|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 03-12-2007
Ex-Chief Urges FDA to Mine Databases
Associated Press, 3-12-07
Former FDA Commissioner and CMS Administrator Mark McClellan spoke at an Institute of Medicine meeting this week and encouraged the FDA to mine databases held by private insurers to help detect safety signals associated with prescription drugs.
He also pointed out that cardiovascular concerns associated with Vioxx "could have been detected in months rather than years" if the FDA had access to this type of realtime, active safety surveillance.
Former agency chief Dr. Mark McClellan said Monday that the FDA should make more use of the pooled information contained in large healthcare databases, like those run by private insurers that include information about 100 million Americans.
He said the FDA should make more use of the pooled information contained in large healthcare databases, like those run by private insurers that include information about 100 million Americans.
That surveillance, for problems like the increased risk of heart attack and stroke that led to the withdrawal of the popular painkiller Vioxx in 2004, could broaden the FDA's view of drug safety problems as they emerge while respecting patient confidentiality, he said.
McClellan spoke during an Institute of Medicine symposium on the drug safety challenges the FDA faces...
The FDA already has begun to tap into large private and public healthcare databases, collaborating for instance with the Department of Veterans Affairs, the agency's Dr. Gerald Dal Pan told the symposium. But the cash-strapped FDA still needs more epidemiologists and computer programmers to do the work, he added.
In other words, the question now is whether Congress (through PDUFA reauthorization) will give the FDA sufficient funding to make the agency's vision of a postmarket monitoring a reality. Stay tuned.
High Deductibles cut down on emergency room visits
Boston Herald, 3-13-07
Advocates of highdeductible health plans have long argued that such plans encourage consumers to economize on their use of the health care system, allowing purchasers of such plans to benefit from lower premiums and slowing the rate of health care inflation. The week, a new Harvard Medical School study found evidence to support this argument, showing that consumers with HDHPs reduced their use of hospital emergency rooms for minor ailments.
The study, published in the Journal of the American Medical Association by Harvard Medical School and HarvardPilgrim Health Care, found that patients with high deductibles sought emergency room treatment 10 percent less than patients with traditional plans.
Many highdeductible patients stayed home instead of seeking treatment for less severe conditions like colds, nausea and headaches, the study found. Researchers followed patients with high deductible plans for one year after they switched from traditional plans with lower deductibles, but higher monthly premiums.
"Our study showed that for most members, the highdeductible plan seemed to work as intended," said Dr. Frank Wharam, the study's lead author. "Patients went to the emergency room less frequently for nonemergency conditions."
The researchers said more studies are needed to ensure that highdeductible patients are not neglecting medical emergencies because of the high cost of hospital visits.
Low cost health plans, with high deductibles to offset some of the expense of the discounted monthly premiums, play a central role in Massachusetts' health care reform law.
Cancer burden expected to soar, overwhelm doctors
USA Today, 3-13-07
First the good news: Americans are living longer than ever before, and we are getting better at detecting, treating, and curing cancer. Now, for the bad news: Americans are living longer than ever before, and we are getting better at detecting, treating, and curing cancer.
The graying of America will swell the number of cancer patients and survivors 55% by 2020, according to a study that suggests doctors may not be able to cope with the additional burden.
The analysis, published online Tuesday in the Journal of Oncology Practice, says the number of Americans who are diagnosed with cancerboth those in treatment and those who have finished therapywill grow to 18.2 million, up from 11.7 million in 2005. Today, about one in 26 Americans have had cancer. By 2020, roughly one in 19 will have been diagnosed with the disease, says Edward Salsberg, an author of the study from the Association of American Medical Colleges' Center for Workforce Studies. Researchers based their analysis on data from the National Cancer Institute.
The study's authors note that the increase in cancera disease of agingparallels the growth in the number of Americans over 65. Patients also are living longer after a cancer diagnosis because of early detection and better treatments, Salsberg says.
