A look inside the FDA, its recent record, and the debate over whether our nation's drug safety system is broken.
Thursday, November 13, 2003
frontline: the other drug war | PBS
The consumer movement that started with those bus trips to Canada is poised for a possible major victory over the pharmaceutical industry. But the question remains: How much will that potential victory benefit the pocketbooks of consumers? And what will be the bottom-line impact on drug companies and their incentive to develop new innovative drugs in the future?
frontline: the other drug war | PBS
frontline: the other drug war | PBS
Wednesday, October 08, 2003
Pfizer Drig Inspira gets FDA approval
WASHINGTON (Dow Jones/AP) -- Pfizer Inc. has won regulatory approval for its drug Inspra, which is designed to keep heart-failure patients alive longer, the company said Wednesday.
The Food and Drug Administration said Inspra is the first drug to be approved for this use in the class of blood pressure lowering agents called aldosterone receptor blockers.
Inspra, known chemically as eplerenone, is more effective than the current standard treatment for people with heart failure who have had a heart attack, according to Pfizer's trials.
Inspra will be on the market in December 2003, but some heart patients will get it in November through an early-access program.
Heart failure occurs when a weakened heart can't effectively pump oxygen-rich blood throughout the body. About one-third of heart-attack survivors develop heart failure, according to the National Institutes of Health.
New York-based Pfizer had 2002 revenue of $32.37 billion.
The Food and Drug Administration said Inspra is the first drug to be approved for this use in the class of blood pressure lowering agents called aldosterone receptor blockers.
Inspra, known chemically as eplerenone, is more effective than the current standard treatment for people with heart failure who have had a heart attack, according to Pfizer's trials.
Inspra will be on the market in December 2003, but some heart patients will get it in November through an early-access program.
Heart failure occurs when a weakened heart can't effectively pump oxygen-rich blood throughout the body. About one-third of heart-attack survivors develop heart failure, according to the National Institutes of Health.
New York-based Pfizer had 2002 revenue of $32.37 billion.
Thursday, September 25, 2003
Tuesday, September 23, 2003
Friday, September 12, 2003
The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant
Excellent resource on the pharmaceutical industry. Fran Hawthorne has done a good job writing about issues affecting all big pharmaceutical companies. She raises legitimate questions about some of the industry marketing practices. She portrays Merck as historically superior in good business practices and good public relations. However, Merck may not be able to replace profits from older drugs as patents expire, and that makes staying "one of the good guys" more difficult. They are becoming more defensive about patent expirations (as other companies have been) and more aggressive with marketing. It seems its may no longer be able to depend on the "pipeline" of drugs from research and development to maintain its profitability. The book seems to warn of difficult times ahead, with profitability outweighing all other factors in new drug development.
Amazon.com: Books: The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant
Amazon.com: Books: The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant
Sunday, September 07, 2003
Eli Lilly raises earnings forecast
By Juliann Walsh / Bloomberg News
Eli Lilly & Co., the maker of Prozac antidepressant pills, raised its 2003 earnings forecast on demand for psychiatric medications including Zyprexa for schizophrenia and new drugs such as Cialis to treat impotence.
Lilly now expects full-year net income of at least $2.32 a share, Chief Financial Officer Charles Golden told investors at a meeting in New York. That's compared with the Indianapolis- based company's previous estimate of $2.27 to $2.37 a share.
Chief Executive Sidney Taurel is counting on new medicines to boost earnings as Zyprexa, Lilly's top-selling product with $3.69 billion in sales last year, faces pressure from competitors such as Bristol-Myers Squibb Co.'s Abilify. Demand for Cialis, under review for U.S. approval, has exceeded expectations in the countries where it's been introduced, the company said.
"Lilly has one of the best new product lines in the industry," said Samuel Isaly, manager of the Eaton Vance Worldwide Health Sciences Fund, which owns about 1.9 million Lilly shares. Cialis and Strattera for attention-deficit disorder "will become billion-dollar drugs."
The company had net income of $2.50 a share last year. This year's profit will be hurt by costs taken in the first quarter to cut jobs and write down the value of assets, Lilly has said.
Shares of Lilly slipped 4 cents to $61 as of 4 p.m. in New York Stock Exchange composite trading. They've risen 8.5 percent in the past 12 months, beating a 1 percent gain in the 12-member Standard & Poor's 500 Pharmaceuticals Index. Pfizer Inc., the world's biggest drugmaker, this week reduced estimates for 2003 because of costs for the company's acquisition of Pharmacia Corp.
