In the Spotlight
Red tape costs lives in Africa.
Why the fear of fraud shackles foreign aid and what we can do about it.
Roger Bate, Benjamin Schwab, Center for Medical Progress, 3-24-05
With the ever expanding AIDS pandemic, many have called on developed nations to substantially increase their aid budgets. At the same time, many also want increased accountability from agencies and governments receiving the windfall to protect against fraud and abuse. This has the makings of a perfect storm, where increases in AIDS funding are siphoned away to honest underperformers in a fruitless attempt to bring about “zero tolerance” for fraud. Preventing fraud is good; but saving lives and promoting effective local AIDS programs is better.
Continue reading . . .
GE Sees Potential in Health-Care Unit
Wall Street Journal, 3-23-05
The pharmacogenomics guidelines noted above will help pharmaceutical companies develop better drugs and help the FDA to better gauge the risks and benefits of new treatments. A critical component in making personalized medicine a market reality, however, is diagnostics. Having a targeted drug isn’t any good if you don’t have a relatively cheap, effective way to screen patients for genetic variability in hospitals doctor’s offices.
This is where General Electric comes in. GE is devoting billions of dollars to developing the next generation of diagnostic tests and high-tech drug-development tools, which will help personalized medicine make the leap from the lab bench to the bed side.
GE Healthcare, which invests about $1 billion a year in research and development, believes the gene-based technologies it is developing will be able to identify genetic fingerprints of specific diseases that can predict how the disease will develop. Other GE tools will help physicians understand a patient’s individual genetic profile to predict the patient’s likelihood of developing certain diseases. And new imaging tools will be able to show in a matter of days, instead of weeks and months, whether a particular therapy is working.
Finding Medical Destiny on the Family Tree
The New York Times, 3-22-05
The New York Times chronicles one’s family’s struggle to weigh the benefits (and drawbacks) of genetic testing when there is a familial history of breast and ovarian cancer. Genetic testing, or what is called “predisposition analysis” for cancer is only in the very early stages - according to one researcher “only about 5 to 10 percent of breast cancers can be attributed to” mutations on the BRCA gene (BRCA1 and BRCA2). However, carriers of these genes face a cancer risk that is substantially higher than the general population: “Estimates are that BRCA1 implies a lifetime risk in the range of 50 to 80 percent, and BRCA2 about 40 to 70 percent.” Still, some people with the genes may never get cancer, and some people without them will still develop breast cancer.
Every woman who may be at high risk of breast cancer will have to struggle with whether or not to be tested—and what to do if the test is positive. In general, though, genetic tests like these are bringing us “closer to the day when there will be no more general treatment for breast cancer, only a treatment developed to combat or prevent, a specific breast lesion in a specific individual.” The drug Herceptin (a breast cancer drug) is only given , for instance, to patients whose breast cancer tests positive for a specific protein, called HER/neu. Herceptin is a “targeted” treatment which only attacks cancer cells with this protein, and thus has significantly fewer side-effects than traditional chemotherapy. As genetic tests gain in precision and availability, targeted cancer treatments will follow the Herceptin model - becoming ever more tailored, effective, and safe.
IVAX: The inside story of how a drug is developed
The Miami Herald, 3-21-05
The Miami Herald has a must-read article on drug development this week.
Drug development is a multi-million dollar gamble. “Only one in five drugs that start human clinical trials reach market” - and each of the many other failed “bets” on new medicines has its own costs. Estimates of the costs of drug development vary, but one widely quoted figure (taking into account the cost of capital and the high rate of failure) is $800 million.
The company described in this article, IVAX, spent $140 million on R&D last year, but only a tiny fraction of compounds in their drug development pipeline will ever become profitable - and even those drugs that eventually reach consumers won’t do so for a decade or more.
Companies like IVAX are taking enormous gambles with enormous stakes. The payoff has to compensate them for their risks.
ACCELR8 ADAPTS TO STRAINS IN MARKET; NEW PRODUCT AIMS TO SAVE LIVES, SLOW ANTIBIOTIC RESISTANCE
Rocky Mountain News, 3-21-05
This article, from the Rocky Mountain News, raises an issue briefly discussed last week: direct-to-consumer advertising for prescription drugs.
