Provenge Dealt Another Blow

Provenge and the men affected by prostate cancer were dealt another blow when advocacy group Care to Live had several of claims against the FDA dismissed. The case is still progressing, although in much more abbreviated form.

The judge’s primary argument is that Care To Live can’t really sue the FDA since the FDA hasn’t actually made a decision. Although I would argue that rejecting the scientific evidence and the recommendation of its own advisory committee is tantamount to the FDA making a decision. I have to take exception to the judge’s position because Act Up once sued the FDA for dragging its feet and was ultimately successful in getting the agency to get moving. No reason why that shouldn’t happen here.

That stench is not post-Thanksgiving, turkey-induced flatulence. Something stinks with the way this whole Provenge situation has been handled. There will be other lawsuits and they will be successful. It may not be this lawsuit against the FDA, but there will be others…targeting both the FDA and the inappropriate actions of the advisory committee members.

Hat tip: Pharmalot

Happy Thanksgiving

Happy Thanksgiving to all!

GSK Buys Reliant

GSK just announced that it will by Reliant Pharmaceuticals for $1.65 billion. The deal was essentially for Lovaza (omega-3-acid ethyl esters), a treatment for high triglycerides.

Commenting on the acquisition agreement, Chris Viehbacher, President, US Pharmaceuticals, GSK, said, “The addition of Lovaza to the GSK portfolio adds a new driver of sales growth in the USbusiness. It represents a strong strategic fit, complementing Coreg CR®, a leading treatment for heart failure and hypertension, and adds to our growing profile in the cardiovascular disease area.” [Yes, that is a typo in the GSK press release.]

It’s an interesting move. Every pharma company is trying to move away from primary-care products into the more lucrative oncology and biotech drugs, and here’s GSK moving more into cardiovascular.

It’s an odd move, but not necessarily a bad one. It will be interesting to see how this shakes out.

Mixed News for the Cox-2 Class

Novartis Prexige was dealt yet another blow today when European regulators initiated a review of the drug’s risk vs. benefit profile. Sales of the drug were suspended in both UK and Germany. So far this year, Prexige was yanked from shelves in Australia and Canada, and the U.S. FDA declined to approve (see Prexige DOA).

Pfizer won a victory on patient lawsuits on its Cox-2 Celebrex. The judge in the case said that the plaintiffs attorneys have failed to present sufficient scientific evidence demonstrating a causal link between Celebrex and adverse cardiovascular at the standard daily dosage.

Doctor Ratings Business Gets Boost

There is a growing movement to rate doctors’ performance. (See my previous coverage in Ranking Your Doctor)

Recently, Wellpoint announced it would partner with Zagat (publisher of restaurant ratings) to rate doctors. And last week, Aetna announced a deal with New York State to evaluate physician performance.

Many physicians (particularly the good ones) welcome the transparency and don’t need to hide. Unfortunately, not all doctors feel this way.

Physician ratings will only increase as the healthcare system becomes more transparent. And this will only serve to benefit patients.

If Tylenol Happened Today

The recent lawsuit by J&J against the American Red Cross has brought J&J’s communications strategy to the forefront of the debate.

The pharmaceutical industry has changed substantially since the Tylenol tampering incident of 1982. J&J was lauded for its response – open communication, transparency and decisively pulling the product in the interest of patient safety.

Since then, J&J has had problematic product withdrawals of Confide in 1997 (a home HIV test) and another Tylenol problem in 2005. And, by the way, there were the withdrawals of Propulsid and Duragesic. In each instance, the company was criticized for not acting decisively enough. J&J calls it Slow Cooking – or taking their time. Slow Cooking is fine when you are making soup. When your products are a matter of life and death, you don’t have the luxury of taking your time. Communications can’t be a “by the way” afterthought; they need to be fully integrated into your overall strategy.

If the Tylenol tamping occurred today, we would be looking at a response that would have taken weeks or months, not days.

Other companies in the industry should look at J&J, its lawsuit against the American Red Cross and evaluate how you would do things differently. J&J is in a rough spot trying to protect what it perceives to be its intellectual property (the red cross trademark). I empathize with the no-win situation they are dealing with. But no-win is different from a guarantee-lose situation. Ten years from now, we will look back on this Red Cross lawsuit in the same way we look back at Tylenol and consider this a turning point in the history of Johnson & Johnson.

