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It's time for the pharma industry to remember that we're here to help patients
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We live in the information age thanks to the Web and portable handheld devices. Often when people wake up in the morning or get to the office the first thing they do is go to the Web to catch up on the news. Stories about pharma have been everywhere and are hard to ignore. There is a transformation taking place in the environment in which we market:
-Customers have more power than ever before and information can no longer be "pushed" to them.
-Transparency at the highest levels is becoming the norm for all industries and CEO's.
-There is a new FDA chairman who is facing intense pressure from a new Congress to implement changes at the FDA including the way the FDA approves drugs.
All this happening at a time when the biggest demographic segment in the US is reaching ages when they are going to need more and more prescription drugs to maintain their lifestyles. Now most DTC marketers will ignore these trends and act like they still need to push the brand message to consumers but I believe this is a big mistake. If customers research and compare detergents don't you think that they would do the same for prescription drugs that they put into their bodies?
It used to be that we could rely on physicians to tell us what drugs we should take but that is changing. Physicians don't have the time to sit with us and talk about medication side effects or choices. In fact research shows that consumers will go to product websites when receiving an Rx to determine if the medication is right for them and examine potential side effects. It has been my experience that one of the top pages within product websites is always the side effects and warnings pages.
Explanation of ongoing clinical trials
So what can the industry do to calm patient apprehension about prescription drugs? Well first the industry has to make clear that all medications have risks. Yes I know that is what fair balance is supposed to do, but it has to be more in a consumer friendly format that is easier to understand like Pfizer has done in their print ads. Second, the FDA and drug companies need to inform and educate patients about ongoing clinical study findings. If for example a new medication causes weight gain in some patients I would want to know that so that I can gauge the risk(s) and benefits of taking the medication.
For DTC marketers these events are going to present more of a challenge. Consumer can no longer be "told" what to buy so marketers are also going to have to be transparent in their marketing messages. Don't oversell the message and inform and educate patients/consumers. Separate promotional messaging from factual disease state messages. Ensure that the message in all channels is consistent and monitor BLOG's and chat rooms for buzz on your products. Listen to what your customers are saying about your drug and find ways to embrace Web 2.0 (if you don't know what this is your already in deep trouble).
There are challenges to be overcome but great marketers know how to turn challenges into opportunities. They embrace new channels and listen to what consumers want and need to make decisions. Pharma marketers need to understand that the environment is changing so rapidly that only those that keep pace are going to succeed.
Product labels negotiations are often intense between the FDA and pharmaceutical companies. The language in the label can lead to increased sales and marketing messages or a very narrow indication which would limit it's use. When negotiating with the FDA drug companies try and incorporate language which can be used to market the product to HCP's and consumers as the label is the "bible" for what can be communicated to patients and HCP's. According to an article this morning in the Wall Street Journal:
In 2000, Diana Levine lost a hand and forearm to gangrene after Phenergan was inadvertently injected into an artery during a so-called push IV injection, which is more potent and puts injected drugs into the body faster than a normal injection. Ms. Levine had gone to a medical facility in central Vermont for treatment of nausea.
The drug's labeling, approved by the FDA, included the injection method as an option but warned of risks like gangrene if the drug were injected into an artery. Ms. Levine sued, arguing Phenergan's labeling was unsafe, and a Vermont jury awarded her $6.8 million in damages. On appeal, the Vermont Supreme Court upheld the award, ruling that FDA drug regulations don't prevent a company from being sued under state law over drug labeling.
You can see why the high court might want to get involved here. The potential for endless litigation is staggering adding hundreds of millions of dollars to costs which ultimately will lead to higher drug prices. Now this author doesn't feel that pharma companies should be immune from labeling language missteps that could lead to patients being endangered but at sometime you have to draw a line in the sand and say "enough is enough". The attorney who is suing Lilly for Zyprexa, (he refused to settle with Lilly) leaked information to the press that even a judge said was reprehensible and the commercials recruiting people for class action litigation can be seen throughout the cable channels. There is no excuse for hiding information or misleading HCP's on a drugs side effects but if this lawsuit is heard by the court and upheld it could open the door to massive delays in new drug introductions. Can you imagine the logistics of trying to prepare different labels for different states?
I am studying law and I love what I am learning but the law is supposed to be about the facts not emotion. I am truly sorry that this patient lost a limb because of the use of the drug but all drugs have risks that is why they have to be approved by the FDA. Patients need to understand that and lawyers need to stop looking to big pharma for a new Lexus or Mercedes.
There is a feeling in pharma that once you have a current patient on your product that he/she is not a valuable asset anymore. Their advertising is focused on people who are not on the brand rather than reenforcing the decision to stay on the brand. The track record for patient compliance for pharma is pretty poor but rather than abandon these customers pharma should embrace them. What made them finally decide to seek treatment" Can we segment this group and identify a common barrier that was overcome? These are all questions that may be answered by current patients but alas pharma marketers seem to turn a deaf ear to this audience.
Let's, for example, look at the ED market. There are millions of men who have not sought treatment for ED because of the psychological barriers. Yet ED brands continue to advertise on TV and go after these men with refined messages. What they should be doing is talking to men who are currently on treatment and ask them "What made you finally ask your doctor about ED?" This way they can identify the triggers to action and utilize marketing channels to deliver messages that address these triggers.
Then there is the CRM component of current patients. Pharma seems to ignore current customers and very few brands, if any, value current patients as a valuable resource. For medications like Lipitor, where patients can't "feel" the benefit of taking the medication everyday, patients need to be reminded that they are fighting bad cholesterol while promoting healthy cholesterol. Yes the Lipitor website has a section for current patients but does Pfizer really believe that people are going to go back to the website, log-on and enter their new numbers? That shows that Pharma is still stuck in Web 1.0 and doesn't understand how people want to use the Web. A CRM program has to be based on a relationship of VALUE to the PATIENT: before someone is going to have a relationship with your brand you have to clearly identify the value equation of your customer.
Listening is a lost art and listening to current patients seems non-existent in most pharma DTC programs. Yet listening to your current patients can provide a wealth of information to your brand.
1. Pharma brand.product teams will be reduced in size- There is no need for a lot of people across the brand team. P&G managers manage billion dollar brands with and the same will happen in pharma with regulatory, legal and medical personnel working across several functional areas.
2. Pharma sales forces will continue to be condensed - Physicians don't have enough time to meet with the reps so they eventually pharma will realize that they cannot afford such high priced sample deliverers.
3. The Internet will be embraced more for both DTC and DTP initiatives- Sooner or later marketers will wake up and realize the the Web can drive business successfully if used correctly.
4. The FDA will limit DTC but product website will not be considered DTC unless they become overly promotional- Pharma will have to add more credible information and less promotional information to get past FDA reviewers.
5. TV will become less important in the DTC mix.
6. At least 3 CEO's from top 10 pharma will step down in the next two years.
7. Some colleges will offer a medical degree for those people who don't want to practice medicine but who will need an understanding of medical principles in their careers. This will be driven by the need of pharmaceutical companies who will need marketers with more knowledge of medicine to market new drugs.
8. Smaller companies that are able to respond to market place challenges will be more successful and deemed more credible by physicians.
9. Vendors/agencies will be out...strategic partners that have quantitative measurement criteria will be in.
10. More venture capital money will flow into small biotech companies that are developing new drugs with hopes that if successful they will be purchased by big pharma.
11. eMarketing people, people who really deeply understand the Internet, will be in high demand while traditional media people will be looking for work.
12. Pharma will eventually embrace Web 2.0 at a time when other marketers are embracing Web 3.0
13. There will be more reports of medications causing problems with continued use that will lead to more litigation from the bloodsucking legal profession.
14. When Viagra comes off patent sales of Cialis and Levitra will decline rapidly.
15. The days of big salaries and bonuses at pharma will be coming to an end. The pressures on pricing and promotion will continue to force pharma to more performance enhanced compensation models.
Lilly went through this when their top selling product Prozac came off patent and Pfizer is preparing to lose it's $10 billion drug Lipitor to patent expiration in the near future. Pfizer tried to develop a follow up product to Lipitor but after some early negative press they decided to pull continued development. This is another example of relying too much on one product to drive sales and profits. Investors for many years have been told to "diversify" their portfolios but in the pharma business it seems to be "milk the product and drive sales for every dollar we can get back".
Today's New York Times, in its Editorial section, called for an end of the practice of pharmaceutical companies reimbursing physicians for using their products. It is of course legal to do so but this is a case when following the law may lead to the bad practice of payments driving off label or high use by the medical community. In any case the pharma pricing people are going to have to formulate new pricing models that allow drugs to succeed while limiting payments to physicians who prescribe them. Of course the reason that these payments are so important is that our current health system does not allow adequate, in some cases, cost reimbursement for using these drugs but as long as there is money to be made by prescribing them you can bet medical practices will count on these dollars towards their bottom line.
There a lot of issues with the cost of pharmaceutical products and what I have presented here is a simplification of one of the issues but what I am so puzzled about is how these high paid CEO's continue to earn the big bucks without the ensuring that their companies are financially sound even if they lose their biggest seller. It's called scenario planning and in this case Amgen may be caught with their pants down. When I was at Lilly and we lost the Prozac patent we immediately implemented a plan called Year-X in which ALL expenses were curtailed, raises were kept to a minimum and bonuses were put on hold. The result is that Lilly is slowly rebounding although this author feels that they are relying too much on Zyprexa sales which were $2.4 billion last year.
During World War II, as the allies were driving deep into Germany, General Patton prepared for a major offensive by German forces. Many commanders felt that essentially the war was over and that the troops would be home for Christmas, after all the German army was finished and they had never mounted a winter campaign since the days of Fredrick the Great but Patton felt that the data he looked at supported an attack by the enemy and prepared scenarios for a response. CEO's in a sense are commanders and even in good times, especially in good times, they need to anticipate worst case scenarios and be prepared to react with speed to ensure that their company can weather the storm. It's time for them to earn those salaries not to retire with millions in stock options.
This plea agreement is a sham and for Purdue pharma will be just another expense on the balance sheet. Oxicontin has made billions of dollars in profits over the years and the government should have gone after Purdue where it really hurts..their pocketbooks. I mean here you have a drug company admitting that they lied and as a result putting patients health in jeopardy. This is more than unacceptable this is an outrage and these executives need to go to jail to be held personally accountable. Yes they were each fined but I am sure the company will help them out with that or that they will cash in some of their options to cover the fines.