RMN says that, “amid rising criticism of direct-to-consumer prescription drug ads, Johnson and Johnson is unveiling a new approach to TV and print campaigns that deals head-on with safety, putting drug risks on more equal footing with drug benefits.”
J&J is one of several pharmaceutical companies rethinking its approach to consumer advertising in the wake of the safety risks discovered for Cox-2 drugs, and for Vioxx in particular. Still, the bottom line of any approach to health care is empowering patients to better control their own health care decisions; and advertising (along with other forms of health care information from insurers and government) has real and powerful, if under appreciated, benefits for consumers.
Roche, Glaxo await OK for easier osteoporosis drug.
Reuters News, 3-18-05
Reuters reports on a new “once-monthly osteoporosis pill [that] could be good news for sufferers of the brittle bone disease.” The FDA is currently slated to rule on Roche/Glaxo’s application for the drug, called Boniva, on March 26, in just a few days.
Boniva may turn out to be a more convenient treatment for patients, since current treatments “have to be taken in the morning on an empty stomach and patients must remain upright for 30 to 45 minutes.”
Other companies are working on drugs that would require even less frequent dosing, from every three months to perhaps only once a year.
“Osteoporosis, which causes a loss in bone mass, is most common in older women after the menopause when levels of the female hormone estrogen drop. It occurs in about one in three elderly women and one in 12 older men.”
Eminent Domain Urged As Tool to Cut Drug Costs
Washington Post, 3-17-05
There is a proposal in the District of Columbia, according to The Washington Post, to have the city use “one of the government’s traditional powers [eminent domain]” to seize drug patents and transfer them to generic companies to produce the drugs the city buys for its public health care programs like Medicaid.
The Post says that “the issue propelling the bill is the skyrocketing expense of brand-name drugs. The country’s spending on prescription medicines has more than quadrupled since 1990, according to the Kaiser Family Foundation, and is on track to maintain double-digit increases annually through 2013.”
We would add that most of the increase in U.S. prescription drug spending is due not to drug-price inflation but to increased utilization of prescription drugs. In other words, drugs are enormously valuable medical tools, and we’re using more of them. If D.C. lashes out at pharmaceutical companies, by breaking patents, it will be cutting off its nose to spite its face.
Company spent nearly 18 years developing drug; Amylin diabetes drug wins FDA approval - It's first new treatment since insulin introduced
The San Diego Union-Tribune, 3-17-05
As a side bar to the San Francisco Chronicle
article on IVAX we discussed above, here is an article on another company’s tortuous odyssey to FDA approval for a new diabetes drug called Symlin.
Amylin Pharmaceuticals said yesterday that federal regulators have approved the use of its drug Symlin to treat diabetes, capping a drug development process that began almost 18 years ago. Symlin represents the first new drug for the treatment of diabetes since insulin was introduced in the 1920s. It also is San Diego-based Amylin’s first product to win clearance by the U.S. Food and Drug Administration…Amylin experienced a number of setbacks in its protracted quest to develop a new diabetes drug, which included clinical trials involving more than 5,300 people. The process required the company to raise $1.3 billion.
Until Symlin was approved, Amylin’s investors sunk millions of dollars into the company in the faith that one day - hopefully - they would produce a blockbuster drug. Amylin’s win is a victory both for its investors and for diabetics, who “just don’t get many new drugs.”
State program debuts to assist with medications | Public linked to discounted, free drugs
The San Diego Union-Tribune, 3-17-05
The San Diego Tribune
weighs in on California’s latest attempt to supply affordable prescription drugs to patients who may lack prescription-drug insurance. The plan, Rx Help for Californians, is “a new $10 million program sponsored by the pharmaceutical industry”, and “acts as a clearinghouse, providing individuals with access to more than 350 discount and assistance programs and 2,300 medications.” You can find an early evaluation of Rx Help by Sally Pipes here
Despite the fact that “more than 60 patient and health care advocacy organizations support the program,” Rx Help is already drawing some criticism from consumer advocates who think that the state should “negotiate” directly with pharmaceutical companies for lower prices. “Negotiate” is, of course, just a code for government inflicted price controls. Legislators should carefully consider the impact of price controls on pharmaceutical R&D, and remember that mandating cheap drugs now will rob future patients of access to better medicines.
