How's this for responsible? In March, Pfizer happily announces in a
press release that a study of 80,000 managed-care patients found Lipitor lowered the risk of cardiovascular events by 14 percent compared with Zocor. The drugmaker, which adjusted for dosages, called this "significant." And the study author, University of Maryland's Bob Vogel, intoned that "this analysis is important for physicians, employers and formulary directors at managed care companies..." In other words, people who may reach instead for generic Zocor, which threatens Lipitor.
Today, however, Pfizer files a sheepish, two-paragraph statement with the SEC, because there was a problem with the study. "A subsequent review" found that risk was lowered by just 10 percent, "which is not a statistically significant difference." Pharmalot chatted with Pfizer spokeswoman Vanessa Aristide, who says the mistake was due to a "programming error†that was discovered after the study was submitted for publication. But where's the press release to alert the physicians, employers and formulary directors? There won't be one.
"It was just a corporate decision. We're going to seek publication of the new info with the necessary corrections and it was decided that it was appropriate to update the SEC," she says. "We are taking corrective measures."
Okay, mistakes happen. Let's take that at face value. But if it's okay to tout good news, why is it so hard to acknowledge the mistake in the same way? It's just as easy to hit the send button for a press release as it is to file with the SEC. Weeks or months could go by until the same people who heard of the Lipitor results last March - thanks, in part, to the press release - may hear of the corrected data. That's potentially unfair to patients, who Pfizer claims to want to help.
Hat tip to the Health Blog
19 Comments
[...] both Pharmalot and the Wall Street Journal Health Blog are posts about how Pfizer Inc., the world’s largest [...]
Why doesn't the American public like Big Pharma? Why don't they trust them? Why is every new report met with raised eyebrows about not only how the study was conducted, but how the "numbers" were spun? Why are we angry about constant bombardment with DTC ads? Why do we now view our doctors with suspicion--does he really care about me, or is he getting a pharma phavor? Why? Why? Why?
I think the lesson is clear (one I've been not unseriously asserting for a while now): the SEC - not the FDA - mandates a higher duty of disclosure from Pharma than the FDA or the medical profession.
Until doctors or the FDA start to demand the same, you might as well go to the SEC if you want the unspun truth.
Commercial "free speech" may let you peddle half-truths and un-truths to gullible doctors and patients . . . but you can't do the same to investors.
Morris, that is SO true.
Pfizer has data that are relevant to the choice of a therapeutic agent for a common disease state.
Choosing to give the Street a heads up without notifying others who have inaccurate information (on Pfizer letterhead) is simply arrogant.
It is becoming difficult to defend an industry where major players are aware of the truth in the data but refuse to be accountable to stakeholders beyond the financial community.
Pfizer CEO Jeff Kindler has said that he considers himself accountable to investors and they are his primary concern as he is rewarded on increase in share price.
Pharma company CEOs ARE accountable to investors not just because of their individual rewards but for the overall performance of thie business, because that's ewhat they run - businesses. They are also accountable for their employees, their research and development, and for making sure that the patients who ultimately receive their medicines are given, directly and through healthcare professionals, access to accurate infomration about their condition and the drugs they are taking. But once a drug is launched responsibility shifts from being exclsuively that of the pharma company to a shared one between them, the providers of medicine, and the patients and their families to track, report, analyse and react to changes, news and reactions. Remember there are millions of patients using these drugs. It is difficult to think of any business that can track individual users' responses to their products and react immediately to problems. If the wheel falls off your Volvo it's pretty apparent there is a problem. If your husband develops a symptom it's difficult sometimes to relate it to the medicine he's taking or to distinguish it from the condition itself. Once notified companies are responsible for, and in 99% of cases, do react quickly and appropriately. But it is a shared responsibility once the medicine is in the public domain. Most pharmaceutical companies, in my experience, are led by responsible and reasonable people who thororughly understand the ethical responsibilities of the business they are in, and ensure that their staff acst appropriately. But it is a business and in order to continue successfully researching and developing treatments for patients, businesses have to be profitable and run accordingly.
The purpose of filing a Form 8-K is not to "update the SEC," but to update the company's shareholders about a material event. Pfizer may also have been worried about potential lawsuits if the eventual publication of the study caused its stock price to drop. By filing the 8-K it eliminates any potential liability to investors who purchase its stock between the time the 8-K was filed and the time of publication.
Hi Marilyn,
Thanks for stopping by. And yes, the purpose of the 8K is to update shareholders. I used shorthand to describe what you referred to more specifically. Sorry, though, for not being precise.
In any event, I'm not sure if this was clear, but I never suggested the company shouldn't file an 8K for the reason you and Chris indicated.
