agenda involved "issues of broad applicability and there are no products being approved."

The secretary also said, "The Food and Drug Administration acknowledges that there may be potential conflicts of interest, but because of the general nature of the discussions before the committee, these potential conflicts are mitigated."
On February 15, HHS Secretary Leavitt said "The public has spoken and they want more oversight and openness" (see "Reforms Will Improve Oversight and Openness at FDA" FDA Press Release)
. Unfortunately, during the COX-2 meetings the FDA chose not to take this path, chose to ignore the public and was far from "open" and transparent.

Friday, February 25, 2005

Febraury Issue of Pharma Marketing News Is Here

Pharma Marketing News
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CURRENT ISSUE: Vol. 4, No. 2: February 2005

Links to summaries of individual articles below.

This Month's Survey
  • Pharma Cost Cutting
    Is the "arms race" over? Is it time to cut back on sales and marketing spending? How deep will cuts be? Will cuts be industry wide?

    What do you think? Click here to take this survey. You will be able to see a summary of the de-identified results immediately after completing the survey.

Friday, February 18, 2005

Vioxx Redux

Just when you thought it was safe to go back into the water, Merck suggests that it may put Vioxx back on the market, according to an article in today's Wall Street Journal ("Merck May Return Vioxx to Market").

A reversal of the Vioxx withdrawal would be "a shocking turn of events." So, why is Merck considering doing it?

The article lists several reasons, but none really have to do with serving the interests of their customers (patients and physicians). It's really a matter of "strategy": Merck could benefit in its court battles by arguing that Vioxx is a benefit to some patients; the additional revenue could help boost its finances (e.g., pay for court awarded damages); it would also help its case in getting a similar drug, Arcoxia, approved for sale in the U.S.

As more and more evidence piles up that all cox-2 inhibitors, including Vioxx and Celebrex, may cause increased cardiovascular events, isn't an odd time to suggest the return of Vioxx? Apparently not. That's just the risk side of the issue. You have to look at the benefit side.

"If the advisory committee and the FDA conclude that the benefits of this class outweigh the risks in some patient populations," said Merck research head Peter S. Kim, "then we would have to consider the implications of these new data given the unique benefits Vioxx offers."

In other words, if Celebrex is allowed to stay on the market -- because its benefits outweigh the risks to some patients -- then Vioxx should be allowed to come back. OK, I'll buy that argument. It's a valid point from Merck's perspective.

If Vioxx does come back on the market, Merck should consider renaming it Reduxx.

But does returning Vioxx -- or whatever it's called -- to market make sense from a patient perspective?

Mothra AND Godzilla?
It's like the citizens of Tokyo dealing with Godzilla and Mothra in their midst. Many citizens always argued that one monster was enough, why do we need two of them? They began focusing on Mothra and listing all her bad traits that were harmful to citizens. Mothra, always seeing herself as the friend and savior of Tokyo, decided to leave town and vowed never to return for the good of the citizens. She also felt a bit guilty, recalling many instances in which she inadvertently crushed a few citizens with her wings while fighting Godzilla. .

Meanwhile, Godzilla absolutely refused to leave town. He was powerful and he claimed that there was not enough evidence that his bad traits harmed anyone. At least no one wanted to be first and come forward with accusations.

Eventually, however, the citizens of Tokyo accumulated enough evidence that all monsters, including Godzilla, were bad for some people - especially those that invited them to dinner or hung around with them long enough. Realizing her opportunity, Mothra argued that given this new evidence, she should be allowed back in town if Godzilla was allowed to stay. Is it in the best interest of the citizens of Tokyo to allow Mothra to return?

Tune in next week.

Meanwhile, how are painkillers remaining on the market doing? The following chart, from my friends at ImpactRx, shows the share of New Treatment Starts (NWRx + New Sample Only), which includes prescriptions and sample only for newly diagnosed patients and previously diagnosed patients with a change in medication.

The period covers from the end of October, 2004 to the first week in February, 2005. Note that Celebrex and Bextra have a very low share of NRx. Of course, Vioxx is not shown because it is off the market during this period.

It appears that doctors are voting with their prescription pads and prescribing non-Cox-2 painkillers like Mobic, ibuprofen, and naprozen. Note in particular the success of Mobic because its glory days may be over.