There may not be enough doctors and nurses to care for so many sick people, Salsberg says.
Color us skeptical. Cancer survivors today are much more likely to be healthy and productive after they are treated than patients just a few years ago. As the detection of early stage cancer improves, and new treatments come online, the postdiagnosis/treatment burden on the health care system is much more likely to decline than it is to grow. We're expecting that this study will turn out to be a worstcase scenario that never pans out.
Pediatric Study Costs Rose Substantially from 2000 as Complexity Grew
Tufts Center for the Study of Drug Development, 3-13-07
Tufts researchers announced this week that, although the cost of drug companies' studies of their medicines in pediatric populations has soared, it hasn't slowed pediatric research thanks to an FDA program that rewards companies with 6 month patent extensions in return for studying selected medicines in children.
The average cost to complete pediatric research on already marketed prescription drugs, in response to a request from the U.S. Food and Drug Administration (FDA), increased nearly eight times between 2000 and 2006, according to findings released today by the Tufts Center for the Study of Drug Development.
The increase, in nominal dollars, from $3.93 million in 2000 to $30.82 million in 2006, is consistent with the general increase in cost, length, and complexity for developing new drugs, Tufts CSDD said.
The analysis also found that during the first 10 years of an FDA program that seeks to encourage pediatric research, such studies have been undertaken on more than 100 diseases and conditions and have led to new labeling for 120 new or already approved drugs for use in children.
"While the cost to complete pediatric studies has soared, drug companies are not letting that get in their way," said Tufts CSDD Associate Director Christopher Milne. "The Best Pharmaceuticals for Children Act seems to be doing its job, which is to generate more pediatric studies. The bottom line is that better prescribing information and more formulations are being developed for children."
To improve U.S. labeling of prescription drugs for children, the FDA since 1998 has managed a program in which it asks pharmaceutical companies to conduct pediatric studies on marketed products in exchange for six additional months of market protection, known as pediatric exclusivity, for all of its products that contain the active ingredient being studied. The Best Pharmaceuticals for Children Act, which authorizes this program, is due for renewal in October.
Abbott Escalates Thai Patent RiftFirm Pulls Plans to Offer New Drugs In Spat With Regime
Wall Street Journal, 3-14-07
Beginning last November, Thailand's militaryappointed government has issued compulsory licenses for three patented drugs (two AIDS medicines and one for cardiovascular disease) and signaled its intention to issue similar licenses for many more.
The move comes as Thailand's government attempts to expand access to free health care programs without incurring additional budget costs.
In response to the government's seizure of the patent for its AIDS drug Kaletra, Abbott Laboratories has announced that that it will not market any new drugs in the country.
A decision by Abbott Laboratories not to launch any new medicines in Thailand raises the stakes in a growing battle over patents between multinational drug companies and the country's militaryinstalled government.
The unusual tactic also puts Abbott in the awkward position of refusing to sell drugs for sick people in Thailand in order to protest the actions of the country's government.
The drug maker said it has withdrawn its drug applications from the governmentreview process after the government revoked the company's patent for its blockbuster AIDS medication. Abbott has no plans to stop selling drugs that are on the market.
The Thai government, which took power following a military coup last year, said in January that it would suspend patent protections for two drugs in order to make them more widely available to patients who need them. These were the AIDS treatment Kaletra, made by Abbott, based in Abbott Park, Ill., and Plavix, a bloodthinning drug originally developed by SanofiAventis SA, of France, and comarketed in several countries by New Yorkbased BristolMyers Squibb Co.
In certain situations, including national emergencies, World Trade Organization rules allow a government to unilaterally make or sell patented drugs without the permission of the drug companies. However, pharmaceutical companies have criticized Thailand for stretching the scope of those rules.
Because the Thai government "decided not to support innovation by breaking the patents, Abbott will not submit applications or register new medicines and will withdraw current applications in Thailand until the government changes its position," said Jennifer Smoter, a spokeswoman for Abbott.