Taurel said he plans to add sales representatives to promote new products. Lilly's global sales force will climb to 17,500 by the end of 2004 from about 14,500 now, he said in an interview.
In addition to the recent introductions of Cialis, Strattera and Forteo for osteoporosis, Lilly said it's preparing to roll out four new products, including Alimta for cancer and Symbyax for bipolar disorder. The company said it expects to have four drugs with annual sales of more than $1 billion by the end next year, compared with just one now.
"Lilly is suffering less" than rivals such as Merck & Co. and Pfizer from expiring patents, said Victor Polak, who helps oversee $250 million in assets at Citigroup Asset Management. The Food and Drug Administration has been reviewing plants in Indianapolis after Lilly failed two previous inspections. The agency has refused to approve the company's new drugs until the manufacturing issues are resolved.
"We believe the FDA is in the final stages of its overall assessment," Taurel said in the statement. "We expect to have more clarity during the fourth quarter."
Taurel added that the company would give 2004 earnings forecasts in January, after the FDA offers its decision on Cymbalta approval.
Eli Lilly & Co., the maker of Prozac antidepressant pills, raised its 2003 earnings forecast on demand for psychiatric medications including Zyprexa for schizophrenia and new drugs such as Cialis to treat impotence.
Lilly now expects full-year net income of at least $2.32 a share, Chief Financial Officer Charles Golden told investors at a meeting in New York. That's compared with the Indianapolis- based company's previous estimate of $2.27 to $2.37 a share.
Chief Executive Sidney Taurel is counting on new medicines to boost earnings as Zyprexa, Lilly's top-selling product with $3.69 billion in sales last year, faces pressure from competitors such as Bristol-Myers Squibb Co.'s Abilify. Demand for Cialis, under review for U.S. approval, has exceeded expectations in the countries where it's been introduced, the company said.
"Lilly has one of the best new product lines in the industry," said Samuel Isaly, manager of the Eaton Vance Worldwide Health Sciences Fund, which owns about 1.9 million Lilly shares. Cialis and Strattera for attention-deficit disorder "will become billion-dollar drugs."
The company had net income of $2.50 a share last year. This year's profit will be hurt by costs taken in the first quarter to cut jobs and write down the value of assets, Lilly has said.
Shares of Lilly slipped 4 cents to $61 as of 4 p.m. in New York Stock Exchange composite trading. They've risen 8.5 percent in the past 12 months, beating a 1 percent gain in the 12-member Standard & Poor's 500 Pharmaceuticals Index. Pfizer Inc., the world's biggest drugmaker, this week reduced estimates for 2003 because of costs for the company's acquisition of Pharmacia Corp.
Taurel said he plans to add sales representatives to promote new products. Lilly's global sales force will climb to 17,500 by the end of 2004 from about 14,500 now, he said in an interview.
In addition to the recent introductions of Cialis, Strattera and Forteo for osteoporosis, Lilly said it's preparing to roll out four new products, including Alimta for cancer and Symbyax for bipolar disorder. The company said it expects to have four drugs with annual sales of more than $1 billion by the end next year, compared with just one now.
"Lilly is suffering less" than rivals such as Merck & Co. and Pfizer from expiring patents, said Victor Polak, who helps oversee $250 million in assets at Citigroup Asset Management. The Food and Drug Administration has been reviewing plants in Indianapolis after Lilly failed two previous inspections. The agency has refused to approve the company's new drugs until the manufacturing issues are resolved.
"We believe the FDA is in the final stages of its overall assessment," Taurel said in the statement. "We expect to have more clarity during the fourth quarter."
Taurel added that the company would give 2004 earnings forecasts in January, after the FDA offers its decision on Cymbalta approval.
Monday, August 25, 2003
Financial Times gets it right
This weekend's headline was on a compromise made in the WTO which allows more patent-protected drugs to get to the impoverished. The article was too short, but at least some recognition was given the subject's importance. It makes me wonder if patents could be based more on "free market" value rather than strict time limits. If patents weren't horded so closely, and the motivation for piracy was lessened by more inherent flexibility, we might all benefit.