As reported in today's Washington Post ("Vioxx Alternative Potentially as Risky, Official Says"):

"David J. Graham, a veteran Food and Drug Administration safety officer and recent whistle-blower, told a conference reviewing the risks of arthritis painkillers yesterday that Mobic, the medication that hundreds of thousands turned to after Vioxx and other COX-2 inhibitors came under a cloud, is potentially just as dangerous.

"Graham said a large new study he and a colleague had just completed, which FDA officials initially did not want him to present because it was preliminary, indicates that the anti-inflammatory drug is a 'bad actor.' His agency, he added, needs to 'weed the garden of bad actors.' "

Or, as the good citizens of Tokyo might say, All Monsters Must Die!

Monday, February 14, 2005

Drug Safety: A Matter of Trust!

Those Canadians are at it again! Quick they are at being contrary to the U.S. This even extends to drug safety issues.

As reported in the WSJ on 9 February 2005, the U.S. and Canada differ on whether or not the attention-deficit drug ADDERALL is safe ("Why U.S., Canada Differ on Safety Of Attention-Deficit Drug").

Health Canada -- the equivalent to the FDA in Canada -- instructed Shire BioChem Inc., the manufacturer of ADDERALL XR to withdraw the drug from the Canadian market (see "Health Canada suspends the market authorization of ADDERALL XR , a drug prescribed for Attention Deficit Hyperactivity Disorder (ADHD) in children").

The FDA has not followed suite in the U.S. In an advisory it said: "FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada's analyses of adverse event reports and FDA's own knowledge and assessment of the reports received by the agency."

These days, anything the FDA has to say about drug safety -- especially if it is contrary to what its Canadian and UK regulatory counterparts have to say -- may understandably be taken with a grain of salt. Critics of the FDA have questioned not only its ability to fairly evaluate drug safety issues but also its criteria for safety:

"[FDA believes] a drug is safe until you can show with 95% or greater certainty that it is not safe," said FDA whistleblower David Graham before a Senate committee. "This is an incredibly high, almost insurmountable barrier to overcome. It's the equivalent of "beyond a shadow of a doubt." And here's an added kicker. In order to demonstrate a safety problem with 95% certainty, extremely large studies are often needed. And guess what. Those large studies can't be done." (see the upcoming February Issue of Pharma Marketing News).

It appears that Canada and the US (and the UK and the US, maybe even the whole world outside the US and the US) have different paradigms by which they view drug safety. Maybe Canada and the rest of the world outside the US are too quick to pull drugs from the market without adequate scientific evidence?

But, what is "adequate scientific evidence"?

If two renowned organizations with access to the same data and with staffs of medical experts can't agree on when a drug is safe or not, how can an ordinary, non-scientifically-trained patient do so? Even some physicians are confused: "From the doctor's point of view, I find it very confusing and worrisome when two different agencies using the same databases reach very different conclusions," said Murali Doraiswamy, psychiatrist at Duke University Medical Center (WSJ article).

Some FDA regulators are also confused - "We found [the reported cases of death] difficult to interpret and ambiguous," said Dr. Temple, director of the office of medical policy in the FDA's drug center. Is this a case of the FDA's 95% certainty "rule" or honest scientific appraisal of benefit vs. risk?

I wouldn't attempt to answer that question. My only point is that as long as the FDA's ability to fairly judge drug risk is under a cloud of suspicion for reasons that I point out in the article "Does the FDA Need to be Overhauled?" in the upcoming February Issue of Pharma Marketing News, then we -- and I include physicians as part of "we" -- have no way of knowing who to trust.

To improve public trust, the FDA needs to be overhauled so that its drug safety function is separated from its drug approval function. In his Senate critique of the FDA, Dr. Graham said: "The same group that approved the drug is also responsible for taking regulatory action against it post-marketing. This is an inherent conflict of interest."

A large majority (84%) of respondents to a Pharma Marketing News survey agreed or strongly agreed that the job of monitoring safety approval should be separated from that of approving drugs.

The FDA, on February 15, announced a new independent Drug Safety Oversight Board to oversee the management of drug safety issues (see "FDA Improvements in Drug Safety Monitoring"). The plan, however, has already come under attack. The board will have no powers other than to advise the FDA and publish findings on a public web site (the rules for doing so have not been revealed). The board is also internal and will be comprised of FDA staffers and other government employees.

