Archive for June, 2007

On The Couch…..Lazy Afternoon Reading

mint-julep.jpgAs we bask in the good feeling that comes with completed errands and chores, what better way to celebrate than to catch up on events and happenings? And so we’ve gathered a few items that will, hopefully, make your day more enjoyable. Of course, on such a warm and sunny day, our antennae sometimes droop a wee bit. So if one flew by us unnoticed, please do write in and let us know. Meanwhile, enjoy….

* Pakistan’s pharma industry is very optimistic about exporting some $600 million in drugs by 2010, according to the country’s trade group. The Daily Times reports that would be a significant jump from $85 million this year. Presumably, this projection does not include heroin.

* Can pairing older drugs become a cure for the blockbuster blues? The New York Times profiles CombinatoRx and other biotechs that are hoping to strike it rich and fill pipelines to bursting.

* A new report recommends that Maryland must find new ways to attract biotechs to locate, and remain, in the state. The Baltimore Sun writes that officials shouldn’t expect companies to leave Boston, and should focus on courting companies from outposts where biotech isn’t thriving, such as Cleveland.

* The crystal ball was pulled out of the editor’s closet at The Economist, which catches up on hand-wringing reports released recently by PricewaterhouseCoopers, the consulting types, and PharmaFutures, an adhoc group of pension fund managers, industry execs and analysts. The conclusion - as if you didn’t already know? - pharma must change.adirondack-chair.jpg

* The CDC has delayed a vote on MedImmune’s FluMist for kids under 5, which means the company is likely to miss out on that portion of the market the upcoming flu season, The Washington Post reports. Wonder how this will sit with AstraZeneca investors? Hmm… That $15.6 billion purchase price for MedImmune looks more expensive every day.

* Novartis and Ciba Specialty Chemicals, which the drugmaker once owned, are both being sued by New Jersey’ Department of Environmental Protection for pollution damages at 1,350-acre site, according to The Asbury Park Press.

* Officials in a Florida county are embarassed by the slow progress of a planned bio-pharmaceutical park in land left barren by the 1980 Liberty City riots. The problems? There are no tenants lined up, the local NBC affiliate reports, and the developer happens to be under criminal investigation. They should chat with their counterparts in Maryland (see above).

* AstraZeneca execs tells Interfax China about their plans to use the Asian nation as a global supply hub.

Merck Hires CFO Away From Biogen Idec

pkellogg.jpgPete Kellogg will join the drugmaker on August 14 to succeed Judy Lewent, who is retiring shortly. The former Frito-Lay cfo and Arthur Andersen partner, who worked at Biogen Idec since 2000, will also become executive vice president and report to Merck ceo Dick Clark.

This is the second big drugmaker to name a new cfo in as many days. Yesterday, Wyeth promoted Greg Norden to replace Ken Martin, who is also retiring. These retirements, coupled with the rash of recent departures of cfo’s from Amgen, Pfizer and AstraZeneca, has suddenly raised the value of high-profile numbers crunchers who know how to slap investor backs and soothe impatient fund managers.

Biogen, meanwhile, hopes to find a replacement within the next several weeks.

Sanofi-Aventis Gives Up On Acomplia

fat2.jpgThe drugmaker plans to withdraw its application with the FDA to sell its controverial diet pill in the US, according to a statement issued a short while ago. Nonetheless, the drugmaker vows to resubmit its request “at a future date…Sanofi-Aventis is committed to making all efforts necessary to make rimonabant available to patients in the US.”

This is hardly surprising. An FDA advisory committee panel earlier this month unanimously voted against recommending the diet drug after hearing evidence that Acomplia increases the risk of suicidal behavior - three patients committed suicide during trials. Sanofi-Aventis didn’t help its cause by failing to convince the panel that the pill is safe.

The decision was a huge blow to the drugmaker, which already sells the diet pill in other countries, but was counting on the huge US market to make Acomplia a blockbuster and revive its growth.