Physicians for a National Health Program - Health Care is a Human Right: "
'Mankind has become so much one family that we cannot ensure our own prosperity except by ensuring that of everyone else.' - Bertrand Russel "
'Mankind has become so much one family that we cannot ensure our own prosperity except by ensuring that of everyone else.' - Bertrand Russel "
Wednesday, August 20, 2003
Sunday, August 17, 2003
statesman.com | Smallpox vaccinations seem effective for life: "
ADVERTISEMENT
By Jeff Nesmith
WASHINGTON BUREAU
Sunday, August 17, 2003
WASHINGTON %u2014 Americans vaccinated for smallpox 50 or more years ago may still be immune to the disease, scientists said Sunday.
Scientists have feared that immunity to the disease has 'run out' for people vaccinated prior to the mid-1970s, when vaccinations ended in America."
ADVERTISEMENT
By Jeff Nesmith
WASHINGTON BUREAU
Sunday, August 17, 2003
WASHINGTON %u2014 Americans vaccinated for smallpox 50 or more years ago may still be immune to the disease, scientists said Sunday.
Scientists have feared that immunity to the disease has 'run out' for people vaccinated prior to the mid-1970s, when vaccinations ended in America."
Thursday, July 31, 2003
Parata Systems and D&K Healthcare Resources Partner to Bring Next-Generation Dispensing Solution to Community Pharmacies
Thursday July 31, 4:15 pm ET
D&K Healthcare Exclusive Distributor in 23-State Service Region for Parata's Next-Generation Robotic Dispensing Solution
Damn! No wonder the pharmacists have seemed so grumpy lately! Things are just going from bad to worse for them. First neighborhood drug stores are stomped out by superstore-pharmacies, now this. Maybe they'll catch less abuse from angry customers, like when insurance/bureacracy screws them over, its the person at the counter that catches flak. Oh well.
Thursday July 31, 4:15 pm ET
D&K Healthcare Exclusive Distributor in 23-State Service Region for Parata's Next-Generation Robotic Dispensing Solution
Damn! No wonder the pharmacists have seemed so grumpy lately! Things are just going from bad to worse for them. First neighborhood drug stores are stomped out by superstore-pharmacies, now this. Maybe they'll catch less abuse from angry customers, like when insurance/bureacracy screws them over, its the person at the counter that catches flak. Oh well.
Wednesday, July 30, 2003
But critics of the bioterror campaign respond that even if there is some secondary good to be derived from that effort, it's still far from the most efficient way to patch a public health system turned decrepit and outdated.
''What a stupid way to develop things,'' BU's Ozonoff said. ''That's like saying, `What I'd like is a nice orange drink called Tang, so let's design a space system so we can have Tang.' ''
This story ran on page C4 of the Boston Globe on 7/29/2003.
Welcome to the monkey house, Mr Ozonoff! I love his analogy, but I think it speaks to the way humans approach most of our problems most of the time.
''What a stupid way to develop things,'' BU's Ozonoff said. ''That's like saying, `What I'd like is a nice orange drink called Tang, so let's design a space system so we can have Tang.' ''
This story ran on page C4 of the Boston Globe on 7/29/2003.
Welcome to the monkey house, Mr Ozonoff! I love his analogy, but I think it speaks to the way humans approach most of our problems most of the time.
Tuesday, July 29, 2003
I found an interesting website from a group called the Galen Institute. Their motto is:
A VISION FOR CONSUMER-DRIVEN HEALTH CARE REFORM "The market is distorted by a tax policy that is mistargeted, miscalibrated, and open-ended. This tax policy provides generous benefits to those who have higher incomes and receive health insurance through the workplace. Yet it offers little or no assistance to those at the lower end of the income scale." They sound like they might have their hearts in the right place, but the site is suspiciously slick, the design is decidedly "corporate." There is a lot of double-talk about "choice" and the "free-markets" when the main problem is the number of people not getting healthcare at all. Perhaps the institute will be effective lobbying, but it seems to me that the only way to comprehensive health care is through government programs. Public health is too big a problem and not profitable enough to let "markets" dictate policy.
A VISION FOR CONSUMER-DRIVEN HEALTH CARE REFORM "The market is distorted by a tax policy that is mistargeted, miscalibrated, and open-ended. This tax policy provides generous benefits to those who have higher incomes and receive health insurance through the workplace. Yet it offers little or no assistance to those at the lower end of the income scale." They sound like they might have their hearts in the right place, but the site is suspiciously slick, the design is decidedly "corporate." There is a lot of double-talk about "choice" and the "free-markets" when the main problem is the number of people not getting healthcare at all. Perhaps the institute will be effective lobbying, but it seems to me that the only way to comprehensive health care is through government programs. Public health is too big a problem and not profitable enough to let "markets" dictate policy.