As reported in WSJ Online ("FDA Offers Placebo"):

Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, suggested that the new board would be toothless without greater independence, funding and authority. He added that it should be peopled with full-time staff, rather than pulling government employees from other jobs. "This is a full-time job," he said. Independent monitors "should be the cop on the beat -- not somebody called in once a month to ruminate on the question of whether there's crime."

Also, there needs to be a better program for drug safety surveillance AFTER a drug is put on the market. As the author of the cited WSJ article stated: "The disagreement between the two national health regulators .... is an extreme example of the problems of limited data available on the safety of marketed medicines."

"There's no right or wrong because there's no science." -- Brian Strom, a professor at the University of Pennsylvania.

Left without adequate science to make decisions, the public and medical community can only put their trust in their regulatory agencies. "I'm going to follow the FDA. They're our agency," said a physician quoted in the WSJ article. Unfortunately, under the current drug safety regime at the FDA, such trust may not be warranted.

Friday, February 11, 2005

Time for Pharma to Revamp Its Physician Marketing Strategy

Should pharma companies revamp their physician marketing strategies? Some idea of pharma's thinking on this topic is revealed in the emerging story of Pfizer's plans for its own sales force.

Today in the WSJ, for example, appears an article about Pfizer's plans to change it's method of detailing -- marketing and selling to -- physicians. Essentially, the article says that Pfizer plans to "reverse a decadelong infatuation with multiple sales forces pitching the same products to the same doctors." (See "Pfizer Plans $2 Billion in Cost Cuts," WSJ, 2/11/2005). This refers to the use of sales rep "pods" in which several reps coordinate visits to the same physician to detail the same product (see the article "A Crisis in Professional Detailing" in which two physicians criticize this and other physician sales and marketing tactics - also see for other Pharma Marketing News reprints on the subject of sales force effectiveness).

Familiarity Breeds Contempt?
The article goes on to state: "In the recent past, it hasn't been unusual for six or more different Pfizer representatives to pitch the same doctor on heavily marketed products such as Celebrex. The industry theory behind these multiple sales forces is that familiarity breeds contempt. [my emphasis] Different faces have better odds, the dogma goes, of getting into the doctor's office than the same representative calling more frequently."

If you read the above cited Pharma Marketing News article, you will see this comment from a physician: "It is much better to have one rep who is valuable, who has a relationship with the office staff, and knows when it’s a good day or not a good day to see me, than to have ‘storm trooper’ representatives coming to the door."

Relationship Marketing
It's not clear to me whether the familiarity breeds contempt "dogma" cited in the WSJ article is something Pfizer or other pharma companies actually believe or if it was made up by the author of the article. Regardless, there is an emerging marketing technique called relationship marketing that relies on the exact opposite dogma, namely that familiarity breeds increased loyalty and sales, certainly NOT contempt.

I think the idea of sales "pods" and multiple reps calling on docs about the same product has more to do with an older notion of marketing: reach and frequency. With sales rep pods, you can reach more physicians more often. It's equivalent to bringing mass market advertising to physician marketing. However, just as this technique has cluttered the consumer marketing landscape with messages that are ignored and have little impact, when applied to phyicians, it has lead to "lack of physician access" bemoaned by the industry.

Relationship marketing also embraces the idea that you have to build upon previous contacts with the customer and modify your message according to unique customer behavior. Docs would like to see a progression in the information that reps deliver. A lot of times reps come in and start at the beginning with the same message. It would be much better if they built upon what they covered a few weeks ago.

Perhaps pharma companies should consider how to better employ relationship marketing techniques in order to improve efficiencies. There is a question, however, whether pharma with its silos of information can effectively employ relationship marketing (see "Out-of-the-Box Marketing: Will It Work for Pharma?").

Also important is sales rep preparedness and ability to teach. Unfortunately not every representative has the ability to teach and some just push the sales aid. It's not just a matter, therefore, of implementing a new technique in marketing, it also involves changes in sales rep management and training.

Thursday, February 10, 2005

Pharma Sales Force Bloat and the Mythical Man-Month

A myth long believed at pharma companies --as well as at other companies -- is that by by hiring more salespeople you can proportionately increase sales without limit. Want to double sales? Hire twice as many sales people.