I
would not have accepted the plea agreement I would
have proceeded to trial and alerted opposing counsel
that their clients had better get used to group
showers and wearing orange jump suits. I would have
appointed somebody from the FDA to personally oversea
ALL of Purdue's marketing material for the next 5
years and then I would have confiscated the profits
from the product for the periods in question. This is
the only way to deal with people who put profits
ahead of patient health especially when they commit a
criminal act and lie about it. It's time to get
tougher with weasels.
Documents in a lawsuit filed against Johnson & Johnson by two former salesmen show how the pharmaceutical giant sought to boost sales of its blockbuster anti-anemia drug Procrit by offering contracts that fattened doctors' profits and urging its salespeople to push higher-than-approved doses. According to todays Wall Street Journal;
Dean McClellan, who worked for 12 years at J&J's Ortho Biotech unit selling Procrit, saved 15,000 pages of company memos, contracts and other work-related documents in a storage unit and shed he built off his garage. He says he was forced to retire in 2004 because the company told him his sales increases weren't high enough. He believes the company wanted him out because of his age, which was 55 at the time. Angry, he agreed to join a whistleblower lawsuit by another former Procrit salesman, Mark Duxbury. A brief filed by J&J says Mr. Duxbury was fired in 1998 for racial and sexual harassment. Through his attorney, Jan Schlichtmann, Mr. Duxbury says he was a star salesman for Ortho whom the company turned on after he told the truth about their business practices at a court-ordered deposition.
l.The Office of Inspector General of the Health and Human Services department put out new compliance guidelines in 2003 saying that marketing the spread may be in violation of anti-kickback laws. The Justice Department has been investigating drug companies for such marketing practices, resulting in big settlements of $875 million for TAP Pharmaceuticals in 2001 and $355 million for AstraZeneca in 2003. After extensive debate, Congress overhauled the Medicare reimbursement system in 2005 to prevent such practices. But drug companies continue to offer large buyers big rebates, which they say are lega
Mr. McClellan's documents on the marketing of Procrit show that in 2004 -- after Amgen Inc.'s competing drug Aranesp came on the market -- J&J made offers that would allow buyers of Procrit to receive discounts off an already-reduced price as well as rebates. For example, an internal company memo calculates that a physician who bought nearly $1 million of Procrit over 15 months would get a check for $237,885 back, or 24%.
.Another J&J program offered hospitals an incentive to buy Procrit and shun Aranesp: discounts on purchases from across Johnson & Johnson's product line -- including some huge-selling drugs and medical devices sold by different subsidiaries -- if the hospital used Procrit at least 75% of the time when prescribing anti-anemia drugs. In addition, J&J created a "Right of First Refusal" contract for doctors, requiring them to allow Ortho Biotech to make a counteroffer if Amgen's Aranesp price undercut Procrit
Mr. McClellan also alleges the company pushed doctors to prescribe a higher dose years before it was approved as safe and effective by the FDA. For years, the company focused on educating health care providers on Procrit's medical benefits, he says. But in the mid-1990s at a national sales force meeting, an Ortho executive announced that the division was moving to promote what it called "QW dosing," switching patients from three, 10,000-unit doses a week to a single, 40,000-unit dose in cancer patients, Mr. McClellan says.
At that time, that dose wasn't approved for cancer patients. Many years later, the FDA approved the dose in cancer patients, but before then, pushing the unproved dose would have violated FDA rules.
Where the hell was management and where the hell was ethics in all this? Hidden under the financial calculator no doubt. And does the pharmaceutical industry really believe that stories like this won't circulate among patients and HCP's? Does the pharma industry really believe that patients are going to continue to "buy-in" into DTC for new products with a track record of "profits over scientific benefits"?
The successful new CEO knows that everything their company does is transparent in a world where information is readily available. Unfortunately the pharmaceutical industry continues to set standards of bad conduct in pursuit of the almighty dollar while pretending to be concerned about patient health. Take notice marketers: the public is not going to buy this anymore and marketers can no longer tell people what to think and buy.
If there is anyone naive enough to believe that, when drugs are being developed, drugs are marketed because they provide better health solutions then there is a bridge I want to sell you really cheap. Drug development is a business decision, that means that the key driving decision as to whether the drug will continue in development is the potential for sales dollars not "how many patients will it help". I know of at least two drugs in development at major pharmaceutical companies and what is being discussed internally is the potential for "off label sales". The sales people know that regardless of what the label says that a number of physicians will use these drugs off label and could add hundred of millions of sales dollars to the bottom line.
On the other side of the coin I also know of a drug that could be used to prolong the lives of patients with a certain type of cancer but that these drugs are getting reduced funding because the sales potential is very low. So what does all this mean? Well it brings us back to the age old paradox: is profit the underlying driver in pharmaceutical business decisions? But first let's take a step back here...Chrysler is for sale because of sagging sales and because the models they have introduced have little consumer appeal. When an automobile company decided to take a concept car to production they have to determine their break even sales point and project how many units need to be sold in order to maximize investment. This is traditional, standard MBA analysis. The difference is that these are cars, or SUV's that take people places they are not products that could save or enhance lives. Ahhhh, there's the rub...profit or patients health...shareholders or customers?
I'll be the first to admit that it's not easy being a CEO today. You have to please board members who look at a companies financial sheet for quantitative measurements of performance. Wall Street analysts can swing hundreds of millions of investor dollars to or from your company depending on what they want to hear and the regulatory environment is getting a hell of a lot tougher. Still, if I was earning millions of dollars a year and was guaranteed a golden parachute I would embrace this challenge. The problem seems to be, as I have written many times before on this forum, is that there is a real lack of business leaders in American industry today. Bill Gates is semi-retired and Microsoft has become a huge, slow bloated company, Steve Jobs is still a driving force with Apple but then again his compensation is valued well over $600 million and the auto industry compensates a new CEO from Boeing $24 million to report record losses and lay off thousands of people.
So what does all this mean for the pharmaceutical industry? Well first the company slogans don't mean a thing. "Answers that matter" should be "answers that matter for a price", "where patients come first" should be "where patients come first behind Wall Street, "working for a healthier world" should be "working for a healthier stock price". Pharmaceutical companies are public companies and as such have a responsibility to earn a return for investors.
George Merck in 1952 said "Medicine is for people, not for profits.” I think that too many people in the industry have forgotten that and as long as they do the pharmaceutical industry will continue to go blindly into the mine fields that await them.
I don't believe that at any time in its history the pharmaceutical industry has been facing more challenges than the current environment. Wall Street demands profits, Congress wants accountability, people want real answers to health problems and CEO's continue to be shuffled in and out. As I have written many times on this BLOG before the industry is in dire need of strong leadership. Working in the pharma industry is unique and unless you have spent time on the inside I don't believe that you can understand the environment in which we work. In my 10 years in the pharma and health industry I have seen some amazing things including manipulation of data to support more money for DTC channels, senior managers making decisions about DTC marketing without an understanding of how to measure ROI's and personal agendas that lead to decisions of what is best for the person making them not the brand.
Yet as a pharmaceutical marketer I have chosen to make a stand and do what is right for my customers and patients. Are there that many people out there who purposely hide data from the FDA that could harm patients? Are there managers who make decisions based upon what is right for the balance sheet rather than the patient? The answer to these questions is probably yes. But these managers didn't just come into a company with the idea that sales is more important than patient health. It is started when people don't question numbers or data or don't have the knowledge to ask the right questions.
The pharmaceutical industry is at a crossroads. CEO's need to communicate throughout the organization that whatever else we do the patients always come first. As marketers we all have to put ourselves in our patients shoes and ask "what do they need and want". CEO's have to be strong enough to stand up to MBA Wall Street analysts whose slogan is "instant gratification takes too long" and pharma marketers have to be held accountable for everything they do.
It's easy to point fingers on the outside looking in but frankly there are no short term fixes for any of these problems. It's going to take time at a time when the marketing environment is changing as we speak. What is wrong with pharma is indicative of what's wrong with American Business..too many layers..too much emphasis on paychecks and not enough emphasis on being customer centric.
Mr. Citrin states that in order to excel in the new economy, business leaders need to master six basic strategies:
1. Be capable of doing everything at speed (Pharma marketing has two speeds..slow and dead slow)
2. Create a true learning organization (A lot of pharma companies do have "shared learnings" but few learn from innovators outside the industry. While smart marketers are learning how to leverage consumer generated media, pharma marketers are developing bad DTC).
3. Obsess over the needs of the customer (Like pharma could ever care about the customer. It's all about ROI and driving Rx's not satisfying customer needs).
4. Reward risk taking (FDA..NOV = Trouble...enough said)
5. Learn to live with greater uncertainty (Pharma has no choice and seems willing to let the environment take it where it wants to go !)
6. Master the art of deal making and partnerships (pharma companies don't talk to each other even when it is for the patients good)
Is it any wonder that pharma marketing is looked upon as nonexistent? The more things change the more pharma marketers seem stuck in a rut and it's awful deep.
Legislators in Congress are going to use the Aranesp example of things that can go wrong when bad decisions are made. Amgen's CFO has resigned, or was shown the exit, but frankly that is not enough. Did the CFO hold back the release of clinical trial information because of financial considerations of Amgen stock? If so he needs to held criminally liable as do the other people who were involved in the decision. The CEO must also be held accountable and shown the door as this type of behavior starts at the top and can be inbred through the whole organization.
How can this happen in a world where everything is transparent and paper trails are everywhere? It starts with a belief that shareholders and investors are more important than patients. It tells me that Amgen may talk the talk about patients being important but somewhere the chain broke that people believe that dollars are what drives pharma not successful patient outcomes. I'm sure that Congress is going to have a field day with this one...
The Amgen story that is coming out of Thousand Oaks is going to be a lot more damage to an industry that is already under fire from all sides. People make up a company but somewhere along the way Amgen has hired people who believe that their wallets are more important than patient health and that is beyond reprehensible.
I used to take Celebrex for joint pain until I read information on the Celebrex website that said one of the potential side effects could be "intestinal bleeding or death". When I first received the Rx for Celebrex I received a letter from my health insurer informing me that OTC Ibuprofen (store brand no less) worked just as well as Celebrex and costs a lot less. I switched to Advil but the key point here is that it was MY decision based upon the risks I was willing to take from information on all types of pain relievers.