Shares of Elan fall 25% on July 25, after a setback in Antegren drug trial for Crohn's Disease, a painful gastrointestinal disorder. Antegren was jointly developed by Elan of Ireland and Biogen of Cambridge, Massachusetts. Biogen shares fell $2.48 to $38.70 on Nasdaq, but Elan of Ireland can not absorb the setback nearly as well. Biogen is confident in Ategren's promise as a treatment for multiple sclerosis. Elan also had a failure with an Alzheimer's vaccine, which caused dangerous brain swelling in test subjects. It is interesting how the very big, very profitable Biogen can take such a setback in stride while it is disasterous for its smaller, partner company.
Pharmaceutical giant Roche agreed to buy Igen International for 1.26 billion dollars. Igen patented an amino acid-based technology for diatgnostic tests. "Igen won a 505 million dollar judgement against Roche. In July the court reduced the amount to $19 million, but gave Igen the right to cancel the license. This right apparently gave Roche the incentive to buy the Maryland company outright. Supposedly there is a plan to sell most of the company's assets back to the shareholders, although this is counterintuitive, especially in light of speculation that Roche overpaid for the investment in Igen's technology.
Monday, July 28, 2003
At News.ft.com Special Reports
Healthcare: Pharmaceuticals
The pharmaceuticals industry is having to rethink the way it creates its own growth products. The bigger companies are forced to make alliances with smaller colleagues to acquire new drugs but at the same time the industry faces a squeeze on prices. Overshadowing this process is the industry's dominance of the moral high ground as it grapples with the problem of how poor people can afford expensive treatments.
ContentsFT.com / Healthcare 2003
Healthcare: Pharmaceuticals
The pharmaceuticals industry is having to rethink the way it creates its own growth products. The bigger companies are forced to make alliances with smaller colleagues to acquire new drugs but at the same time the industry faces a squeeze on prices. Overshadowing this process is the industry's dominance of the moral high ground as it grapples with the problem of how poor people can afford expensive treatments.
ContentsFT.com / Healthcare 2003
Saturday, July 26, 2003
Alan Sager and Deborah Socolar run a Health Reform Program at Boston University
They also have a lot of good information at dcc2.bumc.bu.edu/hs/ushealthreform.htm
They also have a lot of good information at dcc2.bumc.bu.edu/hs/ushealthreform.htm
Friday, July 25, 2003
Forbes.com has an interesing article that starts: "The $400 billion Medicare prescription drug benefit making its way through both houses of Congress has a somewhat surprising backer: the drug industry. Big pharma sees an opportunity to cool the heated criticism about the high cost of branded medicines and at the same time give the 40 million Americans on Medicare more access to its medicines, thereby increasing sales. "
Thursday, July 24, 2003
www.business.com/directory/pharmaceuticals_and_biotechnology/news/
The major motivation for the press to be comprehensive or accurate is when consumers demand information for the purpose of making money. Money makes money. Seeing through political propaganda relatively easy: http://phrma.org, but I've found for raw information, the business press is most useful.
The major motivation for the press to be comprehensive or accurate is when consumers demand information for the purpose of making money. Money makes money. Seeing through political propaganda relatively easy: http://phrma.org, but I've found for raw information, the business press is most useful.
Tuesday, July 22, 2003
Yesterday the Financial Times contains an article which mentions "lingering doubts about whether Britsol Myers has been a bad seed in corporate America. There was one section in particular which avoids placing blame by complicating sentence structure and using the passive voice.
Inventory and accounting problems led the company to restate $2.5bn in slaes and $1bn in profits (I'm not sure if this is American billions, x,000,000,000 I assume it is) for the years 1999-2002. Bristol says that some of its managers pushed stock levels to unsustainable levels using sales incentives. They did this so that it would look like large quantities of its drugs were sold when they simply been shipped to distributers.
Inventory and accounting problems led the company to restate $2.5bn in slaes and $1bn in profits (I'm not sure if this is American billions, x,000,000,000 I assume it is) for the years 1999-2002. Bristol says that some of its managers pushed stock levels to unsustainable levels using sales incentives. They did this so that it would look like large quantities of its drugs were sold when they simply been shipped to distributers.
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