Zyrtec-D OTC

The FDA approved Johnson & Johnson’s application for non-prescription Zyrtec-D (because of the D, it's not actually OTC - more like the trendy BTC). The product will now compete head-to-head against Claritin-D. Given the consumer marketing muscle of J&J and P&G, this is a ballgame to watch.

By the way, like most J&J announcements, they didn’t announce it – even on their unofficial official unofficial blog. Like most folks we learned about it from the FDA. I know the FDA has a lot on its plate these days, but I would like to thank them for helping out the J&J communications team.

J&J’s Red Cross PR Mess

Christiane Truelove at MedAdNews picked up on my coverage of J&J’s Red Cross mess in her Pharma Blogs recap and made a few good points.

Truelove writes, “But I can’t find a press release on J&J’s Website about the matter, never mind the original complaint or the amended complaint that would have been a nice tool for reporters.” This is EXACTLY what I’ve been talking about. Typically, when companies engage in litigation like this, they actually try to tell their side of the story and set up a section in the press room of their homepage with all the relevant documents. It’s a simple step that adds credibility to their argument (J&J doesn’t seem terribly concerned about credibility in this Red Cross mess). J&J’s argument at the time was “oh gosh, we were on vacation.” The vacation is over, so the only possible explanation I can find is that J&J is just out to lunch.

Not surprisingly, J&J’s official unofficial official response to the Red Cross press release was issued on its unofficial official unofficial blog – JNJBTW. Marc Monseau at JNJBTW is irritated that journalists aren’t picking up on J&J’s arguments, although it’s not exactly clear from his note how journalists are supposed to understand the company’s position when it isn’t actually doing anything. If Monseau wants journalists to pick up J&J’s arguments, maybe J&J could start by making them first. It’s a tall order, I realize, but would go a long way to helping the company. [Incidentally, JNJBTW devoted considerable space last week to whining about what it perceives to be unfair media coverage of the company. Perhaps this might signal.]

Monseau writes on the blog: “I’m all for providing details and information whenever possible, but news organizations should also have a responsibility to get their facts in order - particularly in legal matters where both sides have a story to tell and where there many facets to consider before drawing a conclusion.” To J&J, I say: Stop trying to play victim. You sued the Red Cross – it’s your responsibility to tell your story (which you haven’t done). We’ve all been trying to work with J&J and can’t even get a return e -mail. The Red Cross is doing all the talking and doing a brilliant job of laying out their arguments (kudos to the Red Cross PR Team for, well, doing their jobs). When a company attacks a celebrated non-profit institution, I would argue that the company has a moral and ethical responsibility to explain its actions. That hasn’t happened.

Monseau blames journalists for the biased media coverage, claiming they incorrectly picked up the dismissing of one of eight claims from the Red Cross press release. I would point out that the one-of-eight claims that the judge dismissed strikes at the very heart of its case (the elusive agreement that the Red Cross, who began using the symbol first, supposedly gave all commercial rights to J&J). Monseau is correct, in terms of mathematical quantity, seven-of-eight claims remain intact (although not the most important one). It’s like having a patient in a persistent vegetative state – the rest of the body is intact, but if the brain is gone, there's not much hope left.

J&J’s tonic for this situation is to tell the media to slow down – Slow Cooking they call it. Several years ago when I first met a prominent reporter at the Wall Street Journal, he was all hot-under-the-collar about J&J’s unresponsiveness. On the day we lunched at the Princeton/Columbia Club in New York, he joked that Pfizer would never leave him alone and J&J would never give him the time of day. The joke was that women conceive and birth children faster than J&J can get back to you with a request for a media interview. At the time, I thought he was blowing smoke. I’ve got a different perspective now. It looks like J&J adopted the Slow Cooking model a long time ago.

One has to wonder, if the Tylenol disaster struck today, would J&J employ the Slow Cooking communications strategy? We would probably be looking at a much different response from the company. But more on that later this week.

Merck Settles Vioxx Lawsuits

Merck has flip-flopped on its legal strategy around Vioxx and is now settling a large number of the suits for $4.85 billion. Previously, the company indicated it would fight each and every one of them.

The settlement is a bit complex. Each individual case will still be reviewed and it’s not a class-action settlement. Plaintiffs would still have the burden of proving their case, although just not in a court of law. Interesting strategy.

