Lilly CEO To Boston: Pharma Will Be Scared Away
19 CommentsBy Ed Silverman // September 22nd, 2008 // 8:04 am
The ink is barely dry on a new law governing how drugmakers can market to docs, but Lilly’s John Lechleiter isn’t wasting time trying to make lawmakers regret their decision. In remarks to the Associated Industries of Massachusetts Executive Forum, he claims the law will hamper innovation and force companies to reconsider expanding in Massachusetts, The Boston Business Journal reports.
“Life sciences investment will be scared away,” Lechleiter told the crowd at the Westin Waltham. The law, which was passed last month and goes into effect on January 1, has “the potential not only to stifle clinical research in Massachusetts, but also to complicate a key part of market access: the ability to share information.” The same theme appeared in recent ads run by drugmakers and biotechs.
The law does not contain a controversial ban on gifts to docs, but does create an academic detailing program to provide unbiased info to prescribers; requires drugmakers to disclose payments to health care providers valued at $50 or more; directs the state’s Department of Public Health to establish regs on marketing, using the industry’s own code as a minimum standard (which means no branded items). And there will be a $5,000 penalty per violation (here is the bill that passed).
Lechleiter maintained docs need to learn about innovations from drugmakers and they deserved to be compensated by those companies “for their valuable time.” While regulations are still being crafted, he argues the law has the potential to “subject doctors, hospitals and academic institutions to complex financial disclosure requirements about payments for clinical research.”
The possibility of significantly more bureaucracy could significantly hamper the state’s life sciences research engine, Lechleiter continued, threatening the more than 5,600 clinical trials now underway in Massachusetts, according to the paper.
“Such work is the backbone of research and development in biotechnology and pharmaceuticals,” he said. “And it’s about to get a whole lot more difficult in this state, which almost certainly means that less of this important work will take place here in the future.”
Lechleiter says the law will affect where the drugmaker locates its next major facility. Massachusetts is a possible site, although Eli Lilly is looking at different options. Lilly doesn’t have a specific presence in the state, but employs about 175 researchers with various organizations in Massachusetts. Lilly funded nearly $64 million in research/clinical grants in Massachusetts in 2006.
Dan A.
The boy seems a bit concerned and scared for good reason.
Justice in MI
Perhaps someone can explain the logic of this from Lilly’s perspective. Why, precisely, are clinical trials threatened? Genuine question - I don’t follow the argument.
Part of what Ed writes: “Lechleiter maintained docs need to learn about innovations from drugmakers and they deserved to be compensated by those companies “for their valuable time.” ”
If this is truly education, I would think doc would pay the drugmaker rather than the other way around. But that’s a separate question (I think) from above.
harpy
“he argues the law has the potential to “subject doctors, hospitals and academic institutions to complex financial disclosure requirements about payments for clinical research.””
I believe, JiM, Lilly is whining about what regulations the Department of Public Health may have in the works. As far as I can tell it is all hypothetical at this point. One would think with all of the problems Lilly is having over Zyprexa they wouldn’t be so openly vocal against transparency laws. But there I go thinking again.
Marilyn Mann
What a blowhard.
Justice in MI
“complex financial disclosure”
Is that something like keeping track of receipts and/or balancing a checkbook?
Harpy - Thinking has been preempted, so watch yourself. Only FDA has the capacity to think (optimally). Smiling is still permitted so long as there is no suggestion of irony.
Big Pharma Guy
He should spend more time worrying about the countless lawsuits his company faces due to their alledged off-lable claims. These Big pharma companies are getting to be a joke. long known for their bullying tactics on everyone from the federals, the states, academic institutions, docs and their own employees, they strike again. I think the stench from Indy can be smelt in Boston!
Dave
The reason that these companies don’t want to have docs disclose is it will finally put in the public domain the bribery practices that have been going on for decades. It will embarras too many people, particularly in the companies and the major institutions. Not only that, the KOLs will no doubt owe bundles of back taxes. many make hundreds of thousands of dollars from the Big Pharma companies.
Dutch
Fearmongering and bullying, what a classy move by Lechleiter
Dan A.
Pharmaceutical Industry Exposed: Desire for an Ethical Resurrection
If you have been in a doctor’s office, you’ve probably seen them. They are the ones that are unusually well dressed — considering their environment. They also are typically young, healthy, and attractive. And worst of all is that they typically pay absolutely no attention to you, the patient, as you are not their objective. Certainly, they will avoid any conversation with you as the reasons for your visits are in opposition.
They are the drug representatives… the detailers… the pharmaceutical promoters and marketers that could care less, really, about your concerns while you are both sharing the same space at the same time. Yet these reps will possibly take up the valuable time of the very doctor you are suppose to see for a health issue or concern, possibly of a serious nature. So there is actually one thing in common between the rep and the patient in the office: you both want to see the doctor, but for entirely different reasons.
