|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 03-21-2005
IVAX: The inside story of how a drug is developed
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
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.
Finding Medical Destiny on the Family Tree
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.
GE Sees Potential in Health-Care Unit
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.
India Adopts Patent Law Covering Pharmaceuticals
India recently passed legislation which allows drug compounds to be patented for the first time; “previously, only the process of making the drug was patentable.” Critics of the law are already saying it is a devastating blow to developing countries in need of inexpensive generics, since India is one of the world’s leading producers. According to one generic company’s spokesperson: “The passage of the patent bill, for me personally and for India as a whole, is a very tragic and a very sad day…It will be the start of a predictable, long term tragedy for the country.”
This jeremiad seems like a gross exaggeration. India produces cheap generics not only because it can avoid the expensive R&D that burdens research pharmaceutical companies, but also because it has a low-cost, highly skilled labor force. Most of the drugs that are off patent will remain off patent, and those medicines will stay cheap. Conversely, India’s competition with established pharmaceutical companies in the U.S. and Europe will help spur innovation and drive down prices, since Indian companies can use their lower capital costs to pioneer new medicines at a fraction of the cost. More innovative drugs at lower prices is a win-win scenario for rich and poor nations alike.
The Campaign for Fighting diseases (www.fightingdiseases.org) also points out that patents are not the primary barrier keeping poor countries from accessing needed medicines.
A study by Amir Attaran has shown that in 65 low- and middle income countries, where four billion people live, patenting is rare for the 319 products on the World Health Organization’s Model List of Essential Medicines. Only seventeen essential medicines on the list are on patent in any of the countries, so that overall patent incidence is low (1.4 percent) and concentrated in larger markets…many companies choose not to enforce their patents in certain lower-income countries. Of the 969 cases surveyed by Attaran where companies probably could have obtained and maintained patents for these essential medicines, they did so only 31 percent of the time.
In other words, companies don’t patent drugs in countries that are too poor to pay for them in the first place. Activists want more medicines available in poor countries and attack intellectual property rights in order to bludgeon companies into supporting the activists’ agenda. In the long run, however, undermining support for R&D by attacking patents will inhibit innovation as investors become afraid that new medicines will be compulsorily licensed by governments (like Brazil) or international agencies that want to cure diseases without paying the full cost of the cure.
New Vaccine Said to Offer Hope Against Bacterium
The most feared—and best known—diseases are not always the biggest killers. More prosaic maladies often inflict more suffering and death in developing countries than headline-grabbing ailments like AIDS and Malaria. Take, for instance, the Streptococcus pneumoniae bacterium, which kills thousands of children every year in Africa. A vaccine for this disease has been available in the U.S. for infants since 2000. The vaccine, called Prevnar, prevents “rare but serious infections” from the bacterium; a stronger version just finished clinical trials in Africa.
In the third world, the same germ is a major killer, and the new vaccine, tested in Gambia, “exceeded our expectations,” said Dr. Orin Levine, head of the pneumonia program at the Global Alliance for Vaccines and Immunization, which backed the trial. “Most people don’t know it, but pneumoccocal disease kills more people every year than malaria. In this trial we prevented one death for every 200 children we vaccinated. That’s a whopping public-health contribution.”
Wyeth, the company that developed the vaccine, is “negotiating a price for standard Prevnar with the Gambian government and would work with GAVI in the future on the strengthened vaccine.” The new vaccine, however, doesn’t come cheaply: the trial for the vaccine tested in Gambia involved some 17,000 children and cost $30 million. While citizens in developed countries complain about the high price of medicines, sales of drugs in the first world subsidize cheaper prices in developing nations. For instance, a vaccine “used in poor countries that protects against diptheria, tetanus, whooping cough, hepatitis B and heamophilius influenza B in one shot is purchased by the Global Alliance for $3.65 a dose, a fraction of what similar shots cost in the West.” Policymakers in the U.S. should consider this reality the next time ideologues demand price controls here.
Back from the brink | Millionaire father rescues company; knew drug would help his daughter
Allen Andersson is an “angel investor” who saved the drug company Amylin Pharmaceuticals from bankruptcy by investing millions of dollars of his own wealth when the FDA rejected the application for its flagship drug. Last week, the drug was finally approved and “Amylin pharmaceuticals…credits Andersson with keeping Symlin alive for the six years it needed to obtain FDA approval.” The root of Andersson’s passion: his daughter, Rachel, is a diabetic. Amylin’s drug, Symlin, is the first new diabetes drug in about 80 years.
Amylin’s trouble started when it submitted the results of two late stage (Phase III) clinical trials to the FDA in 1999.
The FDA said the results were “statistically insignificant,” meaning that the results could not conclusively prove that the drug’s success was not due to chance. Wall Street’s reaction was unfavorable. Amylin shares took a dive…Andersson looked at the same statistics with the eyes of a mathematician and concerned father. “Anyone with an understanding of diabetics or statistics could see this was a good drug that did the job and was safe and effective,” he said.
Still, it is sobering to remember that the hopes of thousands of patients can hinge on the generosity and faith of a single investor—who sees something FDA’s statisticians can’t.
Your mother always told you to eat your green vegetables. She didn’t know how right she was. Today, scientists are testing whether or not a key mineral (magnesium sulfate) found in most leafy green vegetables can be injected into stroke victims to help save brain cells in the first crucial hours after an attack. The effort is focused in Los Angeles County, which is launching a large, ambitious clinical trial involving paramedics and thousands of patients.
Los Angeles County paramedics in mid-January started screening patients for participation in the planned three year study, which would allow emergency personnel to administer a specially prescribed solution to patients being transported to any hospital in the county for further treatment….The treatment under study is called “Fast-Mag,” named for magnesium sulfate. Researchers believe this mineral might slow the chemical process that can kill 12 million brain cells per minute during an untreated stroke, leading to long-term disability and death.
The study will also be groundbreaking because the “the sheer scale and diversity of the population that lies within [Los Angeles County] could establish its findings quickly as relevant across the country—and possibly the world.”
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