Pharmalot… Pharmalittle… Evening Round-Up
3 CommentsBy Ed Silverman // January 17th, 2008 // 6:37 pm
And so another busy day has come to an end. We hope you enjoyed it as much as we did. In fact, part of our time was spent devising interesting items for tomorrow. Meanwhile, we came across a few interesting tidbits to hope you while away the evening. Catch you later…
For those interested in how a key opinion leader can help promote a drug, Health Care Renewal is a must read today. There is an instructive post about a campaign to market Johnson & Johnson’s Risperdal for depression through “commercially strategic clinical trials and journal publications that were really infomercials,” the blog writes. To keep it simple, this involved the editor of a medical journal, who was also a KOL for J&J’s Janssen while he co-authored a piece about Risperdal without disclosing the conflict. The study, by the way, cleverly emphasized positive results while overlooking negatives. “The appearance of bias and spin was unmistakable,” Health Care Renewal says. Check it out.
Up next is a primer on the significance of the FDA’s proposal for a stricter rule allowing drugmakers to change labeling on their meds without agency approval. For pharma, this is a welcome step, because product-liability lawsuits regularly charge that a drugmaker failed to do enough to warn consumers about a side effect. Right now, drugmakers have some latitude when it comes to labeling changes. The larger issue, of course, speaks to the battle over preemption, that’s going before the US Supreme Court. To understand it all, at least from the perspective of lawyers who defend big drugmakers, take a look at Drug and Device Law blog (second post from the top).
Dan Vasella is having a rough time. First, he confesses that he takes Lipitor, and not his own Lescol or a Sandoz generic, to make the point that people should take the best med that works. But he winds up becoming a poster boy for Pfizer. This is on top of numerous setbacks with the FDA and a subsequent restructuring involving thousands of job cuts. The upshot is that Dan is taking a 20 percent pay cut, an admission he makes to the WSJ Health Blog. “This is the first year I have missed my objectives, or part of them,†he says. “Normally, I always meet or surpass the expectations.†Yes, but he still has his job.
J&J’s Listerine Gives Local Water Supply A Minty Taste (Lititz Record-Express)
Wyeth Still Bargaining With Pearl River, NY Workers (The Journal-News)
Online Pharmacy Settles Lawsuit Filed By NJ Officials (The Star-Ledger of New Jersey)
More Than 50,000 Sign Up For Vioxx Deal (Associated Press)
Justice in Michigan
Re: consulting the Drug and Device Law Blog, I’d like to underline Ed’s point thaqt whatever one reads there “from the perspective of lawyers who defend big drugmakers.”
That caveat says a great deal. While I am on the opposite side of preemption relative to the DDL guys, I find their blog useful in a number of ways. But one should never forget their allegiance. To assume one would find “unbiased information” there would be the same as asking the McCain camp to give an unbiased perspective on Mitt Rommney’s qualifications.
To their credit, the DDL guys don’t claim otherwise. Their job is to defend drug makers. And so they must deliberately ignore or distort information or arguments that could work against that commitment. They make no pretense to doing otherwise.
A word to the wise.
Hypocrisy rules
Re: Vasella and Novartis’ troubles. I would not pretend that I comletely know what the problem with Novartis is. It is in toruble for sure. Although Vasella takes some responsibility for the current situation, he has not resigned and given a chance to someone who has a fresh outlook and ideas. Just as today’s problems are not entirely his fault so were the successes not entirely his doing either. But as all the celebrity CEO’s he too thinks that the world would not turn without him. It would for sure. In fact the Novartis’ world would most likely turn around much faster and keep turning much better. If for no other reson Vasella and his close team have become so unpopular even hated amongst good deal of Novartis’ employees especially the sales people. This especially in USA. Alex Gorsky is considered the worse in US affiliate’s history. With such leadership there is no way this Co will be turned around given the current product mix and morale.