Unfortunately, it doesn't work. Everyone knows that pharma sales reps are less effective than they used to be (see "A Crisis in Professional Detailing"). The increase in the number of sales calls is not proportionate to the increase in number of sales reps. Although the pharmaceutical sales force has doubled between 1995 and 2000, the number of audited calls has only increased by 10%. Realistically, reps average only 2 quality details per day (quality details includes discussion of features, benefits, and data). The reps have less time per call, are only able to deliver incomplete messages, and aren’t able to really differentiate their product from the competition’s.

Pharma companies should have taken a lesson from the classic book "Mythical Man Month," which explained why throwing more people at a problem often makes the problem worse.

The book tells the story of how an IBM operating system was developed. When the project got behind schedule, they would add more programmers. They found, however, after a certain point this practice became counterproductive because the amount of communication necessary to coordinate activities between team members -- e.g., meetings -- made the whole process less efficient.

Although you can measure a project by using "man-months," which is the number of people times the number of months it takes to complete the project, men (or women) and months (time, units sold) are not equivalent. Hence, if 100 reps can make 10,000 calls on physicians in a given time period, you should not expect to double the number of calls by doubling the number of reps.

The pharma industry may have fallen into the "mythical man-month" trap. For a time, sales force automation may have masked the problem, but now even the use of technology cannot compensate for the bloat. When times were good -- lots of patent-protected blockbuster drugs, no backlash against drug prices and pharma industry profits -- it did not matter how inefficient the sales force was. Now that market forces are starting to turn negative, the bloat (inefficiency) becomes unsustainable.

Pfizer has recently signaled that it may lay off as much as 30% of its salesforce (see "Pfizer to Slash 30% of its Sales & Marketing Staff"). "What will be interesting will be the responses of Pfizer's competitors," said a member of the PHARMA-MKTING online discussion group in a recent post. "Normally one would expect others to move aggressively to capitalize on Pfizer's unilateral disarmament. I would not be surprised, however, to see other companies doing the same thing."

Another comment from a PHARMA-MKTING member:
"No-one wants to be the first one to back off, but it shouldn't surprise anyone that Pfizer has the guts to do it. Let's hope Wall Street doesn't beat them up too badly for it."
Meanwhile, FierceBiotech reports:
"Pfizer has been hammered on Wall Street by critics who contend the drug giant has failed to add new
blockbusters to its pipeline even as research and development spending continues to rise. The drug maker has annual revenue of $53 billion and a big margin with $16 billion in profits. But with new generic competition on the horizon and questions over its Cox-2 inhibitors savaging sales, analysts believe Pfizer will have to restructure in order to maintain profitability."
Let's see, $16 billion "profit" from $53 billion in sales. If my math is right, that's a 30% margin! That's a great year!

But these Wall Street guys always look on the dark side: "It probably can't get any better next year," the analyst says, "so let's sell the stock!" But Pfizer wants to keep the stock price up, So what do they do? They hint that deep cuts in personnel are on the way. "These cuts will saves oodles of money," says the analyst, "so let's buy the stock!" This has the desired effect as far as Pfizer stockholders and executives are concerned -- an instant spike in
stock prices. "Let's keep the rumor going until April," says Pfizer, "when we can report a good quarter and continue to buoy up the stock price!"

Meanwhile, what are the Pfizer employees feeling right now? They just delivered a terrific year, yet nearly one in three face losing thier job.

O, well! That's the marketplace for you!

Wednesday, February 09, 2005

Pfizer to Slash 30% of its Sales & Marketing Staff

Pfizer Inc. may slash its 38,000-member sales and marketing staff by as much as 30%, or 11,400 employees.
Pfizer Inc., the world's biggest drugmaker, may cut as much as 30 percent of its 38,000-member sales force as it loses patent protection on several key drugs, according to Lehman Brothers analyst Tony Butler, who cited ``industry contacts.'' (Bloomberg, 2/8/2005)
According to a 12/20/2004 AP story:
New prescriptions for Pfizer Inc. pain reliever Celebrex have fallen by more than half since a government-led study linked the drug to an increased risk of heart and strokes two weeks ago. New prescriptions for Celebrex fell 56 percent to 70,760, according to Verispan. The U.S. Food and Drug Administration requested that Pfizer stop advertising Celebrex but data from ImpactRx reveal that the company has intensified its sales calls to physicians. According to ImpactRx, 45 percent of sales representatives' visits to primary care doctors to discuss popular pain relievers were about Celebrex in the three days ended Dec. 20. For the three days ended Dec. 17, the day of the announcement, it was 35 percent. That increased to 55 percent in the three days ended Dec. 22
I guess you don't cut this deeply without a reason. Could it be that they are preparing for bad news about Celebrex in advance of next weeks FDA hearings?