Improper Marketing As An Infectious Disease: Pfizer And Unapproved Viracept Materials

viracept22.jpgSo many allegations, so little time. As Pfizer investigates charges made by sales reps that its HIV sales team was encouraged to improperly promote two drugs - maraviroc, which isn’t yet approved by the FDA - and the aging Viracept pill, there are numerous examples to share. This latest batch of slide printouts were allegedly given to sales reps to show to docs and nurse practitioners, according to a sales rep who has complained to the drugmaker and was questioned as part of the internal probe.

The issue with these materials? The sales rep alleges the slides were never approved by Pfizer’s own Review Committee and they violate company policy due to the content. Specifically, the rep says the slides must must have ‘fair balance’ and also be able to back up scientific claims, such as with head-to-head comparisons. You can read more about those rules, which begin on page C1 of Pfizer’s Health Compliance Manual. Before we get to the slides, this is what the sales rep has to say:

“Viracept is an HIV drug and you can’t use it for anything else. There’s no other disease to talk about, so you can’t promote it for anything else. You want to make claims of superiority, but if you lose the potency argument, which we did with Viracept, then you make claims of safety. And these handouts were used to show other HIV drugs were unsafe, which is another way of saying, by default, that Viracept must be safer. But there were problems with them. None of this data is accurate as far as a promotion of Viracept is concerned. It only says Kaletra is bad, Reyataz is bad, so Viracept must be safer. But there’s no proof offered.”

This first slide discusses the influence of HIV drugs on on lipid levels in hepatitis C patients, and raises issues with Abbott’s Kaletra, a widely used AIDS med. But the sales rep alleges that “there is no balance. There is no mention of what risks Viracept may have. It has no package labeling. It is clearly designed to make a false safety claim by saying Kaletra is unsafe with patients who have hepatitis C. It makes mention of a study that is not comparative with other studies, or Viracept compared to Kaletra.”

Read more »

A Drugmaker’s Lawyer Talks Compliance

tom-sabatino.jpgSchering-Plough is no stranger to compliance problems. Huges fines were paid to resolve manufacturing and marketing violations in recent years. Beyond the ceo, who must avoid - or clean up - such a mess? The general counsel, of course. The Metropolitan Corporate Counsel spoke with Tom Sabatino, the drugmaker’s chief lawyer, about his views of compliance issues. This is an excerpt. One caveat: this is either very tightly edited or, more likely, reflects carefully crafted hand-written responses. We are talking about lawyers, after all.

MCC: How would you characterize the role of the general counsel?

Sabatino: The general counsel often sits at the fulcrum of decision making in a corporation, especially where he has a deep understanding of the business dynamics and challenges that drive the corporation. He is frequently in the best position to see both the opportunities and risks of a given business decision and he can give the CEO, other members of senior management, and the board a balanced view and advice. The general counsel is also frequently seen as a moral compass for the organization - helping to ensure that the organization “does the right thing,” not just the legally acceptable thing. This behavior reinforces a corporation’s commitment to good corporate governance and compliance and amplifies the right “tone at the top.”

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Lilly May Face Still More Zyprexa Lawsuits

zyprexa.jpgThat’s the speculation now that an FDA letter to the drugmaker has surfaced. In March, the agency told Lilly it would delay the approval of Symbyax for depression, because more info was needed about the risk of diabetes in the prescribing label. Symbyax combines Lilly’s antipsychotic Zyprexa and its Prozac antidepressant.

Lilly’s proposed prescribing information for Symbyax failed to disclose that almost half of patients who had high or borderline levels of blood sugar when they started taking the drug ended up with levels high enough to be considered diabetic, the FDA said in its letter. That was more than nine times the number of patients on placebos, or inactive dummy pills. “We were troubled that this important information was not included in your proposed label,” the agency said in its letter.

The FDA’s request, in a letter to Lilly obtained by Bloomberg News, may bolster plaintiffs’ suits against the drugmaker over side effects tied to Zyprexa, lawyers say. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren’t adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.

“When the FDA says something damning about the warnings of a drug, it’s admissible as evidence on the reasonableness of the manufacturer’s decisions,” David Logan, dean of the Roger Williams University School of Law in Bristol, Rhode Island, tells the wire service. “It would likely carry some weight with juries.”