I know, as all consumers should know, that all prescription medications have risks and potential side effects. I can work with my HCp to determine what is best for me but at the end of the day I am the one who makes my healthcare decisions. To be honest Celebrex worked better for me on my joint pain than OTC products but I did notice some stomach discomfort when I used Celebrex. Rather than risk what I perceive to be more serious problems I decided that ibuprofen will work well while not providing any possible GI problems. I don't want the FDA making these decisions for me I want to make them myself with input from my HCP and no amount of DTC advertising is going to change my mind. DTC ads may enlighten me as to new products or treatment options but I am the one who will go to the product.com website and look at the side effects and warnings to determine if the risk is acceptable for me.
The FDA obviously does not believe that consumers are smart enough to research products on their own even though traffic to health websites, including prescription medications, keeps increasing. Under this new guideline, unmet medical need for patients who have no other "relatively safer" alternatives, products like Ambien might not have made it to the market. If Pfizer informed the FDA that Lipitor, the world's biggest prescription drug, patients were reporting more side effects would the FDA require Pfizer to take it off the market in favor of other cholesterol lowering medications?
This is wrong direction for the FDA to take. Instead they should be working with the drug industry to continually educate and inform consumers about the risks of approved prescription drugs. They should not determine if other "safer alternatives" are available because under that guideline some supplements may work better than prescription drugs with less side effects thus the Rx should be taken off the market. Consumer have the power now and we don't need the FDA to limit the choices WE want to make in OUR treatments.
According to an article in today's New York Times:
But Pfizer’s marketing may not be enough to overcome the medical, economic, practical and legal concerns that have hurt Exubera. In theory, the drug’s biggest advantage over standard injectable insulin is that it is more convenient and does not require needle pricks. In reality, though, the Exubera inhaler is bulky and can be hard to use, doctors say. The device is nearly as large as a tennis ball can when it is open, and must be repeatedly pumped before the insulin can be inhaled. Making matters worse, Exubera doses differ from those for standard insulin, and converting doses can be complicated, the doctors say. Also, insurers have been reluctant to pay for Exubera, which costs about $5 a day, compared with $2 to $3 a day for injectable insulin. In addition, the needles now used for conventional insulin injections are smaller and less painful than they once were. “Out of 2,000 times or more I’ve tried to start patients on insulin, I’ve only been turned down twice,” said Dr. John Buse, professor of medicine at the University of North Carolina.
Marketing 101: Ensure your product is easy to use and understand as compared to the competition. I'm not sure why Pfizer thought that the use of the product would not be an issue for diabetics who currently self inject. Then there is the use of consumer generated media. One person has stared a campaign via the Internet to warn people that inhaled insulin can damage lungs. Pfizer’s clinical trials show that the drug causes lung function to drop in some patients. Again Marketing 101: patients view side effects and make trade offs for product conveniences. Unfortunately Exubera doesn't seem to have advantages over injected insulin.
So now Pfizer is taking their message directly to consumers. Not a good move in my opinion. Physicians don't have the time to work with patients to explain treatment options or how to use prescription drugs. For patients who are used to small, less painful needles the answer might be to just keep on "doing what works" instead of using a new product that requires them to change their lifestyle.
When I first arrived at Eli lilly in Indianapolis I was given a booklet on leadership that was written by our CEO Sidney Taurel. I enjoyed reading the book and made the mistake of trying to embrace some of his principles including the need to "implement with speed". I know that speed is a competitive advantage and organizations have to review processes to streamline them so that they can in fact implement faster. What I found was resistance at every level of the organization and my manager even told me to "slow down" to allow people to catch up with me.
Then there was a forum that was help on DTC. While at this forum I was told by a Director that I had to learn more about DTC and I responded "DTC needs to learn more from consumer marketers" upon which there was a loud round of applause from the rest of the audience. When I worked on the Cialis launch team I observed first hand how data was manipulated to show the results that supported more money for television while leaving the Web behind. To this day the website has not changed since I left the company and they are still spending money on TV while the Web site suffers from neglect. By the way 85% of the visitors to our website the first year came from online ads and search engines not TV although I am sure that the two worked together to drive traffic.
Another accurate picture of working in pharma is the endless meetings. Death by meetings is a great way to characterize the atmosphere. Calendars are often booked for weeks at a time and God forbid you just stop bye someone's cube to talk over an idea? For vendors it's even worse with endless presentations and dollars used for trips to Indianapolis only to be told that we had decided to use someone else.
So could it get worse? Well yes....there are a great number of people who I know got promoted to Manager at Lilly that were promoted because of "who they know or how they act" rather than what they did for the company and the brand. This while very talented people continue to transition from careers to jobs and collect paychecks and go through just enough to survive. One author calls them the walking dead and there are a lot of them within pharma. A good leader can transform the WHOLE organization with a vision not just words but I am afraid that this doesn't happen much at big pharma. Companies like Amgen, which had and edge as a biotech company, are hiring more and more people from big pharma as they make the transition to execute by endless meetings and at a snails pace.
Think that this is not true? Ask anyone who works in pharma and chances are that you will hear the stories of long meetings and twisted data (400% ROI on a TV campaign for example). I still believe that out there there are some companies that believe they are in business to help their customers but it looks like that is getting harder to find. Maybe I'm an idealist or maybe I just believe that we can be successful by providing patients with the drugs they need to continue to lead productive lives.
The philosophy behind getting naked is simple:
Smart companies are sharing
secrets with rivals, blogging about products
in their pipeline, even admitting to their
failures. The name of this new game is RADICAL
TRANSPARENCY, and it's sweeping boardrooms
across the nation. Even those Office drones at
Dunder Mifflin get it. So strip down and learn
how to have it all by baring it
all.What would this look like for the pharma industry and what can the companies do to become more transparent? Well for a starter pharma could update their product websites on a regular basis with the results from ongoing clinical trials. In fact there should be a page on every product.com website entitled "results from continuing clinical trials". Rather than report the scientific results however the results should contain a simple to read abstract so patients can understand the data. Is this risky? You bet but I would imagine that the litigation commercials for Zelnorm, now that it's been taken off the market, are only a few weeks away from airing.
Pharma needs to inform the public that even though the FDA has approved a drug that continuing clinical trials may indicate that there are other side effects and risks. Might this scare people away? Hell yes but transparency is a philosophy that in the long run can enhance a brand or company.
New products are often talked about at investor meetings but unless consumers are willing to dig real deep it's hard to find within a companies website. Yes pharma is restricted in what it can say (claim) about new products but allowing the public access to the initial data can lead to customers becoming working partners. Before we received approval on Cialis in the US for example there were a number of websites talking about the new products benefits among men with ED. Just look at all the insights that are surfacing on the Internet about political frontrunners Rudy Gulianni and Barrak Obama.
Every manager needs to learn how to manage risk but the CEO and senior managers need to set the trends of what is acceptable risk and what is not acceptable risk. Pharma needs to start opening up more to customers and especially the media who has been extremely critical of the industry. It's time to understand that secrecy is dead and the sooner that pharma understands this the sooner they will be able to become better companies that are customer focused.
Let's start with Eli Lilly & Company. Sidney Taurel pulled down a total package worth more than $15 million yet look at Lilly's performance vs. the S&P 500.....
Lilly has never recovered from the loss of patent
on Prozac and now Zyprexa sales have reached a
peak.
Pretty dismal ha ?
If this is a scorecard for the CEO's performance
then I think it's a pretty sad shape of things
overall. The stock options that I received at Lilly
over 7 years ago are worthless and Lilly has never
recovered from the loss of patent on Prozac (the
contingency plan was called Year-X and was not
strategic at all) and now Zyprexa's days as a
blockbuster are numbered.
What about Pfizer? Surely a company that markets
Viagra and Lipitor can beat the S&P ! Think
again... The recent clinical trial setback for
their new cholesterol drug and generic competition
looming for Zoloft and Lipitor have hurt the pharma
giant while Jeffery Kindler pulled down a
compensation package of more than $9
million.
Pfizer's performance has been
dismal
Amgen is another
company, that until recently, had been doing very
well. The recent coverage of Aranesp has really
hurt their performance and the FDA has informed
Amgen to halt all DTC advertising (they weren't
doing any ?). Kevin Sharer the CEO of Amgen had a
lot of money to play with for the high cost of
living in California. His package was over $24
million !
Amgen has really been hurt by the recent
Aranesp problems
There have been
some companies that have managed to do well against
the S&P 500. Wyeth, whose CEO made a whopping
$32.9 million was one of those companies. However,
one has to ask if a compensation package over $32
million is worth this
performance?
Wyeth has had some bumps in the road but
is performing well.
Kudos go to Mr
Cornelius of BMS. His compensation was more
reasonable in all this madness at only $1.5
million. I can tell you that in New Jersey that's a
good salary but not one that could let you live as
a king. It all comes down to a philosophy of
shareholders and the board:
"Are we here to
please Wall Street and increase shareholder value?
Or are we here to provide patients with medicine
that can extend lives and ensure that we live a
better quality of life?"
I for one believe that there is too much focus on trying to keep Wall Street happy and not enough focus on people. These two philosophies can coexist but it requires someone with foresight and vision to lead the charge. You would think for the money these guys are pulling down they could at least try and lead...
It's not easy to be a CEO of any big company today. There are always people who are second guessing what you do and Wall Street can be relentless in its pursuit of earnings. But how many people who are senior level managers would gladly take on the challenge of leading a major company for a lot less money? My guess is there would be a lot of volunteers.
What are the qualities needed to be an effective pharma CEO? Here is a list of some attributes I believe every CEO needs to be successful:
-Lead don't follow: Set a clear direction for your company and don't bow to pressure from the outside. Strategic direction is an important framework for the health of the company.
-Listening: Listen to the life's blood of your company; your employees. Listen to what they are saying and implement changes to allow them to succeed.
-Implement with speed: Pharma is moving at 20 mph while customers are moving at 100 mph. Pharma has a huge competitive disadvantage here.
-Be a great salesperson: sell your ideas to your senior managers, ensure they understand and get rid of the ones that are resistant to change. Sell your vision to Wall Street and to the Board. Make sure they are willing to support your decisions.
