Archive for May 2nd, 2008

Quote Of The Week: Pharma Has A Black Eye

roy-vagelosAt this point, former Merck ceo Roy Vagelos is arguably the elder statesman in the pharma biz, and he’s not shy about voicing some opinions. Sure enough, he shared a few while delivering a keynote speech this week at the annual meeting of the International Society for Medical Publication Professionals, which CNBC’s Mike Huckman dutifully noted in his blog.

“Most drugs are a terrific bargain,” says Vagelos, and he believes that high prices are justified if the drug offers high value. But he went on to say that he has a problem with the $50,000 price tag for a drug that adds four months of life. He didn’t mention which drug, but here’s his point:

“There is a shocking disparity between value and price, and it’s not sustainable. The industry will bring about government price controls which will be devastating for the industry…I don’t care what the cost is, it’s inappropriate. The industry has a black eye. And the market will correct that.”

Vagelos also complains that pharma should be more philanthropic: “When important drugs are introduced companies will have to make arrangements to get them into the developing world.” Why? Besides saving lives, Vagelos believes the gesture will generate goodwill in places that could become lucrative growth markets, Huckman writes. And, Vagelos adds, it would also go a long way toward restoring “credibility.”

Pfizer Strikes Deal Over Celebrex & Bextra Lawsuits

handshakeThe drugmaker reached tentative settlements with some groups of plaintiffs who allege the painkillers caused heart attacks and strokes, The Wall Street Journal reports, citing lawyers at three firms involved in the litigation.

The firms represent more than 200 of the thousands who sued Pfizer over the two meds, but the drugmaker is still holding talks with other law firms, the paper writes. Unlike Merck’s recent settlement of most Vioxx lawsuits in the US, Pfizer is trying to resolve its liability on a firm-by-firm basis, the lawyers tell the Journal.

A Pfizer spokesman call us to say there is no comment. And Michael Rozen, an attorney with the Feinberg Group who is negotiating the deals on behalf of Pfizer, didn’t respond to the paper’s request for comment.

A lawyer at one law firm told the Journal he had been offered about $200,000 per client, on average, to settle his Bextra cases and an average of $40,000 to $50,000 per client to resolve Celebrex suits. Bextra, you may recall, was withdrawn from the market three years ago. Pfizer is willing to pay as much $500 million overall to resolve the litigation, the paper writes, citing unnamed attorneys.

The first Bextra trial was due to go begin Monday in federal court in San Francisco. Beverly Haslam, the plaintiff in that case, claims her husband died from a heart attack that resulted from taking Bextra. But earlier this week, the parties agreed to adjourn the case so Pfizer could attempt to settle Celebrex and Bextra cases across the country, according to a lawyer involved in the Haslam case.

Washington Pharmacists Don’t Have To Sell Plan B

plan-bThis issue gets thornier all the time. A federal appeals court let stand a lower court ruling that allows Washington state pharmacists to refuse to sell the Plan B emergency contraceptive pill on religious grounds.

The pill, which is sold by Barr Laboratories, prevents fertilized eggs from implanting, which some people believe is the same as abortion. Generally, Plan B is available over the counter to women who are at least 18 years old, but by prescription to those under 18.

US District Judge Ronald Leighton found that the state rules force pharmacists into an unconstitutional choice between their religious beliefs and their work, Reuters writes. State officials and several women had asked the Ninth US Circuit Court of Appeals to suspend the judge’s preliminary injunction, which bars them from enforcing the law, while they appeal his ruling.

In a split decision, the appeals court denied that request, finding that the state and the women didn’t show they would suffer irreparable harm if the injunction stays in place pending the appeal. The justices granted the state’s motion to speed up the appellate proceedings, which were set for oral argument on June 3 in Seattle.

Meanwhile, a group of pharmacists wants the Illinois Supreme Court to throw out a rule that forces them to dispense the Plan B emergency contraception pill despite their moral objections, claiming it amounts to illegal coercion. When we wrote about this legal battle two months ago, we ran a reader’s poll in which 70 percent of 143 respondents voted in favor of requiring pharmacist to dispense Plan B.

Cephalon Painkiller Could Be Devastating: FDA

fentoraThe agency is concerned that the powerful Fentora pain drug will be easily abused if made available on a widespread basis. Right now, the Cephalon lozenge is used to treat pain associated with acute pain suffered by cancer patients, but the drugmaker wants FDA approval to sell the narcotic to treat sudden pain in others.