As for Lipitor, you can’t blame him. Lescol is so weak that most docs consider it like placebo. Did not have to be that way. The drug itself is very good but ubder Vasllla’s leadership at the time at Sandoz this drug was ruined by gross underdosing of the unit of dose (pill). They introduced 20mg and 40mg way below what it would have been necessary. Had they done 40mg and 80 mg the efficacy data would have been so good by now that even Vasella would have taken it instead of lipitor. That single mistake cost Sandoz and new Novartis most likely billions in lost sales.I personally know a person PHD who presented a stron case for higher dose, was ignored and later fired. At the time of Lescol’s introduction statins were selling like hot cakes and Vasella told everyone that we could not go wrong with Lescol. How pathetic from a Euro busniss person of the year few years in a row.
Personally I think he will not last too much longer as CEO even with the reduced salary he is not worth it. Actually never was. But then what celebrity CEO ever is?
Bless The Truth
Novartis’s problems were predictable. It is an organization without ears, consumed by blind self confidence and where rotten oldies bury initiatives and innovations. Employees are afraid to speak up! They are intellectually and morally frozen because of the fear of bully bosses.
But, much more than that. God is delivering justice to Novartis over innocent blood that had been battered. As it was in the days of Moses, when he raised up his hands for the Israelites to cross the red sea, and Egyptians army to be swallowed by false hopes, so it is with Novartis. I like the name “Daniel” for Vasella, but he needs to live like Daniel in the Bible time. He needs to stand for the truth! He needs to respect and fear God to escape Nebuchadnezzar’s type of judgment! The woes of 7 times and 7 times may be in the making for Novartis unless they change and repent!
Examine this data:
Novartis stocks closed at $56.30 Dec. 2006; but closed 54.31 Dec. 31 07 (difference of $-2.18) for the year. With 2.30 billion outstanding stocks, that translates into a loss of over $4.6 billion in market value for the year. But it does not stop their, Novartis just reported 45% fall in net revenue…that is a grade of “F” in performance. In the old British system of education, it was called a “withdrawal grade”…meaning been throwing out of the University! I wonder how huge the bonuses are this year? Unfulfilled dreams! But the woes for 2007 were multiplied into numerous blockbuster drugs recalls for safety reasons, mountain of legal cases, (sexual harassment, whistle blowers, equity class action suits against executives for providing false Tasigna safety information, unimpressive “black-box
label approval of Tasigan which is facing flurries of legal battles, and Galvus trip to the grave yard). These are just a few of Novartis mounting problems crying for a SAVIOR. To me, the “Lord is God of Justice”, declared prophet Isaiah.
May be Novartis could borrow some common sense solution from its competitor…MERCK. When Merck was faced with problems, it faced it head on with courage and sincerity. Some consider its $4.6 billion settlement of Vioxx as stupid. But look at this:
Merck’s stock closed at $42.31 Dec 2006, but closed 58.11 Dec 31 2007 (diff of $15.80)…that is about $33 billion increase in market caps. Which company is smart?
But there is hope. Here is my prescriptions:
Daniel Vasella should give his 2007 $15million to charity and needy ones as a sacrifice for all the vices committed by his subordinates and pray for restoration!
Recognize God as the Author of chemical entities, pharmacognosy, pharmacology, pharmaceutics, and above all all the DNAs of human anatomy.
Appoint Employees mediation teams across all businesses who can sincerely and courageously extract innovations, initiatives and new ideas for solving Novartis’s problems.
Fire all managers, executives, who were responsible directly or indirectly for all Novartis’s pending legal cases. They are bad rotten eggs. And you can’t move forward with these rotten evil ones.
Resolve and settle all pending legal cases without bias and turn a new clean slate. Novartis does not gain anything by fighting legal cases in India, Europe and America. It is bad image for your company and it scares investors, while demoralizing your most valuable assets -EMPLOYEES!
Enforce compliance and codes of conduct that can win and enhance investors’ confidence.
If Daniel cannot do this, may be can be humble enough to turn in his resignation for a new breed! But remember, God is in corporate America, and He is watching the innocent hands that are raised up in daily prayers!