Here are some other explanations offered by members of Pharma Marketing Network and subscribers to Pharma Marketing News:
This could be the signal that starts the great pharma salesforce massacre. On the other hand, I'll believe it when I see the blood in the streets. Seems I just saw McKinnel on record as saying PFE would stay the course. Of course, when the denials are strongest just before events belie them.
-- Terry

I think it's even bigger than Pfizer/Celebrex. I saw a segment on CNBC the other might where an industry analyst mentioned that there was a lot of buzz that pharma marketing and especially the sales forces are next to go (and soon). Pfizer could make the first move, but we can probably expect a much broader trend due to increasing financial pressures.
-- Mark

We are just starting to witness the fat trimming that is about to take place mostly in sales force side then marketing. With 26% decline in sales rep productivity since 1996 when the industry started to fight for Share of Voice and doubled rep numbers to what we have today, something got to give when there is no ROI. This is not going to be pretty picture friends. I was speaking to a CEO of one of the top 5 multinational companies yesterday and he indicated that there is going to be significant adjustment taking place for the industry especially in sales and marketing.
-- Mick

I believe this is going to start the "Domino Effect". It seems to me that they split the sales forces into different divisions to promote different products to the same physicians and added more sales reps to increase the the number of details and actually reached the "Point of Diminishing Returns" some time ago. I think that a lot of companies have needed and wanted to cut their sales forces, but have been reluctant to "Be the First", for fear of the negative PR.
-- Mike
Hmmm... could this be the tremor before the long-anticipated Tsunami of pharma salesforce cuts? Could be. As reported in today's NYT: "Large-scale layoffs from Pfizer may lead to a new period of retrenchment among leading drug makers, with many of them under profit pressure as a result of rising spending for marketing and failures in the last several years to discover medications with blockbuster sales. Other companies would probably follow Pfizer's lead, analysts said." (Some Analysts Expect Job Cuts From Pfizer, NYT, 2/9/2005).

The NYT article goes on to say: "Since 1998, Pfizer and the other drug companies have increased their sales forces by 42 percent, Mr. Sylvester wrote. As a result, doctors are increasingly resistant to visits from representatives, and only 20 percent of such visits result in seeing a doctor."

Declining sales force productivity has been a major issue on the minds of sales managers and corporate executives of pharmaceutical companies large and small for quite some time. More and more physicians are limiting face time and closing their doors to sales reps.

We all see the problem every time we visit our doctor -- looks like Friday night at O'Hare with all the reps circling.

Perhaps the time has come to reassess the pharma sales process and place greater attention on the quality of the physician-rep relationship rather than on quantity-based traditional representative activity metrics such as number of calls per day. (See PMN Reprint: "Finding the 'Right Stuff' to Revitalize Sales Productivity" for more on this subject).

Still, I got to wonder if this portends the imminent withdrawal of Celebrex from the market, which I predicted weeks ago? (See "Cox-2's Die Hard: With a Vengeance").

Wednesday, February 02, 2005

It's the land of success!

Big Pharma had a plan.

It designed a trial for a COX-2 drug and it ran.
Yet it wasn’t enough to get pain low.
What's this?
We’re still here in the land of no?

Fiddle with the randomizing, a doctor said.
The drug’s not to blame.
All clinical trials simply are not the same.
When comparing just the right subjects in a test,
you’ll clearly get an effect that’s the best.
Would you like to try it?
Why, yes. Yes, we would.
Big Pharma took the bait.

Since Big Pharma re-powered the trial,
Its COX-2 CV effects were much less.
With deception and guile,
It’s the land of success.
Reset your trial parameters and you just might declare,
I’m a blockbuster success.
Now you’re getting somewhere.

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