Last September, the FDA issued an advisory linking Fentora to four deaths, and Cephalon blamed inappropriate prescribing for such ailments as back pain. The drugmaker, however, denied off-label marketing activities, which came under investigation by the US attorney in Philadelphia, the Connecticut attorney general, and a congressional committee. But next Tuesday, an FDA advisory committee will meet to review Cephalon’s request for wider approval.

“We are concerned that the sponsor’s request to expand the current indication…may greatly increase the prescribing of this product which may increase the availability of the product for diversion, abuse and misuse, and increase the incidence of accidental exposures which, due to the potency of the product, could potentially have devastating effects,” wrote Bob Rappaport, head of the FDA’s division of Anesthesia, Analgesia and Rheumatology in briefing documents.

If the agency did allow Fentora to be marketed to non-cancer patients with chronic pain, Cephalon would have to develop a risk management plan to mitigate abuse, he added. In its own briefing documents, has “extensive experience” in managing narcotic abuse, including its Fentora tablets.

Pfizer Lobbyist: Kickbacks To Docs Are Bad

bribeEspecially if those kickbacks are paid by insurers that give docs incentives to switch to a generic from Lipitor. And that’s the hot issue this week in the Colorado legislature, where a bill would prevent insurers from enticing physicians with cash to prescribe fewer brand-name meds.

The bill is opposed by AARP, Kaiser Permanente and the Colorado Association of Health Plans, but backed by patient advocates and Pfizer, the Associated Press reports. Pfizer lobbyist Colin Kennedy, however, declined to comment on whether the bill would benefit Pfizer financially. Nothing like candor to help vet the issues.

In fact, Pfizer is scrambling to bolster its best-selling cholesterol pill and has made a point of contacting state medical associations about insurer incentives in hopes of fending off cheaper generics. But what about enticements given docs to prescribe brand-name meds?

Ask Lynn Parry, the immediate past president of the Colorado Medical Society. She notes drugmakers are still able to offer lunches or dinners to provide info about a disease for which they sell a drug. “It’s not a hard sell by any means and I think they work as hard as they can to not directly influence, but they’re a business,” she tells the AP. Hmm… How much of a difference is there between incentives?

This debate has been popping up around the US over the past year, ever since a Michigan health plan rolled out an incentive plan that was widely criticized and then cancelled, but not before prompting a few states to consider legislation to limit or end the practice. Watch a video here.

One Colorado physician says the bill is a good idea. “If you just let money drive this, some people are going to get hurt,” Earl Carsten, a family practitioner, tells The Denver Post. “It bothers me that yu’d even have to think about a law prohibiting that.”

A Big Glass Of Water Helps The Nexium Go Down

tony-zookAstraZeneca’s Tony Zook ran into a lovefest the other day. The Wilmington Rotary Club serenaded the drugmaker’s US ceo with a song they warbled to the tune of Mary Poppins’ “A Spoonful of Sugar” at a luncheon Thursday. But perhaps the lyrics should have been ‘a big bucket of money helps the conflicted professor get paid.’

Speaking to more than 150 members of the service club, Zook touted AstraZeneca’s efforts to boost coverage for the uninsured during the luncheon at Hotel du Pont, located near AZ’s US headquarters. He noted AZ provided more than $400,000 worth of free meds in Delaware last year through patient assistance programs, and helped launch a public-private program aimed at 105,000 state residents who lack health insurance find health care services, The Wilmingon News-Journal writes.

During a question-and-answer session, one woman asked Zook whether the US could learn anything from health care systems in other countries. He replied that while other systems may “look good on paper,” governments often limit access to care by refusing to pay for products or services. “I don’t believe there’s a better health care system in the world than right here in the United States.” Yes, in other words, prices AZ can charge aren’t restricted. But he didn’t quite put it that way.

Another questioner related a story about his insurer swapped his wife’s Nexium prescription for a cheaper alternative that didn’t work as well. “Are they trying to keep profits out of your pockets?” the man asked Zook. The diplomatic AstraZeneca exec responded by saying he thinks insurers have good intentions, but “we would strongly disagree that people should be denied access to a product like Nexium.” Well, what did you expect him to say? A big glass of water, indeed.

Hat tip to PharmaGossip

It’s Only Money: The FDA & Foreign Plants

fdainthecrosshairsWhen it comes to the Heparin scandal, about the only thing anyone can seem to agree is on that the FDA needs to conduct more inspections of foreign manufacturing facilities. But how this would be accomplished - and funded - is the big question. And a congressional hearing yesterday seemed to do little to provide an answer.