Red Cross 1, J&J 0

And Round 1 goes to the American Red Cross.

New York Federal Judge Jed Rakoff tossed part of Johnson & Johnson’s ridiculous lawsuit against the Red Cross over using the red cross symbol. The judge dismissed the portion of the suit that claims that the American Red Cross had promised not to engage in the sale of emergency preparedness products. No response or statements via J&J on its website (or blog).

I’m all for protecting one’s intellectual property rights, even when it is not very popular. There’s bold, and then there’s stupid.

Mark W. Everson, president and CEO of the American Red Cross said, “I appreciate the court’s decision and hope that Johnson & Johnson will reassess their actions and drop the case altogether. As the recent wildfires in California demonstrated, the Red Cross has an important mission to perform, and we want to put this distraction behind us and do the work the American people expect us to do.” Noble sentiments. Ironically, both the American Red Cross and Johnson & Johnson are taking responsibility for helping the poor folks devastated by the San Diego wildfires.

So we check the J&J blog where they seem to be doing all of their communication these days. And on the J&J blog, we learn that it is actually Johnson & Johnson helping the people of San Diego. According to J&J’s blog: “Since each disaster is unique, the response to any given situation varies. The one thing that’s always the same, though, is how quickly we try to respond. Around-the-clock phone calls and emails with relief organizations we partner with as well as other Johnson & Johnson employees during and immediately after any disaster strikes are a routine occurrence. These discussions help the team understand the extent of the disaster, the needs of the people affected, and the best way we can help to ensure that the right products and resources get to the victims quickly to save and improve as many lives as possible. Johnson & Johnson has responded to major disasters all over the world for the past 100 years.” You could also substitute the words Red Cross for J&J and come up with the same statement. Is J&J really helping in San Diego or is it an attempt to prop up the credo and maintain a facade of social responsibility?

But here’s where the J&J misses the PR boat (again). Previously in its communications about the lawsuit against the Red Cross, J&J has maintained that it actually supports the Red Cross and provides them with money. In the JNJBTW blog, as they tout their involvement with groups like Direct Relief International and America’s Second Harvest, they could have mentioned their support of the Red Cross (assuming J&J has actually supported the Red Cross in the past). It would have made a lot of sense.

We can’t avert our eyes from J&J’s PR disaster.

For background see:

• Red Cross Sued by J&J?


• J&J’s PR Gaffe Continues


• J&J Flushes Tylenol Goodwill


• How the Mighty Have Fallen: Johnson & Johnson


• J&J Expands Red Cross Lawsuit


• Johnson & Johnson Moves to Profit on Clara Barton Name
  

Anti-pharma Groups Criticize FDA Study of Prescription Drugs

A coalition of consumer groups have issued a statement condemning the FDA’s study of prescription drugs. The statement was issued by Prescription Access Litigation (PAL), Community Catalyst and ragtag coalition of anti-pharma groups.

Their main objection is that the FDA hasn’t issued enough warning letters to pharmaceutical companies. The comments are long on assumptions and seriously short on facts (did you expect anything else?). Here’s the short version—the entire basis for PAL’s comment rests on the notion there needs to be more FDA actions on drug ads. Yet nowhere in their rambling comments do they provide any justification for this opinion.

They state: “The obvious conclusion is that while prescription drug advertisements have flourished, regulation and enforcement of the rules regarding such ads has all but disappeared.” They are unable to cite even a single DTC advertisement that should have received a warning letter, but didn’t. And from their press release they “called for the U.S. Food & Drug Administration (FDA) to increase its enforcement against deceptive Direct-to-Consumer Advertisements (DTCA) of prescription drugs.” In their entire complaint, how many “deceptive” ads did they name? Lucky guess. Again, long on assumptions and seriously short on facts.

Here’s a contrarian view – FDA enforcement actions against DTC ads are at an all-time low because drug companies are complying with the rules.

PAL’s an interesting group. They are anti-consumer and last year condemned Rx-to-OTC switches. Why? They claim it is a vast conspiracy funded by pharmaceutical companies to over-medicate Americans. I have a different take. The groups that are members of the PAL coalition enjoy a very comfortable relationship with organized medicine. Physician groups have long opposed Rx-to-OTC switches because it reduces their profit.