Pharmaceutical marketing tactics have become more transparent to many others over the years, and their methods have been exposed more so than they have in the past. And the public doesn’t like what they hear and read, that is largely valid and authentic. This is why the pharmaceutical industry’s image has been traumatized so much during this time over the past decade or so in particular, and the trauma is deserved, considering what the industry does and has done over the years with deliberate intent and reckless disregard in some cases, by seeming to ignore patient benefits for immediate profits.
Yet there are those who are trying to change things for the better. Because pharmaceutical marketing to both doctors and patients is a troubling public heath issue, as they are a threat to the health of the community, certain advocacy groups such as National Physician’s Alliance and Community Catalyst, among others, are addressing concerns raised by the marketing tactics of the pharma industry, and their passion and ability to organize and work as a team appears obvious. I think very highly of their continued efforts to improve the well-being of others.
In a way, such advocacy groups are in fact treating a disease, if one defines a disease as being harmful or abnormal. Also, such groups are attempting to prevent disease by deterring the etiology of the disease itself. In this case, pharma marketers, yet there are unfortunately quite a few others.
In this article, I address four factors focused on by some advocacy groups and conducted by pharma companies that are trying to be fixed or eliminated by others, and where notable progress has been made:
1. Data mining
Data mining is preventing pharma reps from having prescribing data on the doctors they see on a regular basis. This data, while provided to the reps by the employers, originates with the American Medical Association. This association sells data necessary to identify prescribers and their habits, which is purchased from the AMA by the pharma companies. This arrangement is very lucrative for this association. The data the reps have from this arrangement allows them to analyze the historical prescribing habits of the doctors they are trying to influence to prescribe the drugs they aggressively promote in order to specifically create the most effective message to a particular doctor based in large part on this prescribing data. It has been stated and known that vicious debates have occurred between pharma reps and doctors because of this.
There are those that insist this data is necessary for pharma companies to improve treatment regimens and protocols for the patents the doctor sees, and state the data is useful for educational purposes. This clearly is a fallacy. Advocacy groups and others are trying assertively to have bills passed through the legislature in order to prevent pharma companies from having this data, as it is not fair for the doctors for pharma companies to have such records of thier practicing habits with the prescriptions they write, although the names of thier patients are fortunately not included. In fact, pharma’s reps have no right to possess such data, regardless of the content. Furthermore, pharma reps having this data and what they say to a doctor based on this data removes potentially the objectivity of the doctor and may interfere with the best treatment of the patient, prevents any authentic and credible relationship with the doctor, and it could interfere with the judgment of such a doctor.
2. Disclosure
Also the mainstream media to some degree has microscopically received and reported some level of acknowledgment of the money given out by the pharma industry to anyone who can potentially benefit the profitability of the pharmaceutical industry, such as their lobbying force, yet most of their collaborations, remunerations, inducements, and other forms of gifting to the medical establishment remains overall a mystery to the public and the government to a degree until they get caught by the government for wrongdoing because of these attempts at reciprocity with prescribers in attempt to form symbiotic relationships with them. Intimidation and extortion are possibilities as well. Yet insiders if the pharma industry, who choose not to be deliberately ignorant and dig deep for the truth are an exception with their drive to make others aware.
Whistleblowers have been a big help with revealing and uncovering a large part of such activities, which is a rather courageous and brave thing for them to do, considering what they risk, yet regardless, for the benefit of public health, the public consistently should have a right to know where this money goes from the pharma industry to those who are responsible for restoring their health. So again, legislation and bills are being contemplated that would mandate pharma companies to disclose what they dispense financially and for what reasons. The pharmaceutical industry is the most lucrative industry that exists, so they have the money, yet no one knows where exactly it goes. It is mysterious. And likely, if it ends up that the pharma industry reports their financial output, it will likely be an exercise in creative accounting.
We have a right to know. Of course, the pharma industry is opposed to such obligations with the disclosure issue, yet if it is for patient benefits, this money the pharma industry spends, as the pharma industry has repeatedly stated, the opposition should not exist.
A rather secretive industry… Revelation is quite a threat to the pharma industry, so it seems. Is it cronyism? A unique cult? One can only speculate.
3. Direct-to-consumer (DTC) marketing
Two countries allow this: the US and New Zealand. Here’s the problem: About a third of those who view such ads seek out their doctor and ask for the med, regardless if they need it or not. Likely they will get it. And the ads are unmonitored. If a discrepancy is discovered, it’s after an ad has been broadcasted, usually for a lengthy period of time. It is then that the FDA intervenes. Embellishments with DTC ads are obvious. Exaggerations with the disease states are apparent as well. Elimination of such ads are being considered, and should be eliminated, as it diminishes the role of the doctor, for one reason. The pharma industry believes such ads encourage others to seek treatment. Yet they are unable to determine who needs treatment, and clear definitions of the diseases that they are attempting to promote. Doctors, however are. That’s what all that schooling and training is all about with your health care provider.