-Be a marketing driven organization: The days of the big pharma sales force are coming to an end. Physicians don't trust pharma messages and consumers are taking control of their healthcare decisions. This all means that you had better learn to change your business model from a sales driven company to a marketing driven company quickly.
-Embrace the Long Tail: Blockbusters are going to be few and far between. Diversify your portfolio to include a lot more products that produce sales of $200-$700 million rather than one product that may account for a big part of your revenue.
-Prepare for coming storm: Lead your company through the coming storm that is being generated by the media and Congress. Have plans in place to so that they can be executed at a moments notice.
-Mingle: Sit down with your employees at the cafeteria. Talk to them, listen to them, get them to open up.
Sounds simple but it's not. There are way too many CEO's who sit in their big offices and have a "town hall" meeting with employees and believe that is all they need to do. When I was at Lilly I tried to follow Sidey Taurel's book on leadership and ran into brick walls again and again. If your vision is not communicated and enforced at every level of the organization your spitting into the wind. It's time for changes in compensation and a new face for pharma CEO's to emerge.
I have worked with a lot of physicians and I can tell you that for most of them unless there is some type of compensation for their time they don't want to get involved. Take online detailing for example, most research clearly shows that a majority of physicians will only participate in online detailing if there is some type of compensation involved. When we don't offer compensation the response rates are minimal.
Is the article one sided? Well look at this quote...
“Drug companies are like lions,” Dr. Grimm said of his sponsored talks. “For lions, it’s their nature to kill zebras and eat them. For drug companies, it’s their nature to make money. They’re not really trying to improve anybody’s health except if it makes them money.
So according to the NY Times they are to ask doctors to speak on their behalf about medications for no compensation. Drug companies have already stopped the practice of spending sprees on lavish resorts but the truth of the matter is that physicians want to hear from other physicians. Can they be impartial when they receive payments from pharma companies? My guess is no but don't you think that they have to believe in a product to pitch it or does the Times believe that all physicians are for sale?
Among the key findings of the report:
Industry Ignored: While covering everything from medical “controversies” to breakthroughs, nearly 80 percent of the stories excluded the viewpoint of the pharmaceutical industry, failing to include either a company statement or a company spokesman.
Media Overemphasize Cost to Consumer: The broadcast networks mentioned costs to consumers or drug company revenues 11 times more often than they mentioned drug development costs.
Networks Leave Companies Unnoticed: Only 22 percent of the stories even named the company that developed the drug or drugs featured in the story.
What Development Costs?: A mere 2 percent of stories dealt with the cost of developing drugs, and even those costs were downplayed by industry skeptics.
Special Treatment for Left-Wing Causes: Nineteen stories focused on drugs that were popular liberal causes such as the morning-after pill or HPV vaccine Gardasil. The networks didn’t apply the same scrutiny to those drugs and their makers as they did to others.
Surprised? You shouldn't be. What should surprise you is that the pharmaceutical companies will spend millions of dollars and thousands of man-hours to research positioning statements or DTC messaging but when it comes to communicating the challenges the industry faces to the general public the lack of noise if deafening. How many millions of people are leading better quality lives because of prescription medications? How many people are adding years to their lives because of prescription medications? A diagnosis of HIV is no longer a death sentence. People who have cancer are living longer and beating back this horrid disease because of the prescription drug industry. Yet papers like the New York Times continue to report one sided stories which is scary because too many people believe what they read without challenging information.
Again I believe that a leader needs to emerge from the pharmaceutical industry to state the facts and defend the industry. He, or she, needs to remind people within the industry that we are here to benefit patients and to never lose sight of that. But more importantly this leader needs to tell the instant gratification people on Wall Street that the industry will continue to devote resources to new product development and if short term profits could take a hit at the expense of strategic or long term company health. Help Wanted ...now !
For copies of the report send me an email
There is a fine line between cooperating with the FDA and tucking your tail between your legs and kissing someone's ass. If the FDA mandated that CEO's wear clown suits I believe they would comply ! The battles looming with the FDA are all politically motivated and the new head of the FDA has shown that he is going to play along with Congress and do whatever is necessary to get in their good graces even if, in the long run, patients are hurt. Make no mistake about it patients will be hurt. Amgen alone lost $18 billion in market capitalization when the black box warning was issued. That means less money to investigate new drugs and less products in development.
There have been accusations that the FDA is too cozy with big pharma. I frankly don't buy that for a second. The FDA is understaffed and overworked and has to rely on a good relationship with pharmaceutical companies to streamline work loads. Drugs that may have received approval through the normal NDA process are now being held up because the FDA wants "more clinical studies". Most pharma companies work with the FDA while a drug is in development to ensure that protocols and studies are set up correctly. The problem is that once the data is submitted via a NDA the FDA can use subjective criteria and tell the company that it now wants more studies. The pharma economics of this long process means higher development costs, less revenue and will lead to higher drug costs across the board.
Rather than point fingers it's time for pharmaceutical companies to ban together and come up with a plan to better work with the FDA, Congress and the media. Lobbyists are not the answer pharma needs to remind everyone of the value they provide to society in the form of better health and lower health care costs. Pharma will spend billions on DTC message development but not one leader will step forward and reach out to other industry leaders with a plan that clearly addresses the challenges facing the pharma industry today. Help wanted....
The move comes as the FDA is under pressure from Congress to show that it is focusing on drug safety, in the wake of a series of incidents including the market withdrawal of the painkiller Vioxx. FDA officials said the black box was sparked by recent studies that have pointed to risks tied to the drugs, particularly when doctors used them for very aggressive treatments. Karen Weiss, deputy director of the agency's office of oncology drug products, said the "bulk of the data that has raised concerns" came when patients were given higher-than-recommended doses, whether they were suffering from anemia tied to kidney problems or cancer treatment. The evidence is that "this type of strategy is not beneficial and in fact has some evidence of harm," she said.
Pushing hemoglobin to levels as high as 13, 14, or 15 -- done by physicians acting on their own against label recommendations or by researchers testing benefits of more intense treatment -- carries a heightened increased risk of death, or serious cardiovascular events. It also may lead to faster tumor progression of head and neck cancer in patients on radiation, as well as shorter survival and increased deaths of advanced breast cancer patients receiving chemotherapy.
So what we have here is is:
1: The FDA trying to please Congress by showing it is proactive in a potential issue.
2: The FDA overreacting because the majority of this off label use is done by physicians acting on their own against label recommendations.
Have the pharmaceutical companies benefitted from this off-label use? The answer to that of course is yes but unless there is undeniable evidence that Amgen & J&J promoted off-label use why are they being held accountable for the actions of physicians? This is what is happening to the pharmaceutical industry and is in the end is going to lead to higher drug development costs as well as higher costs for prescription drugs. The original study that started this whole debate was a study in which Amgen's drug was given at higher doses than recommended and for indications for which the drug label did not support.
If this is the new leadership of the FDA than God help us all. This is not what a leader does this is what a politician does. This action is shortsighted and politically motivated and one has to wonder if this is going to be the new direction for the FDA.
An insomnia drug would compliment Lilly's portfolio of neuro drugs but with Ambien the clear market leader I just don't see any new product making a substantial gain into this market. Lilly has never been known as a marketing powerhouse and in fact they are more a sales driven than marketing driven company. Lilly has spent more than $300 million in DTC for Cialis yet it's market share here in the US remains below 30%. Could Lilly have reached the conclusion that there are no more blockbusters and it's better to have a broad range of products bringing in $200-$300 million than one product bringing in $1-$2 billion ? Diversification would certainly make sense. Lilly has never quite recovered from the loss of patent to Prozac and Zyprexa's sales may have reached its peak.
So in addition to a crowded markets for treating cholesterol we will soon have a very crowded market for insomnia drugs with a range of products to chose from. Hypnion only employs 25 people and I am sure that this is not a major acquisition for Lilly like the recent purchase of Icos but in order to make this produce even moderately successful Lilly is going to have to hold onto some marketers who have been leaving the company in droves for greener pastures.
Someone I worked with at Lilly, with a very strong consumer marketing background, is now working as an Associate Sales Director. When I asked why, all I head was "well he realized that in order to advance his career he needed to do a rotation in sales. Bullshit ! That is mindless thinking and should be a warning that the company does not value marketing. I have seen the Lilly salespeople at work and I can see why the sales force is becoming less effective. Sure let's send someone right out of college to a talk to a physician who has spent over 10 years of her/his life learning medicine. Let's keep them waiting in the lobby for 30 minutes so that they can drop off the samples and tissue boxes.
The fact is that doctors just don't have the time anymore to meet with pharma reps. "Just give me the samples" is the rule now rather than the exception. Doctors do so much research on the Internet now that both Google and Microsoft are developing search engines just health care professionals. Still senior managers want that sales experience because they just don't understand the changing environmental factors. It may take 10 years before a "new crop" of CEO's takes the helm at the top pharma companies and is able to change the business models but for now we have a lot of very good marketers out in the field because it's the right thing to do not because it's the right way to address the coming changes. That's too bad because it shows how insulated senior managers are from the reality.
What makes matters worse is that during the DTC conference there is once again an awards dinner. "Let's pat ourselves on the back for a job we feel we did well". This at a time when ED ads are running on "G" rated TV shows and the industry as a whole is coming more and more under the microscope. Where are the innovators? Where are the people who believe that what we do if for our patients not for the bottom line?
I recently heard about a major drug company who is wants to speed approval of a new drug because the potential for off label use is great and could lead to a windfall in sales dollars. This, unfortunately is what drives people at pharma; the pursuit of the almighty sales dollar at any cost to keep the street happy and ensure that the CEO gets his millions of dollars in bonuses. And in the back are the DTC marketers who use the same old marketing programs to reach people with the delusion that someone seeing a Cialis commercial is actually going to make them overcome all their internal barriers to seeking treatment. That people who see an Enbrel commercial are not going to zero in on "the potential fatal side effects" and block the brand message.
Maybe the Democratic Congress is right..maybe the industry can't regulate itself and needs to be "big brothered" by the FDA. I do know that it's time for DTC Perspectives to stop patting people on the back for mediocrity and talk about the issues that people want to keep in the closet.
Who are the drug companies? They are not huge buildings on a hill with all the warmth of an ice storm. Companies are made up of people but somehow during the last decade the marketers that have come into the pharmaceutical industry have done a lot of damage.