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Pharma Can’t Pin Liability On Docs

blamegame.jpgIn a setback for drugmakers, the West Virginia Supreme Court of Appeals ruled that pharma can’t escape liability for harmful prescriptions by blaming problems on the docs. At issue is the notion of ‘learned intermediary,’ which says a doc presumably has enough info to make a prudent prescribing decision, absolving a drugmaker of any subsequent problem with a patient.

The state’s Chief Justice, Robin Davis, treated the doctrine as a useless 82-year-old relic. “When the learned intermediary doctrine was developed, direct to consumer advertising of prescription drugs was utterly unknown,” she wrote. “Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians.”

The law, she wrote, created an exception to the duty of a manufacturer to warn consumers directly of risks. “For good or ill, that has all changed,” Davis continued. “…we now hold that, under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers.”

But one justice called the majority “exceptionally shortsighted.” “Just because a warning can be printed and advertised as part of the marketing plan for a prescription drug does not mean that a consumer, especially one not educated in medical jargon, can digest or comprehend the significance of that warning in a useful fashion,” Joe Albright wrote.

Yet another justice, Spike Maynard, fired back that if the dissenters had their way a small town doctor would become solely responsible for an injury, “while an out of state multi million dollar drug manufacturer is off the hook,” according to The West Virginia Record.

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Wyeth Names New CFO…Who’s Next?

cfo2.jpgSo shortly after Ken Martin tires of being a cog in the wheel and resigns as cfo, Wyeth promotes Greg Norden, 49, to cfo, senior vp and official cog. Greg was previously exec vp and cfo of the Wyeth Pharmaceuticals division, and he’s been with the company since 1989.

This is the first cfo replacement to be announced since a rash of cfo departures began this spring. Among the others: Pfizer’s Alan Levin, Amgen’s Richard Nanula, AstraZeneca’s Jon Symonds and Merck’s Judy Lewent.

Given the difficulties in dealing with investors anxious over pipelines and the sudden competition for talent, the other companies may wind up doing what Wyeth did today - promote from within. There’s speculation, for instance, that Merck may tap someone from one of its other units, such as Merck Frosst, to replace Lewent. After all, why wouldn’t a medium-sized cog want to be a big cog?

Circumcision Could Cut HIV Cases

HIV VirusA new report from the Global HIV Prevention Working Group projects 60 million new cases of HIV infection by 2015, assuming current strategies to contain the virus are kept in place. But if spending increases and better prevention tactics are used, that number could drop by half.

Such as? By itself, male circumcision on a broader scale in harder hit nations could lead to an 8 percent drop, the report said. (Never mind that circumcision is a tough cultural sell in many places). The working group, an international panel affiliated with the Henry J. Kaiser Family Foundation and the Bill & Melinda Gates Foundation, is calling for an doubling of global spending on HIV/AIDS to $22 billion by 2010.

Riding Michael Moore’s Coattails

sicko-poster.jpgLove it or hate it, Michael Moore’s acerbic brief for universal health care, “Sicko,” was able to generate a bushel of hype in advance of its nationwide release tomorrow. Not so “Salud,” another documentary on health care that came out this spring, with considerably less fanfare. One of the most controversial parts of Moore’s film was his journey to Cuba, seeking care for three ill 9/11 rescue workers. “Sicko” shows the three receiving free care from a battery of doctors, but Moore said he insisted the treatment match what the average Cuban would get from the government.

“Salud” takes a more in-depth look at the Cuban health care system, but comes away with an equally upbeat assessment. Now director Connie Field, who made “The Life and Times of Rosie the Riveter” and other critically acclaimed documentaries, is trying to build more buzz for the movie by tying into the “Sicko” debate. One person plugging “Salud”: former U.S. Surgeon General Joycelyn Elders, who calls it an “excellent, accurate and deeply moving portrayal.” Elders, however, hasn’t been seen plugging SiCKO. Wonder why…..

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