A bill proposed by John Dingell, the Michigan Democrat who chairs the House Energy and Commerce Committee, would impose an annual fee for all domestic and foreign drugmakers to defray the costs. Foreign drugmakers would have to be inspected every two years like domestic manufacturers, a requirement that doesn’t exist right now.

Industry trade groups told Congress they’re willing to discuss a new user-fee system, within limits. Their issues include the size of the fees; commitments the funds will be focused on higher-risk overseas manufacturers; and assurances the system will not result in hindering the timely availability of pharmaceuticals in the US market, The Star-Ledger of New Jersey reports.

Consumers Union called the proposal “a reasonable way” to help pay for more foreign inspections, but cautioned drugmakers shouldn’t be allowed to use the fees as a way to “exert undue influence over FDA in its decision-making or other functions.”

Meanwhile, Janet Woodcock, who heads the FDA’s drug review division, backed away from earlier comments in which she seemed to acknowledge the FDA needs an extra $225 million to beef up foreign inspections. Democrats on Thursday thanked her repeatedly for that remark, which they seized on as ammunition in support of their bill. But under questioning, Woodcock refused to specify how much the FDA needs to inspect facilities properly. She was also hesitant to embrace proposed user fees for drug or device makers, The Wall Street Journal writes.

Merck’s Dick Clark Has An Epiphany

dickclarkThe plain-spoken ceo is on something of a confessional tour. His new mantra is to sound contrite. Rather than blame the media or some other group for Merck’s problems, Dick has recently taken to public hand-wringing when asked about not only the Vytorin scandal, but Merck’s credibility, in general. His new favorite phrase: ‘trust deficit.’ He uttered that last month in an interview and does so again this week.

“We need to do a better job as a company and as an industry. Having been at Merck for 35 years, we take way too much for granted. And I don’t think we’re aggressive enough in getting our stories out there,” Dow Jones reports him saying at a conference. “There’s a trust deficit around us as an industry, and somewhat as a company…I’ve become much more sensitive to issues around trust and what we can do to improve trust globally…I can’t blame the media. I have to blame us. We have to do a better job of it.”

Back in January, though, he was blaming the media for the Vytorin controversy. “With media hype, there is a great deal of confusion,” he told Wall Street analysts on a conference call (look here).

Actually, Merck is plenty aggressive. The issue, Dick, is which stories do you want told? The ones about playing Dodgeball with Vioxx data and how Vytorin endpoints are changed without the primary investigator being informed? If not, then ensure different practices are in place. Emphasizing other points or issues is no substitute and won’t deflect attention. But this is an industrywide problem, and it’s not new. Your challenge, Dick, is to do more than sound contrite. What’s your next move?

Hat tip to PharmaGossip and the WSJ Health blog

Up And Down The Ladder… Job Changes

hiredHired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs being announced each month. Despite downsizing, there is movement. Here are some of the latest changes. Recognize anyone?

AssureRx hired Al Lucas as vp of sales and marketing;
Oragenics added Marc Siegel and Kevin Sills to its board;
Noven Pharmaceuticals hired Peter Brandt as ceo and president;
Hyperion Therapeutics hired Bruce Scharschmidt as chief medical officer;
Cephalon hired Jerry Pappert as exec vp and general counsel;
MedThink Communications hired Steve Palmisano as vp medical communications;
HeartWare named Sepracor chairman Tim Barberich to its board;
Three Bridges Communications hired Susan Flinn as president;
Bioponic added Barbara Nabrit-Stephens to its scientific advisory board;
Migenix added Pieter Dorsman to its board;
Particle Sciences appointed Robert Lee vp, pharmaceutical development;
InSite Vision named Surendra Patel as vp of operations;
Ceregene hired Maurice Mezzino as vp, chief business officer;
Cerebene hired Andrea Loewen-Rodriguez as sr director, regulatory affairs;
Cell Therapeutics named Craig Philips as president;
Elite Pharmaceuticals named Stuart Apfel as chief scientific officer;
Haemacure named Dawn Benson as its director of quality control and assurance;
Haemacure named Ken Smith as director of manufacturing;
Aegera added Jeremy Curnock Cook and Gary Littlejohn to its board.
Shire added Michael Rosenblatt of Tufts University to it board.

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