There is always pressure to make numbers in any company. It's what drives our salaries, bonus and expense budgets. But why would marketers make a bad decision that could cause harm to patients and lead to a mountain of litigation. Knowing the way most drug companies operate, in a matrix environment, I find it hard to believe that any one person could be responsible for these problems. All pharma companies have a process for getting promotional materials approved that involves legal, regulatory and medical support personnel. Unless there is a broad conspiracy by a lot of people these mistakes are the result of bad decisions that are the direct result of people who forgot why we are in this industry.
Bad decisions are a risk in any industry. The auto industry is always in the spotlight for safety issues and it seems that every day there is a recall of some type. Consumer Reports recently had to retract a story it ran on children's safety seats because the company that ran the tests reported the wrong data. All this, along with Tyco, Enron, and MCI, feed into an ere of consumer mistrust of "the establishment". In politics the White House now admits that the information they used to justify the war in Iraq was faulty. More fuel for the fire.
What this means for marketers, and the drug industry in general, is that we now need to redraw the line in the sand and move it more to the right. If there is the slightest possibility that a drug, or device, can cause a side effect we have to report to the FDA and physicians. We can't say anymore "that we are studying the issue to determine if there is a correlation". We now have to warn our patients and customers that there maybe a link and we are studying the correlation to determine the risk factors.
I also believe that more checks and balances are needed in the promotional process. People who approve promotional messages need to clearly indicate that they are approving these materials with documentation. Brand team leaders should be help accountable for everything that comes out of the brand including DTC and HCP materials. More than anyone these people need to be made aware that the environment in which we market is hostile and one bad decision could cost the company millions of dollars in lawsuits. More importantly the industry needs to be reminded why we are here: to make a difference in patients lives.
We all receive annual reviews and it has to be up to management to weed out marketers who make questionable decisions. The industry has to be more proactive in cleaning house because if we are not Congress will be glad to do it for us and the results will not be pretty. In recent research that I conducted with diabetics I learned of the problem these people had with living normal lives. It reminded me that I need to do whatever I can to help these people and provide answers to their concerns. Maybe it's time for everyone to listen more to patients and less to Wall Street to get back on track.
The Times did a great job of reporting the leaked documents in front page and front business page stories, Rather than question the motives of the attorney who leaked this information the Times chose to point fingers. While it is true that any neglect on Lilly's part to hide the weight gain issue is inexcusable the reporter obviously felt that the millions of people who have taken Zyprexa, and are leading better lives, were not worthy of mentioning. He also seemed to leave out the motives of the attorney who is in litigation with Lilly over Zyprexa. He was obviously looking for a huge payday and wanted to pressure Lilly into a settlement.
This story of the injunction was not covered in the Times, at least anywhere that this author could find. The Times has an axe to grind with big pharma that much is obvious from its editorials and continued negative stories. It should however offer readers better coverage and more balanced reporting than this. When I read the Times I now question all their stories and with each one a great newspaper becomes more ordinary.
In an important change, cancer patients' own assessments of how a drug is working, called patient-reported outcomes or PROs, are increasingly part of the drug-approval process at the Food and Drug Administration. The agency says PROs have been integral for the approval of a number of cancer drugs in recent years, including Amgen Inc.'s Kepivance for severe mucositis, mouth sores that are a side effect of cancer treatment, and Axcan Scandipharm Inc.'s Photofrin, an agent used in treating precancerous lesions in Barrett's esophagus.
There have been calls by researchers to add PROs to reports of drug toxicity that are used during clinical trials, something traditionally reported only by clinicians. There is even emerging evidence that, for patients with advanced cancer, a patient's self-report about how he is feeling is a better predictor of how long a patient will live than other standard clinical data.
Traditionally, patients' quality of life or well-being while on a drug has been a secondary consideration, rated and reported by researchers. But one recent study demonstrated that clinicians tend to underestimate subtle signs of problems that patients can pick up on earlier; patients reporting numbness in the hands or feet, a symptom caused by some anticancer drugs, were able to detect the problem months before the clinician reports did.
The shift toward PROs is important for cancer patients, whose opinions now play a much more significant role in determining the success of a drug. It is driven in part by the growing influence of the patient-advocacy movement. But it can also be valuable for drug companies, which often invest huge sums of money in drugs that fail because they can't demonstrate that the drugs extend a patient's life. With the emerging role of PROs, drugs that don't necessarily extend life but make the patient feel and function better have a better chance of winning approval.
PROs have long been an integral part of trials testing new drugs to treat conditions such as arthritis, where patients are the most accurate source on whether a product relieves pain. In cancer trials, though, whether a patient lives longer has long been the central measure by which a drug is judged. However, in recent years, the reality began to sink in that there weren't many new cancer drugs that dramatically extended people's lives. The FDA increasingly began to acknowledge that giving someone a higher quality of life offered clinical benefits that could lead to an approval.
What drug companies and FDA both realized is that "changes in tumor size do not always conform with improvement as perceived by the patient," says Laurie Burke, director of study endpoints and label development in the Office of New Drugs at FDA.
Eli Lilly & Co. has used PROs in the regulatory process for its drug Gemzar, approved for pancreatic cancer in 1996 and ovarian cancer in 2006. In the 2004 approval of its Alimta drug for lung cancer, PRO data were critical in showing that the new drug not only shrank tumors as effectively as the existing treatment, but had fewer patient-reported side effects. "PROs are now a standard part of our Phase III cancer drug trials," says Astra Lipa, senior health outcomes scientist at Lilly.
Patient-reported data are also becoming more important in determining which approved drugs oncologists will prescribe -- especially important given the high price of cancer drugs. At a meeting of American Society of Clinical Oncology in Atlanta last year, Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. made a point of presenting patient-reported data on their new kidney-cancer drug Nexavar, demonstrating the drug improved the way patients perceived their own health-related quality of life. (In the case of Nexavar, the PROs weren't submitted for the FDA approval process because the trial had early success and there wasn't time to evaluate those data. The drug, the first new kidney-cancer treatment approved in a decade, was shown to double the time before the disease got worse, compared with a placebo.)
Last year, the FDA
issued a set of guidelines as to how the agency
will evaluate PROs during drug approval; the final
version is expected to be issued in the coming
months. The guidelines emphasize that patient
responses should be relevant measures of whatever
is being tested, and raised concerns about the
credibility of the PROs in cases when patients know
they are getting an active drug, because patient
responses are subjective.
In a 2005 paper published in the Journal of the
National Cancer Institute, a group of researchers
associated with the Radiation Oncology Therapy
Group studied whether short-term radiation therapy
was as effective in alleviating pain in patients
with cancer that had spread to their bones as the
standard course, which was longer and involved
higher doses. By asking patients to rate how much
pain they felt and how much pain medicine they
needed, doctors concluded that shorter and lower
doses of radiation were just as effective. Deborah
Watkins Bruner, one of the authors of the study and
a professor of nursing at the University of
Pennsylvania, says the trial was a case study in
the way PROs "can provide evidence for important
clinical changes."
The trial also demonstrated some of the challenges
of using patient information: 160 of the 845
patients died or were too ill to fill out
questionnaires after three months of therapy. Even
of the patients who were able to provide the data,
only 84% participated.
Ms. Burke at the FDA, says the problem of "missing
PRO data can't be ignored," and is especially
challenging in a disease like cancer where many of
the patients on a trial are likely to die. She said
the agency was asking companies to start working
with FDA on finding ways to deal with this issue as
early as Phase I of drug trials, when companies are
still only testing a drug in small numbers of
patients for safety issues.
Patricia Ganz, the director of the division of
cancer prevention and control in UCLA's cancer
center, says that all measures of how patients are
faring have problems. Blood-pressure readings can
be different depending on who is taking them. X-ray
results may be interpreted differently by various
radiologists. It isn't always easy to calculate
exactly how much a tumor has grown using CT scans.
In her own research and clinical experience, she
says, "physicians are very poor at predicting how
long someone will live" using standard clinical
information. In a study she and her colleagues
conducted of patients with advanced lung cancer,
she said that patient self-reports of their quality
of life were a more accurate predictor of survival
outcome than physician or laboratory assessments of
prognosis.
David Cella, executive director of the Center on
Outcomes, Research and Education at Evanston
Northwestern Healthcare in Evanston, Ill., says
drug companies aren't going to be able to stray too
far from the issue of whether a drug has an impact
on a tumor. But Dr. Cella, who helped develop the
questionnaire used by Bayer and Onyx in the Nexavar
trials, says he noticed that patients and
physicians often had different priorities in
assessing a drug.
Known as the Functional Assessment of Cancer
Therapy-Kidney Symptom Index, the questionnaire
included questions chosen by both patients and
clinicians. In the final list of questions, the top
eight chosen by patients included whether they were
able to work and whether they lacked energy.
Questionnaire items chosen by clinicians -- and not
ranked highly by patients -- included treatment
side effects, bone pain, shortness of breath and
coughs. Dr. Cella's group has created 10 other
patient questionnaires targeted to specific
cancers.
At Bayer, which supplied a grant to help develop
the new index, Kathleen Gondek, the head of Global
Health Economics and Outcomes Research at the
company, says that "traditional measures" are
necessary in evaluating drug efficacy. But, she
adds, "what we have embraced is the understanding
that how a patient feels and functions may be
equally important."
The experience of Robert Eppinger, 72, demonstrates
how important quality of life can be to patients.
He enrolled in the Nexavar trial in 2005 for
advanced kidney cancer. On the drug, his tumors
have either shrunk or held stable, and although Mr.
Eppinger, a retired office-furniture developer in
Stamford, Conn., said he would prefer a "cure," he
still feels well enough to continue activities such
as going to the theater. "To find out that I could
maintain a relatively normal life began to make me
feel a lot better," says Mr. Eppinger.
Pfizer's recent decision to trim up to 20% of its employees was due to some bad news. First a successor to their blockbuster Lipitor failed in clinical trials and second most of their top sellers, Zoloft & Lipitor, are due to come off patent in the near future. What better way to ensure the stock stays attractive than to layoff people? Eli Lilly recently announced another settlement in the Zyprexa litigation and the completed purchase of Icos, the biotechnology company that they comarketed Cialis with. With all this money flowing out Lilly has had to tighten its belt to ensure that they meet the Streets expectations. To do this I am sure that a lot of programs will be cut including investment in R&D. While this will keep analysts happy now it may mean trouble 5-10 years down the road.