F.D.A. Issues a Guide to Gathering Genetic Data That May Personalize Drug Therapy
The New York Times, 2-23-05
The key to developing personalized medicine is expanding our understanding of how the most basic building blocks of life - genes - influence disease and how patients respond to different medical treatments.
The FDA has taken a huge step towards making personalized medicine a reality by issuing new “guidelines for pharmaceutical companies intended to encourage them to gather and submit information about how genetic variations affect the way people respond to their drugs.” In the long run, giving companies incentives and guidelines for submitting better genetic data on their drugs and potential patient groups will not only help make drugs safer and more effective, it will allow doctors to prescribe drugs with confidence that they are really giving the right drug, to the right patient, at the right dose to treat and cure disease.
REVIEW & OUTLOOK (Editorial): How About a 'Kianna's Law'?
Wall Street Journal, 3-24-05
The Wall Street Journal
captures one side of the drug safety issue that seldom receives attention outside of industry circles: how the FDA’s obsession with amassing reams of redundant data costs lives.
highlights the predicament of a single kidney-cancer patient who is dying while the FDA denies her access to treatments for her disease.
What makes Mrs. Karnes’s predicament so depressing is that two different developmental drugs have shown great promise for several years now against this once near-untreatable disease. But not only has the Food and Drug Administration not moved with dispatch to approve the drugs, it has begun imposing new testing requirements that make it all but impossible for their developers – Bayer and Pfizer – to provide them to terminal patients on a ‘compassionate use’ basis.”
Commentary: D.C.’s drug problem
Doug Bandow, Washington Times, 3-23-05
Bandow criticizes D.C. city council member David Catania for “pushing the Prescription Drug Compulsory Manufacture License Act”, which would allow D.C. to seize drug patents using the government’s power of eminent domain and award them to generic-drug manufacturers.
The goal: cheap drugs for everyone. After all, drugs are very expensive to research and develop, but the final product - the pill - can be produced very cheaply.
Bandow writes that patients might rejoice
…until they show up at the pharmacy expecting to buy the next generation of lifesaving drugs. The U.S. industry spends about $40 billion a year on drug research and development. Or did, if Mr. Catania gets his way. No company will invest the roughly $800 million that it takes, on average, to create a new medicine if it knows the government can seize the result of its work. There ain’t no such thing as a free lunch, goes the saying.
Health Savings Accounts: The Bright New Stars of Consumer Directed Health Care
Grace-Marie Turner, Galen Institute, 3-21-05
Grace-Marie Turner surveys the field for HSAs and finds some reason for optimism: “438,000 people had purchased HSAs in the first nine months of last year. The study also found that 30 percent of them were previously uninsured. Other studies have found that 40 percent of HAS purchasers make less than $50,000 a year, about one-third of purchasers are families with children, and half are over age 40, showing they have broad appeal.”
Other consumer directed vehicles are helping as well.
HSAs are just one example of a constellation of offering that give consumers more power and control over health care decisions…Employers and health plans are smoothing the way by providing access to existing networks and on-line information tools. They are also instituting new programs to provide better coordinated care for those with chronic conditions, such as diabetes, heart disease, and asthma. Some companies that have replaced their traditional health insurance with a consumer directed plan have seen their health costs fall by more than 10 percent, even as the use of preventive services by workers increased by as much as 23 percent.
Putting Profits ahead of Patients
Dr. Scott Gottlieb, Forbes, 3-17-05
Gottlieb notes that Novartis, “a highly profitable research based [pharmaceutical company]”, has made the decision to “bound into the low-profit commodity generic medicine business” - a move that bodes ill for future patients in need of innovative new drugs.
Novartis, like the handful of remaining major European drug companies, has learned to cope in price-controlled markets abroad while at the same time making enough money in the free U.S. market to support its research mission. It should be little surprise that the only other big branded drug maker with a serious stake in the generic drug industry is the French pharmaceutical firm Sanofi-Aventis. Sanofi enjoys unfettered access to the French generic drug market, where the government sets high prices and has high barriers against competing generic drug makers that want to do business there, protecting homegrown companies like Sanofi at the expense of everyone else.
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