I believe I already made my own point, which is the company has a responsibility to disseminate the information to the same audience targeted with the original press release - and to do so in a manner that would most effectively communicate that info. A press release would accomplish that.
And by doing so, more docs would be able to share in the responsibility of tracking patient reactions and the like to the drug. If this 8K filing hadn't been publicized - and all this chatter is still no substitute for a press release - then docs would be at a disadvantage until the corrected data is published. And when that would be isn't clear.
Regards to everyone,
ed
Ed,
I totally agree with you that they should have issued a press release.
Melody, it's not that people don't like big pharma (although some don't) but rather that we are wary of them.
There are some great people working for Big Pharma, but not all of them are concerned with the patient, unless it directly relates to business P & L.
I've worked with plenty of people in the industry that have probably forgotten that it the whole point is to sell EFFECTIVE products to patients who need them, rather than just selling widgets like any other manufacturer.
DTC ads are a problem, in my view, because the average US citizen isn't as smart as everyone makes ourselves out to be.
Sure, there are plenty of us who are intelligent, but do you really think the average person should be deciding which medication to use based on Advertising??
Granted, back to the original article, it's not as if Big Pharma is the only industry using this type of Shout/Whisper tactic; have you ever noticed how small the corrections section of published materials is? It's not because they are concerned with getting the correct information to their readers......
However, this is my personal health (and everyone else's) that we are discussing here, and Big Pharma should certainly be held to a higher standard than any other industry.
Ok, I give you that pharma wants to put their best face forward. I also give you it is wrong and deserves more oversight and penalties for bad behavior.
I keep hearing how docs will bend over backward to reward big pharma for the $5 sandwich they grabbed while saying hello over a 3 minute lunch. I am in the health care industry and I witnessed something very interesting over the holidays. A specialist (oncology) gave $500 wine baskets to his approx. 50 referring physicians. Now, everyone with any medical background would widely attest that he was not a good physician medically. He was very engaging and pleasant. So even if you got poor care, you didn't know better and he seemed concerned. So you were willing to look past and forgive. No one should ever refer a patient to him and he had a thriving practice, I saw many sad stories come out of his office. So there is influence in all areas of life. Everyone wants to do well and make money - even bad physicians.
If you think that the occasional lunch has more influence than $500 of wine from a specialist than I don't understand it. This is little publicized -- PC physicians are not running out to report it. They feel entitled because they know they make less than specialists and feel entitled to some of what the oncologist's make. Specialists are not the target of the press, they are not the bad guy everyone wants.
So instead of considering who brought your physician lunch when you get a script, think long and hard about the specialist they refer you to and why.
Physician referral networks may be an issue worthy of examination, but Ed's bit about Pfizer - the one that kicked off all these comments - is about the fact that Pfizer chose not to report relevant results to everyone who might be affected by those results.
By now, everyone knows that the distribution lists for positive and less than positive data on a branded statin were quite different.
Seems to me that the guys who aren't "very good physicians" are at least as much in need of outcomes data as the SEC.
Investor-/public-relations people at any company are never big on trumpeting corrections or less-than-positive data, hence the sound of crickets chirping from Pfizer. I agree that Pfizer has a "duty to warn" here given that they distributed this info widely via press release, and their own people were out making sure that their key customers knew about it. They were leveraging this info primarily with their MCO/PBM customers. Since I know my ethical colleagues at Pfizer won't do it, I have personally sent this correction to a number of my own contacts at major MCO/PBMs!
Dr. Remulac - thanks for keeping them honest. My question - do you have an interest in this outcome. Everyone wants to be a good samaritan when it also coincides with what personally helps them. I do the same in my job, just wondering if that is you case as well?
Jason - I have a 20-year professional interest in promoting cardiovascular health and prevention. I currently have no other conflicts of interest to disclose, other than a very minor stock position in one biotech company with a couple of compounds in their very early-stage pipeline dealing with lipid metabolism.
sorry put my name in the message - resend
Enjoyed your comments and your ethics. Since leaving big pharma i have been studying unscientific (and often outright falsehoods) marketing messages in cme programming. I have focused my energy on lipitor and pfizer funded cme and have been very disturbed by my findings at dinner meetings and online “educational programsâ€.
I believe the Alliance trial misanalysis is a related event in so far as its blatant disregard for science and patient centered interests. Dr. Vogel the author is one of the most extreme speakers in conveying biased off label messages in his cme speaches. Any interest in discussing?
[...] the sad yet unsurprising category, Ed at Pharmalot has two reports (1, 2) on Pfizer burying negative data about Lipitor. How would they do such a thing? Well, Pfizer [...]
[...] that Pfizer has been hiding negative data about Lipitor - thanks to CL Pysch (and Ed Silverman at Pharmalot who was on the case first with this story way back on 14 [...]