I am an avid reader of business magazines, websites and books and one thing is becoming more apparent to me: great leaders are hard to come by ! CEO's are treated like rock stars with perks that range from private jets to exclusive residences. If they stay on, even for a short period of time, they can leave with golden parachutes that ensure they never have to work again. They know that while they are there their goal is to ensure the stock remains attractive even if it means making bad short term decisions. Have 5 drugs in the pipeline? Well we can only afford to fund two for clinical trials and further development so let's pick the two with the biggest potential for ROI. The problem with model of course is that drugs were never looked at in terms of ROI it was always about patients.
Great leaders have a vision of where they are going and how they want to get there. They are not afraid to go against the prevailing winds and chart a course for new markets. It's too bad that most pharma CEO's spend more time looking at the numbers than with their customers because what we do is so important to extending life and providing a better quality of life. Maybe it's time to remind them that the reason we're in business is for people...not banks.
According to CNN:
.Many practices must tie up $50,000 or more in vaccine inventory, run multiple refrigerators, insure the vaccines and spend lots of time on inventory management. They also must absorb the cost of broken or wasted vials and say that's not possible with most insurers reimbursing at just $2 to $15 over the $120 per dose charged by Gardasil's developer, Merck & Co. of Whitehouse Station, New Jersey "Doctors are drawing a line in the sand on this. They're either not giving it or requiring a surcharge," said Dr. Daniel Schwartz of Broadway Pediatrics Associates in Westport, New Jersey, which charges patients a $25 surcharge per shot. Dr. Jill Stoller of Chestnut Ridge Pediatric Associates in Woodcliff Lake, New Jersey, said the inadequate insurance reimbursement for Gardasil is keeping "a wonderful new vaccine" from many patients. "It really is a shame," said Stoller, who also assesses a surcharge
Pediatricians and gynecologists at solo and large group private practices contacted by The Associated Press said they would, at best, break even if they stocked the vaccine. Most will give patients a prescription to get filled and bring back, but that could cost patients far more. "I don't know where to turn," said Julie Falco, a Marlboro, New York, elementary school teacher trying to get her 13- and 15-year-old daughters vaccinated. Her pediatrician, Dr. Herschel Lessin told her his 20-doctor Children's Medical Group in Poughkeepsie, New York, can't afford to stock Gardasil. Lessin said insurers paying their executives millions won't give him $25 to cover his costs, but will spend tens of thousands if a patient develops cervical cancer.
His practice will provide prescriptions but warned Falco her insurer might not reimburse her and pharmacies might mark each dose up to $200. Falco then tried her gynecologist, who sent her back to the pediatrician. "I still don't have the shot and now I have to decide whether I want to make a $1,200 investment to get them vaccinated," she said. "I really don't want to deny them what I think is right." Dr. Michael Blum, senior partner in a big pediatric practice in suburban Kansas City, said it only provides Gardasil to patients who pay $450 up front, then tries to get insurance reimbursement for them. Only a half-dozen patients have done so.
Dr. Kathleen Moore of AppleTree Pediatrics in Tyler, Texas, said as a solo practitioner she not only can't stock Gardasil but can't afford it for her own 12- and 13-year-old daughters. When she explains the situation to patients, "they all say 'We'll be happy to wait,' because they can't afford to pay for it either."
What a shame that the company whose founder said
". In this case Merck seems to want to put profits ahead of good medicine and that my fellow readers is nothing short of a shame."We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear
One thing I believe about politicians; they will say anything to posture for the media. Logistics don't matter t them, that's someone else's responsibility. Among the provisions of the new bill is a measure to restructure the FDA to create a Drug Safety Center. This unit would have the power to alter labels (including a black box warning) on approved drugs if ongoing clinical studies suggest that there maybe some safety issues. What concerns me about this whole process of development of "new guidelines" is the fact that the senators who developed these programs did not reach out to the pharma industry leaders to reach a consensus that would benefit both benefit and protect patients. They went off into their own little worlds and developed these proposals without considering the consequences of their actions.
As
this author has said all along there are changes on
the horizon for the drug industry but the issues
are complex and far reaching. Poll's continue to
show that the public is getting fed up with
posturing and lip service, they want people to work
together to find solutions for all of us.
Pharmaceutical companies continue to be targeted by
the media and Congress and who can blame them. All
we see on TV are commercials with the CEO of Merck
telling us how the company is committed to
developing great drugs at a time when they are in
the headlines with Vioxx litigation or Pfizer
talking about innovation in new drug development
when they are laying off 10,000 people and have had
a major new drug fail in clinical tests.
Again this author believes that the pharmaceutical
industry needs to circle the wagons and inform a
skeptical public about the expense of developing
new drugs and the number of people worldwide who
are leading a better quality of life thanks to
todays prescription drugs. If the pharma industry
does and says nothing than they had better be
prepared for the consequences that will, I believe,
limit their ability to compete in an increasing
competitive marketplace.
In every industry all marketing programs are being evaluated to determine their potential value for the brand and company. Even the glitzy "up front" promotional week in New York, where media buyers and big corporate people get a glimpse of upcoming fall TV shows, may be discontinued. Although some advertisers are willing to pay $2.6 million for a 30-second spot on the Superbowl others like P&G have decided that the price is too high and they can get a better return on their media dollars elsewhere.
As pharma moves into the next decades the model by which they sell and market their products is also going to have to change. A new younger crop of physicians is entering the workplace and these physicians behavior is much different that their older colleagues. They are aware that technology, such as PDA's, can help them save time and cut down on the maze of paperwork. They want to know more about new clinical trials and successful treatment profiles of other patients. They don't have time for programmed presentations from drug reps fresh out of school.
In a way this transformation will strengthen the industry. Pharma companies are going to have to invest in new technology and hire people who are more medical consultants than sales people so that they can successfully engage HCP's in a one on one meaningful relationship and share information that will strengthen the brand and company. Physicians have the same problem as most of us...we have gone from an age of too little information to too much information. Anyone that can provide them with the information that they are looking for will be seen as adding value, versus those people who come in to drop off samples and tissue boxes.
I saw this coming many years ago when, at Lilly, I observed sales people coming into our HQ's for training. Most were what I called "kids" fresh out of school and I thought to myself "how can they relate to a physician who maybe in his/her 40's or 50's and have a meaningful conversation?" Yes there was a time when it was about lunches for the staff and trips to top resorts for physicians but those days are gone. For a lot of pharma companies the future has arrived but the door is only now starting to open.
How many marketing people does it take to market a new prescription medication? At most pharma companies probably too many. When I was a product manager for consumer electronics I had direct responsibility, including P&L, for over $500 million in sales. What I have seen is that most brand teams within a pharma company have four people to do a job that can be done by one.
Here is what I believe you need on a branded pharma marketing team:
-Product Manager: Overall direct responsibility for the brand including financials, marketing and sales. Has to ensure that message development is integrated within the brand team members.
-Health Care Professional Marketing Manager: Responsible for marketing to HCP's including message development and evaluation of branding within the HCP area.
-Medical Marketing: Thought leaders & CME development.
-Patient Marketing: DTC Marketing execution to targeted patients.
The other support functions, such as medical, regulatory, legal, business to business and PR should be resourced to be cross functional so that they can support other brand teams. However, they could be grouped by speciality such as Neuro or Oncology. Of course there are some things that would have to happen to have such a small team. First pharma would have to allow agencies to become more of a strategic partner so that they can do what they were hired to do without micromanaging managers. Agencies would become an extended part of the brand team and be held accountable to quantitative measurement criteria just like other areas of the brand team. The Product Manager would have to shoulder the responsibility for the brands financial targets including the direct management of profitability and expenses.
With such a small brand team something else might happen that would surprise a lot of people...implementation with speed and quality (now that's novel isn't it!). You wouldn't have to have a dozen meetings to coordinate information within the team. When you give more people direct responsibility for their jobs a remarkable thing happens they tend to take more ownership and pride in what they are doing.
Sales people also are going to see their jobs redefined. Physicians want to talk to peers about new medications and clinical studies not programmed robots. I believe that more detailing will be done online and the sales persons role will evolve to a Regional Medical Coordinator. This person will have a medical background and act as a facilitator for the brand among the medical community bring together successful treatment guidelines so others can share what has worked and was has not. Imagine a meeting sponsored by a branded prescription product in which physicians do all the talking about how patients have responded to treatment and what to look for while patients are undergoing therapy. The brand can act as a conduit to share information within the medical community and thus work with the brand team to address issues which may impact the product.
Sometimes for change to work effectively it has to be evolutionary rather than revolutionary. However that evolution can't take too long as the environment in which we work is changing too quickly. It takes vision but the right leader can make it happen so that pharma can do what we intended it to do..allow patients to lead a better quality of life.
In the near future a lot of blockbuster medications are going to be coming off patent and lower cost generics will be readily available. Pharma companies can chose to conduct clinical studies that show new products are more effective than the older generics but benefit and program managers are under increased pressure to control costs. Why prescribe Cymbalta for depression when generic Fluoxitine may do just as well? Want to use Celebrex? Well according to a letter I received from my insurance company store brand Ibuprofen works just as well and costs up to 80% less.
With so many blockbuster medications coming off patent I am sure that more and more insurers are going to recommend that patients be prescribed the generic medications by their physicians. In some HMO's physicians have to write generic medications or go through a lengthy exception process for branded medications. As baby boomers get older they are going to strain a healthcare system already in trouble. Pharma cannot continue to ignore this reality and has to adjust the way they do business. Promotional and DTC spending are all likely targets for cuts and Pfizer's announcement that they are laying off 10,000 people may only be the start of consolidation within the pharmaceutical industry.
The Possible Future of Pharma Marketing & Sales?
Most brand teams within pharmaceutical companies are bloated with people. If you look at consumer packaged companies there usually is one product manager who is assisted by cross functional teams within the company. It's time for pharma to take a serious look at this model and determine if it can work with healthcare marketing. Physicians don't have time to meet with drug company representatives who have become high priced delivery people for samples and chatchkeys. Younger physicians entering proactive are well aware of the benefits of technology to stay on top of new trends and reduce costs within their office. eDetailing continued to grow every year and physicians now want to be able to interact using consumer generated media.