4. SafeRx Act
Finally there is the SafeRx Act, being considered by lawmakers now, which aims to have reps certified by the government in order to be employed as pharma reps. Ethics are included in the training. Hopefully, the complexity of diagnosis and treatment will be integrated into the certification process as well. Unfortunately, most reps have little if any medical training. In the US, more value is placed on pharma rep selection based in large part on looks and personality. This, needless to say, can be damaging in this particular industry. Yet the act is still pending on a national level. The pharma industry states that it is a waste of time, and their stance on this issue disappoints me, yet I remain unsurprised.
Bias may exist in this article, as I am an ex big-pharma-rep myself and consider myself a pharma critic at this point, yet the contents of this article are factual and not exaggerated. Yet I still honestly recognize the benefits this industry and all that it has provided to others from a historical perspective of lifesaving drugs as well as other medications that delay the progression of chronic diseases. Their effort is acknowledged. And I applaud their efforts to improve patient health, and wish for a return of such ethics.
Maybe in time the pharma industry will become more pragmatic if the public is more empowered with knowledge. Doctors should not have any interference when it comes to the treatment of their patients. Again, there are others besides pharma that are guilty of this. I suppose the issue is best summed up by Hippocrates, who said,
Whenever a doctor cannot do good, he must be kept from doing harm.
harpy
So, I suppose snickering behind my hand is out.
:)
Justice in MI
Definitely. Under current regulations, a wry grin falls into a gray area. But don’t push it or use both hands.
Reality Bites
Playground bullying grows up! The result is a CEO or other significant top management player at a Big Pharma company!
Nathan
Justice asks: “Why, precisely, are clinical trials threatened?”
That’s a good question because in the MA law (linked in Ed’s article) it states that the provisions being drafted MUST allow for “compensation for the substantial professional or consulting services of a health care practitioner in connection with a genuine research project or a clinical trial.”
It seems to me based on this language that the MA law specifically allows for clinical research to take place.
The interesting thing about this law is that it also declares that the provisions being drafted MUST allow for ” the provision, distribution, dissemination or receipt of peer reviewed academic, scientific or clinical information”. Is this a tacit approval of distribution of literature for off-label uses of medications?
Bob Freeman
A very hollow threat worth of universal derision. I can’t help but wonder what color the sky is in his world.
Meg
Mr. Lechleiter, What kind of schoolyard bully do you think you are? If you, and the other pharmas, had had to play by these rules in 2002, my son would be alive instead of dead from Zyprexa. I have seen copies of the scripts Lilly gave to its drug reps then, the words carefully crafted to steer the conversation away from doctor concerns about weight gain, diabetes, hyperglycemia, and death. I read Lilly’s denials in newspaper articles that finally came out in 2003 (Times, WS Journal).
Bob Freeman wonders what color the sky is in your world. In your world, I truly believe, there is no sky. Only flames.
harpy
I think the “threat” to clinical trials is the disclosure provision - “shall disclose to the department of public health the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in the commonwealth authorized to prescribe, dispense, or purchase prescription drugs or medical devices in the commonwealth.” They don’t want to make public how much they pay.
And your second question, Nathan, is a very good one. It certainly sounds like off-label lit would be included, if peer-reviewed, and that would be huge. But there are also requirements for counter-detailing written into the law. The state has to “develop, implement and promote an evidence-based outreach and education program about the therapeutic and cost-effective utilization of prescription drugs for physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs.” (Section 5) So it could work for or against pharma.
Disgusted
I say “Open up the books and let’s see who has paid who what in the past 5 years!” It will disgust everybody.
Super Rep
In response to Dan A, I am sorry if you have felt ignored by the local reps in your doctors office, but the truth is, our companies and your doctor have advised us NOT to talk to the patients in the waiting room. We are frequently asked questions by patients, such as, “Do you think your drug would be better for me than the one I am taking?”
Never in a million years would I answer that question.
1. I am not a physician.
2. I do not know your history or what other drugs you are on.
I will make pleasant conversation with patients about non medical subjects, but I would never try to market to a patient or diagnose them in the waiting room. If I am asked a medical question, I always say, “That is a discussion you should have with your doctor”
Diverse Nurse
I have had some interaction with drug reps and until I got to know a few, I thought about going that route. Most patients don’t have a clue about the idiotic rules reps have to play by or the pressure put on them by physicians to violate those rules. Some docs (not all or most) feel they are entitled to perks from drug companies.
As far as research goes, the FDA, State Departments of Health and Joint Commission should be looking into the behavior of the research departments of some hospitals and universities - a complete lack of ethics and what a waste of money.
I say take the handcuffs off. The rules instituted by the government only get enforced when someone has a political ax to grind or someone gets sued. Let big pharma market their products any way they want. It’s up to the physician and consumer to make prudent decisions about patient care. Many patients/consumers don’t care about health care until they get sick. Then they think it is like taking their car to Jiffy Lube. Take an active role in your own health care - let the buyer beware!