Thursday, July 31, 2008

FDA Contradicts Genentech on Eye Drug

An FDA letter to Senate investigators appears to contradict one of Genentech’s main reasons for restricting the distribution of its cancer drug Avastin.


Last year, the company said it would no longer sell the drug to compounding pharmacies, which repackage Avastin for use in patients with eye disease. In an open letter, the company said it was making the switch in part because of FDA inspectors’ concerns that some batches of the drug didn’t meet standards for use in the eye.


“In order to resolve the concerns raised by the FDA, we destroyed four batches of Avastin deemed unsuitable for use in the eye,” the letter said. The letter added: “These lots would have been entirely suitable for its approved use as an intravenous cancer medication.”


But the FDA says its inspectors “identified deficient practices and the lack of of effective processes to know what was in those four lots. Consequently, the Agency recommended that those lots should be considered unfit for use for any indication.”


That statement comes in a letter the agency sent in response to questions from Sen. Herb Kohl (D-Wisc.), chairman of the Senate Special Committee on Aging.


Genentech also sells Lucentis, a drug that is similar to Avastin and that has been approved for an eye disease called wet age-related macular degeneration. A dose of Lucentis for the disease costs roughly ,000; a comparable dose of Avastin costs about .





J&J, Red Cross Stop Suing Each Other

The lawsuits had an absurdist, has-it-really-come-to-this quality about them. Johnson & Johnson and the Red Cross — Band-Aids and baby powder, blood drives and disaster relief — were suing each other over the rights to the red cross emblem that both had long shared.


Now, after getting most of its suit against the Red Cross tossed out by a judge, Johnson & Johnson has picked up its legal toys and gone home. The company said today that it is dismissing its remaining claims against the august nonprofit. And the Red Cross, for its part, threw out its counterclaims against J&J. The companies’ statement is online here.


J&J’s own house blogger captured the spirit of the whole thing pretty well when the first suit was filed last summer:


    As a former journalist, I appreciated how undeniably juicy the story would be: Johnson & Johnson sues the American Red Cross and other parties over�. What?! � the use of the RED CROSS?!

The post went on to explain the details of the case, and how it had come to wind up in court. The bottom line was that the Red Cross had started licensing the red cross emblem to be used on retail goods such as baby products and first-aid kits. J&J didn’t like that, so they sued. Then, sigh, the Red Cross countersued.


By last month, the judge had dismissed most of the claims on both sides. Today’s news puts a final stop on the whole thing, apparently leaving everything as it was before. “We join with the Red Cross in expressing our pleasure that this dispute is over,” J&J CEO Bill Weldon said in a statement.





Sunday, July 27, 2008

A Doctor?s Lessons From a Dying Patient

Sometimes patients know they’re about to die. Doctors, accustomed to saving lives rather than passively awaiting death, don’t always handle those situations all that well.


“Even though death is an inevitable part of the human condition, it’s not something that most doctors, including me, ever get too comfortable with,” family doc Ben Brewer writes this week in his WSJ column. “We get used to pushing it off until another day.”


But, Brewer writes, the final few days of a patients life can be illuminating for doctors who make the time. He describes the last days of a 95-year-old patient who came down with pneumonia.


The patient took to telling stories of his youth. He described visiting Germany with his family as a young man, during the 1930s. At one point, as he was walking down a deserted street, he encountered a soldier who stopped, raised his hand and said, “Heil Hitler.”



    My patient, who wasn’t Jewish but wasn’t saying “Heil Hitler” to anybody, affected a broad smile, and replied, “Good morning,” as pleasantly as he could. He kept walking without looking back and wondered if he would still have his head as he passed by. He survived unharmed.


A few days after hearing that story, Brewer walked back into the patient’s room and offered his own good morning. The patient didn’t reply, and soon died quietly.


Sit Down and Chat: Join Dr. Brewer in a discussion about the relationship between doctor and patient as the end of life nears in his online forum


Photo: iStockphoto





Sanofi?s $2 Billion Generics Play

Sanofi today offered about $2 billion to buy the outstanding shares of Czech generics shop Zentiva, Dow Jones Newswires reports. The offer is a bet on both the generics business and Eastern Europe.


The company already owned about 25% of Zentiva. Today’s bid seemed to be prompted by a recent offer by Czech finance group PPF to buy the company. (Sanofi’s play represents a 10% premium to the PPF bid.)


But even if PPF forced Sanofi’s hand, it’s understandable why the company might want Zentiva. With its classic Big Pharma combo of strong cash flow and looming patent expirations, Sanofi needs to make some deals.