The bottom line is that change is coming to the pharmaceutical industry. As Mr Kindler, the new CEO of Pfizer said this week;
Mr. Kindler made clear that he aims to slash bureaucracy inside the world's largest drug maker by sales. But he acknowledged that he faces a daunting task. "Change on this scale is not easy," said Mr. Kindler. "It takes time to get it right."
It won't be easy but this is what separated leaders from followers. The challenge will be to ensure that these cuts don't effect the organizations ability to compete in a changing marketplace. This, after all, is why CEO's get the big packages. Let's hope they succeed this time and have the vision to ride out the storm.
DTC marketing is not an easy career field to learn and excel in. Often we report to people who have no consumer marketing background and don't understand that marketing is an investment in the brand. However what has made DTC even more challenging is the revolution of empowered consumers. Consumer generated media is at the growth stage of its life cycle and everyone who has a PC can talk about your brand and, more importantly, share the brand experience with others. One disgruntled customer can reach hundreds and thousands with a BLOG or a post on a message board. Yet we continue to read that DTC marketing people are continuing to allocate more and more money to TV while doing the bare minimum for the Web and engaging people in dialogue. Product websites are often stagnant with content that is rarely updated. Before implementing any programs months of market research is needed because marketers want to cover their ass and don't know all they should about their customers.
While working in DTC I have seen good people who made a difference in patients lives passed over for promotion while others who were in the right place at the right time get promoted. Sure these people maybe competent at what they do but when I build a team I want people with a passion for what they do not people who "fit a certain profile". How would you feel when an intern comes back to work for your company, after getting her MBA, and gets promoted within a year while over the past 4 years you, and a lot of people like you, have won awards for your work and made a difference in patients lives? Can you say "work on my resume, I'm outa here!"
Those of you who read my posts here know that I am extremely passionate about DTC marketing and the Internet. DTC, when it's done right can help patients take a more active role in their healthcare choices. What continues to frustrate me however is that with all the great work I, and others, have done those who control DTC dollars continue to look at TV as the "golden egg" to reach consumers and patients. I once presented data that showed that over 85% of website visitors to my product.com website came from online media and search yet the next year my budget was cut in favor of TV even though an online survey of test and control groups indicated a 20% lift in intent to ask their HCP for my product vs. those that had not read content on my website. These are the kind of things that drive people crazy and out of DTC marketing. There are too many old school marketers in the field and to be blunt..it shows.
George W. Merck said: "We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear"
Is this still true today? The answer to that is more no than yes and that is unfortunate. Because of litigation, lack of leadership at the CEO level and the power of Wall Street the pharma model today has evolved more into a business/proift model than a "medicine is for people" model.
The recent news that Genentech's profits soured 76% in the fourth quarter was hardly enough to impress the "what have you done for me today" crowd on the Street. Their stock did go up but then quickly corrected after analysts projected slow growth ahead. News like this is what CEO's are graded on, not the number of new drugs that can save or enhance patient lives.
Having a best in class drug no longer means success for pharma. Lilly's Zyprexa for example has helped millions of people live better lives but because of the weight gain issue Lilly has to pay out over a billion dollars to settle litigation. That's a billion dollars that will primarily go to lawyers..that's a billion dollars less that can be spent on new breakthrough products. It also means that some drugs in development won't get the funding needed to advance to next stage clinical trials because of cuts in funding.
While some CEO's retire with $83 million pay packages (hello Pfizer!) others come under intense pressure to please the people on Wall Street who grade their performance. Do you think that these people care about patients? They only care about one thing.....profits and long term financial outlook. Why do you think most CEO's have a financial background ?
With the costs of introducing new drugs increasing and pharma spending less time looking at new ways to reach patients and consumers the model is broken. Where have the industry leaders like George Merck gone? Almost overnight they have become accountants and forgot that the real reason we are here is to make a difference in patients lives but it is naive to think that good medicine will lead to profits in today's regulatory and cost environment...that is until someone steps forward and shows the industry how it can be done.
So are pharmaceutical companies public corporations who have a responsibility to shareholders and investors or not? Do they have a right to make profits and a return on investment ? The Times would have you believe that big pharma is evil and must yield control to the government because we can't trust them to do the right thing.It is time for the Medicare drug program to work harder for its beneficiaries without worrying so much about the pharmaceutical companies
There a millions of people who have a better quality of life thanks to prescription drugs. We can now control our cholesterol with statins; a diagnosis of AIDS or cancer no longer means a death sentence; and people with arthritis can still stay active all because, in part, to prescription medications. The Times however would have you believe that big pharma is interested in profits at the expense of patient safety. The recent series of articles on Lilly's Zyprexa was shortsighted and poorly researched. I can understand Lilly's settlement with more Zyprexa cases but for the life of me I don't understand why they allow the media to kick them around. It is a disservice to the people who work in the industry and to the millions of patients who continue to lead better lives because of Lilly products.
As a law student I learned that cases are based upon facts and only facts. To my knowledge there is no evidence that Vioxx causes heart disease yet in some litigation against Merck the plaintiff has won their case. Why? Because we want to blame someone and it's so easy to demonize the pharmaceutical companies and put them in the cross-hairs. Someone died and we want to be able to assign blame, right or wrong.
The Times definitely has an axe to grind with big pharma. Some senior editor or owner evidentially wants to socialize medicine so that pharma has less and less to allocate to R&D. They don't understand that it costs upwards of $700 million to get a drug to market and that only one of 7 products actually makes it to market. I hope the American public is smarter than the Times would have us believe. I hope that they can ask the questions which I have raised here today...if they can't than the American pharmaceutical industry as we know it today could be a thing of the past with fewer breakthrough products. Pharma needs a DTC program of its own to tell its side of the story..it's long overdue.
I used to shake my head at the pharma reps who came into HQ's for their training. Most looked like they were right out of school and they were taught to detail physicians using a script to the letter. The guys were all young and the women all tended to be very good looking (not by accident). If I were a physician, I often wondered, would I listen to these people to get my free my sample? Unless you have some new information on your product I probably wouldn't want to hear it. Yet big pharma continues to spend millions of dollars on sales people salaries, expenses, and travel. Sure some pharma companies have cut the number of sales people but there are still way to many out there.
What would happen if, in order to get samples, physicians would have to complete a detail online or via a CD-ROM( when THEY have time)? What would happen if pharma companies hired regional physicians to talk with physicians peer to peer via in person, online, or by phone? What if pharma companies could distribute the results of ongoing or new clinical trials to physicians without putting a spin on it? Could one company possibly handle samples for a number of pharma companies via mail thus reducing the need for pharma sales people to be expensive delivery people? These are things that pharma companies should be exploring NOW because the environment in which they compete is going to get worse and more competitive. They can't continue to funnel millions of dollars into a sales force that is becoming less effective.
There are some products that will require some type of sales force to keep HCP's abreast of changes in the market, most notably the sales people who sell speciality products like oncology products. But do we really need sales people to detail HCP's on Cialis, Viagra, Allegra, and other me too products? I am not sure what the direction or the answer is but pharma had better start testing a lot of programs to see what works and what doesn't because the people on Wall Street won't be kind when earnings decline and expenses continue to climb.
Since the NY Times does a great job of kicking big pharma around I thought that I would share with you some of my experiences during my five years at Eli Lilly at Indianapolis. I was primarily in the eMarketing area and worked on several brands including Prozac, Sarafem & Cialis. I learned a lot during my five years and although I am not an ideologist I would have left Lilly sooner if I thought there was any truth to claims that Lilly pushed "off-label promotion of ANY product.
While employed at Lilly we were required to take quarterly compliance training. During this class we were given instruction by our legal, medical and regulatory people on what we could do and, more importantly, could not do. Each employee, including Directors, then had to take a test to ensure that they understood the course materials. In addition there was a book of ethics that Lilly maintained called the Lilly Red Book. Again we were required to read this book and take a test to ensure that we understood the materials.
When preparing marketing materials we were required to go through a MLR review (medical, legal and regulatory). I can tell you first hand that this team tended to be very conservative in both DTC and DTP materials. If it didn't say it on the label then we didn't say it to physicians or consumers, end of discussion. I can't tell you how many times we argued with the MLR team but their word was final as they were the ones who had to sign off on all materials. As a marketer I often shared with them insights that we had learned during consumer or physician research so they had a better understanding of why we were proposing certain tactics. This led to a better session and after working with my MLR team I gained their trust but they continued to scrutinize every marketing message.
During my time with Lilly one thing always seemed to guide me. The Director of Marketing Services told us in a group meeting once that we should do everything just as if a patient, or consumer, were sitting right by our side. Lilly's slogan is "answers that matter" and in everything I observed and did we always tried to provide patients with the answers to questions on our products. In the rare occasion when a brand team received a letter from the FDA the MLR team would immediately go into action to amend or suspend the materials in question. Management told us, in so many words, that a letter from the FDA was unacceptable and that "it won't happen again". (translation if it does there is going to be hell to pay)
I was proud to be a Lilly marketer and I am still very proud to list Lilly on my resume. A company is only as good as the people it hires and retains. Yes, there might have been some mistakes made by some people in the past but for the most part they were shown the exit. Because of my time at Lilly I am a better marketer and while there I was able to convince some senior people that the Internet was a great channel for communicating with our audience and that the Web was about users, not about pushing information to visitors.
I read the NY Times everyday and for the most part I consider it a good newspaper. They have had some major blunders of their own in recent time but I won't hold that against them. I am extremely disappointed at the recent set of articles that ran in the Times on Zyprexa however. It was old information and the Times never seemed to question the motives of the lawyer who released the information. That's ashame because there are a hell of a lot of good people at Lilly who deserve better and who are trying to make a difference in patients lives..and that is what it is all about.
If you had a chance to read my BLOG last week then you are well aware of the NY Times articles targeting Lilly's marketing practice for off label use of Zyprexa. Forget that this was leaked by an attorney who is in litigation with Lilly and has a vested interest in releasing this information what really strikes me, once again, is the lack of research by the NY Times and the reporter who wrote the articles. Two medical journals have stated that off label use is common among practicing physicians.