Abbott's decision is, to be sure, a controversial one. However, the Thai government has brought this on itself by failing to first negotiate with the drug maker in good faith. Hopefully, the Thai government and the affected companies will find a way to resolve this crisis so as to ensure both Thailand's access to new medicines, as well as the company's right to a fair price for their products.
Breast Cancer Drug Wins FDA Approval
Wall Street Journal, 3-14-07
Earlier this week, the FDA approved a new targeted drug for HER2 positive breast cancers. The drug is labeled for use in patients whose disease has failed to respond to an existing HER2 drug, Herceptin. Both drugs combat a cancer mutation prevalent in about 25% of all breast cancers.
Tykerb, which analysts expect to reach blockbuster status with $1 billion in annual sales by 2010, was approved as part of the FDA's priorityreview mechanism. That means a drug is reviewed in six months rather than 10 months; this process is usually reserved for drugs the agency deems a "significant improvement" to existing treatments.
Tykerb works by inhibiting two proteins involved with cancer growth, the HER2 protein and another one, known as EGFR. Herceptin is administered intravenously in a doctor's office once a week and is designed to inhibit HER2.
Tykerb is a small molecule that can enter a cell to block its proteins, while Herceptin is considered a large molecule that targets HER2 on the outside of the cell.
The British company said the drug would be available in about two weeks.
Glaxo is studying the drug for treating earlierstage breast cancer as well as for use in certain other cancers such as head and neck.
A company spokeswoman said Tykerb will cost about $2,900 a month.
She said that the drug will be included in part of an expanded access program that will make it free to those without health insurance or have an income at or less than 500% of the federal poverty level, which would be $68,450 for a family of two.
What is particularly interesting about this drug is that the company also seems to have thought very carefully about the high cost of new cancer treatments, which is generating something of a backlash among patient advocacy groups and on Capitol Hill. Glaxo's expanded access program will certainly help protect Tykerb from charges of pricegouging.
European agency backs new drug testing ideas
Reuters News, 3-29-07
American and European regulators recognize that it is vital to improve the science of drug developmentto find new ways of bringing safer and more effective medicines to market faster and more cheaply than is possible using current technologies.
The FDA's initiative in this area, called the Critical Path, currently has several million dollars in federal funding. The European Medicines Agency is proposing to spend several hundred million dollars on a similar initiative.
Novel approaches to testing drugs could get new treatments to patients faster and more cheaply than the existing system, according to the head of the European Medicines Agency.
"We have to use the rapid developments in science to see if we can change the way we develop new medicines," Thomas Lonngren said in an interview.
The European Union's planned 200 million-euros-a-year ($267 million) Innovative Medicine Initiative could play a key role in unblocking bottlenecks in the system and finding smarter ways to assess the safety and efficacy, he added.
The EU scheme mirrors the ongoing Critical Path initiative in the United States, which is also designed to speed drug development through the use of predictive tests that can give an earlier signal as to whether a new drug is likely to work.
"In five or six years this could change quite radically the way new drugs are developed and change the requirements we have for drug development, including how clinical trials are conducted," Lonngren said.
Several large drug companies are already working on ways to overhaul the current system.
Novartis AG is one leading proponent of "adaptive" clinical trials that are changed as they go along. This might involve giving more patients a treatment that seems to be working particularly well or focusing on sub-groups of patients who respond to a drug better than others.
Another possibility could be merging different phases of the traditional three-phase clinical trial process into one study.
European policymakers are undoubtedly aware that they lag behind the U.S. in pharmaceutical and biotech innovation, partly as a result of their restrictive pricing of new medicines. This may be an attempt by the EMEA to help level the playing field and make Europe more attractive to pharma companies by streamlining the drug approval process and lowering drug development costs.
If Congress were serious about improving drug safety and lowering the cost of new medicines, it would prioritize funding of the Critical Pathnot starve the program for funding, which it is currently doing.