Generics has been a strong business lately, though the margins are slim compared with brand-name medicines. Sanofi’s European rival Novartis has seen solid growth from its generics unit Sandoz, even as its sales of branded drugs have been sluggish.


And Eastern European countries where Zentiva is strong are just the kind of upper-middle-income markets where drug makers hope to see growth across the board.





Sunday, July 20, 2008

Countdown to Expiry: Lipitor Goes Generic on 11/30/11

Start the countdown. On Nov. 30, 2011, Lipitor, the biggest selling drug of all time, will face generic competition.


Pfizer, which sells the cholesterol drug, has been battling generics manufacturer Ranbaxy to protect the Lipitor cash cow for a few more years. Ranbaxy had been pushing to sell the drug in 2010, when the basic patent expires; Pfizer had argued that various other patents should keep the drug locked up until 2016.


Now the companies have settled their legal fight and Ranbaxy is in the clear to start selling generic atorvastatin in late 2011. Pfizer’s Ian Read, president of worldwide of pharmaceutical operations, called the deal “a win-win-win because it is pro-patient, pro-competition and pro-intellectual property.”


Sounds nice. But the end of patent protection for Lipitor will still be a huge blow to Pfizer, which stands to lose some $10 billion a year in revenue. Already sales of the medicine have softened as many patients choose cheaper cholesterol drugs, like simvastatin, sold by Merck as Zocor.


As the first company to challenge the patents, Ranbaxy will get to spend a lucrative six months as the sole generic manufacturer of the drug. The deal doesn’t apply to challenges from other generic manufacturers, but the Ranbaxy challenge was among the most significant.


Then end of Lipitor will mark the biggest blow to Big Pharma’s chronic disease gravy train so far. Lipitor and other brand-name medicines like it have been taken by a broad swath of the population for life. With many of those categories saturated, like depression and high blood pressure, the market and the FDA are casting a wary eye on new brands for a wide range of diseases.


Photo: Associated Press





Fish Oil Pinch Spurs Search for Alternative Omega-3s

The global commodities boom extends even to the ocean depths: The price of crude fish oil has nearly tripled in the past five years.


This matters to you, Health Blog reader, because fish oil is a primary source of omega-3 fatty acids, the nutritional supplements that may reduce the risk of heart disease and a host of other ailments.


The price has been rising as Baby Boomers (and others) have been swallowing ever more fish oil. Global fisheries, alas, are already under pressure and can’t keep up with the habit.


Responding to this growing imbalance, some big corporate players are using biotech gene-splicing techniques to create land-based supplies of omega-3s, Dow Jones Newswires reports.


DuPont hopes to use genetically modified yeast to crank out omega-3s. Monsanto is trying soy beans. And Dow AgroSciences and Martek Biosciences are splicing algae genes into canola seeds. The products could come to market within the next few years.


Consumers may initially be wary of nutritional supplements created through gene splicing. But, as a Monsanto VP told Dow Jones, “There’s just not enough fish in the ocean.”


Photo by spcummings via Flickr





Saturday, July 12, 2008

St. Louis: Dreaming of Budweiser, Working in Health Care

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InBev’s bid to buy Anheuser Busch is tugging at the heartstrings of St. Louis, the brewer’s home town.


But perhaps its time for the town to reconsider its Budweiser-centric self image, local business columnist Mary Jo Feldstein writes in this morning’s St. Louis Post-Dispatch.


With about 6,000 employees in the St. Louis area, A-B doesn’t even make the top 10 list of largest local employers. But three hospital networks do. BJC Healthcare, the area’s biggest employer, has more than 23,500 people on staff.


The big pharmacy benefits manager Express Scripts is also in the area, as is the managed care company Centene. Feldstein thinks Express Scripts might do well to find a “marketing mascot” to win over local hearts. “Drugs MacKenzie, perhaps?” she asks.


Biotech agricultural giant Monsanto may no longer be a health-care company since the wheeling and dealing that sent its G.D. Searle pharma unit to Pfizer via Pharmacia. But Monsanto’s still close kin in terms of research and remains based in town. The company has seen fast growth during recent years, while things at A-B have been pretty flat.


The shift from old-line industries to health care is happening in many corners of the country — witness Pittsburgh and Detroit, to name a couple we’ve written about before. But somehow, health-care jobs don’t seem to captivate the popular imagination like, say, Clydesdales and beer.


“St. Louisians aren’t very interested in companies with quadrupling stock prices, fast-rising revenue or massive increases in profit,” Feldstein writes. “We prefer those with Super Bowl commercials.”


Photo from Associated Press