According to an article in August of 2006, the Annals of Internal Medicine stated the following:
Off-label use is the common practice of prescribing a drug for an indication other than those approved by the FDA. The physician rationale for prescribing off-label is often based on the lack of FDA-approved effective treatments, reports of clinical effectiveness for the off-label use, or both. A recent study confirms that off-label prescribing continues in earnest, with 21% of drugs listed in a data set being prescribed for off-label uses, most with little scientific evidence of efficacy. Although the responsibility for seeking FDA approval for adding new uses to the product label resides solely with the manufacturer, companies are reluctant to invest the resources necessary to develop the evidence required for FDA review, particularly when the off-label uses are already profitable.
In addition another article in the Archives of Internal Medicine in May of this year found:
Off-label medication use is common in outpatient care, and most occurs without scientific support.
So what does this mean? It means that physicians are doing what they feel is in the best interests of their patients. They don't have a lot of confidence in the FDA or pharmaceutical representatives to give them the information they need to make decisions based upon what is best for patients. Pharma companies, for the most part, do not promote off label use of their products and anyone who engages in such behavior is subject to immediate termination. It also means that once again a reporter did not present a balanced news story that was researched in depth.
Next time I read a story like this I am going to check my drivers license to ensure that I was not born yesterday...
It seems that the New York Times is on a crusade against Lilly. Again, in today's Business section is another article on Zyprexa and the data that Lilly had collected in early clinical trials relating to weight gain in patients. Once again this is from internal correspondence released by a lawyer in Alaska is who currently is in litigation with Lilly over Zyprexa. It's time for Lilly to stop hiding their head in the sand and come up with an action plan to counteract all this negative publicity on a drug that helps millions of people.
Here is an action plan that I would put in place if I were in Lilly's shoes:
1. Invite the reporter who wrote these articles, along with his editor, to Indianapolis for a meeting. At this meeting I would address each "allegation" one-on-one with open honest responses. For example, Lilly might to point out that some people from the Zyprexa team were terminated for actions that Lilly felt "were not keeping in traditions with our compliance policy".
2. I would then invite the reporter to one of Lilly's compliance training programs which are held quarterly.
3. I would then ask the reporter to interview some family members of patients who are currently on Zyprexa so that they can asses the impact this medication has had on a patients quality of life.
4. Finally; I would let the reporter meet with current members of the Zyprexa team and interview them one on one if necessary.
Are these risky? Yes they might be but in this age of media spotlights and 24/7 information Lilly can't afford to hide behind statements like "no comment" and "we don't comment on pending litigation". That went out the door when the attorney in Alaska released this confidential information. Unless America's pharmaceutical companies take the offensive once in a while they are going to continue to get kicked around like an old shoe. Time for the industry to speak up and talk about all the positive things we do.
I guess the NY Times has a bone to pick with Lilly and the pharmaceutical industry. Again Lilly was featured in a front page story about Zyprexa. This time it reported on Lilly's attempts to promote Zyprexa with for off label use. I was not on the Zyprexa team at the time but what the Times failed to report is that the people who were responsible for this poor judgement are no no longer with Lilly. They were shown the door a long time ago and, now it seems, for good reason.
I really don't understand how a national newspaper as respected as the NY Times could be so one-sided in reporting a story. The information that they are reporting was again given to them by a attorney in Alaska who is no doubt trying to cash in by forcing Lilly into a settlement. Lilly already settled most of the lawsuits with a $700 million payment but there are still some lawyers who want their big payday from the pharmaceutical company based in Indiana. What these legal people don't understand is that Zyprexa may have helped millions of mentally ill people lead better lives. It may have eased the burden on society for some people that otherwise might have to be institutionalized. These so called legal people reach out to patients but it is they who will reap the majority of the rewards not patients.
If the reporting in the Times is accurate than in fact several people did use extremely bad judgement in the marketing of the product. A lot of the Zyprexa team people were shown the door and Lilly cleaned house in the brand team a while back. I don't know where theses marketers wound up but I can assure you being fired from a pharmaceutical company is not something you want on your resume.
There are always two sides to every story and instead of the Times sitting down with Lilly with the documents they had in their possession the Times chose to run this story on the front page. So much for balanced reporting. They did contact Lilly and asked them to "comment" but what's the use when you know the outcome is going to be negative. I have a relative who is on Zyprexa and he is doing very well and working full time because of this medication. That is a blessing to family members because the stress of caring for him has affected their well being as well. He has not gained weight and has not had issues with his A1C but you won't hear about that you'll only hear about the people who gained weight and may have become diabetic as a result.
The media reporting in this country has really gone down hill. They seek headlines rather than fact....they don't research stories and the news is more about sensationalism than facts. That's a shame because as a former Lilly employee I was always were told to put patients first and I observed this in the development of a lot of our marketing materials. Like one Director of Lilly taught me "always work like patients are looking over your shoulder". There are a lot of good people at Eli Lilly and they deserve a better more balanced story than the one running in the Times. It's a shame that one of the best newspapers in the world has had to stoop this type of journalism but then again it's about selling papers isn't it?
* I should note that the author of this BLOG used to be an employee of Eli Lilly & Company
This is a week when a lot of people in the pharma industry take vacations but I have a feeling that there will be a lot of important meetings at Lilly's headquarters in Indianapolis this week. As if Lilly, and the whole phrama industry, didn't have enough problems the front page of todays New York Times has an article on Lilly's alleged attempts to play down the risks of its top selling drug Zyprexa. These allegations came from documents — which include e-mail, marketing material, sales projections and scientific reports — and they are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. Is this really new news or is it a well timed leak from an attorney who still is in litigation with Lilly on Zyprexa and wants to put more pressure on the Indianapolis pharmaceutical company?
According to the article in todays Times;
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.
A couple of things about this story seem fishy to me. First, The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues. Second, the release of these documents maybe illegal given the pending litigation of continued Zyprexa lawsuits. This, to me, seems like a well placed story by a savvy attorney who wants to pressure Lilly into a settlement that will, in all likelihood, support a win and of course monetary collection of fees.
As I see it there are a couple of issues here:
1. Did Lilly try and hide Zyprexa's side effects (weight gain) from health care professionals because they didn't want to hurt sales ?
2. Are health care professionals responsible to monitor patients for possible side effects when they start them on new medications?
This author worked for lilly for almost 5 years and during that time, as an employee, I was required to attend quarterly compliance training to ensure that I was aware of marketing compliance guidelines for both health care professionals and patients. I believe that these documents are being taken out of context. Zyprexa may have helped thousands of mentally ill patients lead better lives and be more productive to society. In addition isn't it the obligation of a prescribing physician to monitor patients while they are on prescription medications? The biggest pharmaceutical product in the world, Lipitor, for example requires that physicians monitor patients while on the medication to ensure that liver damage does not occur.
If anything maybe Lilly should have included a stronger warning to health care professionals about the weight gain issue and to monitor patients weight while on the compound. I just don't believe that in an age where every marketing message is archived that Lilly would have tried to hide anything or risk patients health for sales dollars.
Of course decisions like these are made ordinary business and medical people and sometimes they can chose the wrong path despite the efforts to keep patients best interests at heart.
Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says. DUH ! With direct to consumer advertising over $4 billion and increasing and a small staff of reviewers just what is the FDA supposed to do?
From 2002 through 2005, it took the Food and Drug Administration four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules, government auditors said. Between 1997 and 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.
The Government Accountability Office also said the FDA lacks an effective way to screen, review and track the more than 10,000 ads and Web sites brought to the agency's attention each year. The amount has doubled in four years.
The Health and Human Services Department, the FDA's parent agency, acknowledges that the FDA's six reviewers can't scrutinize everything so they focus on those ads with the greatest potential to affect public health. The department said the lengthy legal reviews give the FDA more teeth because the letters that are sent rest on a more solid legal foundation. "As a result, companies take our letters more seriously and quickly react to the problems identified therein," the department said in written comments to the GAO, the investigative arm of Congress.
Will this lead to more reviewers? Probably not but you can be sure that when Democrats take control of both houses that this report will be used against the FDA. The new head of the FDA is sure to be called in front of Congress to explain the the FDA's lack of oversight of DTC ads and websites. Changes are in store but for now the direction and scope of those changes are anybody's guess.
There is a good analysis of the strengths and weaknesses of Lilly's potential long term strategy in today's Wall Street Journal. Zyprexa, Lilly's biggest product, is coming off patent in 2011 and Lilly is looking to its pipeline to replace lost Zyprexa sales. Will this strategy work? That's a good question but this author believes that Lilly maybe aware that the days of blockbuster drugs are coming to an end.
Cymbalta has had a tough time achieving the blockbuster sales status of Prozac. It seems, in order to cut costs, research is being circulated that shows that Cymbalta may not be any better at treating depression than of Fluoxetine ( generic Prozac) which is a lot less expensive. Zyprexa is also under attack with similar research studies and it's feasible to think this trend will continue as insurers look to cut the costs of prescription drugs. When I was prescribes Celebrex, for example, for my shoulder my health provider sent me a letter stating that OTV Ibuprofen was just as effective as Celebrex and a lot less expensive.
The new drugs in Lilly's pipeline do look
promising but as Pfizer learned the hard way there
is always some risk in the development of new
drugs.
One of the new drugs in development at
Lilly is
Prasugrel, a blood thinner which Lilly hopes can
rival popular Plavix. This product does have risks
and let's hope that Lilly is not too dependent on
the success of Prasugre. According to today's WSJ:
The drug appears to create a greater risk than Plavix of causing bleeding in patients, a potential side effect since blood thinners inhibit clotting. The drug faces greater scrutiny and a tougher environment for clinical trials in light of recent disappointments from Nuvelo and Bayer AG, whose jointly developed blood thinner failed to meet targets in late-stage tests, and Pfizer's decision to stop developing the good-cholesterol drug torcetrapib. Lilly also will have to split prasugrel profits with Japanese partner Daiichi Sankyo, making the drug even "less of a long-term earnings driver for Lilly.
The analysis of the Lilly in today's WSJ is good but it's not a thorough analysis which is what I have come to expect from newspapers. In addition to the drugs in the pipeline you also need to take a look at the people who will market these products. Lilly has never been known as a marketing powerhouse and they are going to need marketers with a lot of skill to market products in this era of increases scrutiny and consumer power. One thing is for sure there is a lot of uncertainty at Lilly and in the whole pharmaceutical industry. Lilly will survive and may even prosper but they may have hit a ceiling in overall sales growth. For a while they may just be a $10-$12 billion profitable pharma company with a diversified portfolio and that is fine in the new economy where blockbusters may be few and far between.