|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 04-20-2005
Merck to Discount Drugs for Uninsured; Prices to Compare to Canadian Imports
We have several articles this week that touch on issues surrounding drug pricing (including this one) and importation (including an op-ed by Elizabeth Whelan).
Merck has announced that it will
…provide uninsured Americans steep discounts on many of its prescription medicines, joining other pharmaceutical firms in slashing some prices during debate over importing drugs from Canada…For instance, Merck will discount Fosamax, its popular treatment for osteoporosis, by 22 percent…
In response Ron Pollack, executive director of Families USA, a liberal health-policy group, said that “uninsured people are often unable to go to a physician because they can’t afford to pay…Therefore they can’t even get a prescription.”
Pollack’s remark highlights the misleading nature of our national debate over importing drugs from Canada. The argument in favor of importation hinges on the fact that some Americans lack health insurance coverage—for prescription drugs or anything else.
Drug pricing, in other words, is a red herring used to bash industry. After all, if prices are the problem, why not demand that hospitals lower their prices to the point where poor Americans without insurance can afford heart bypass surgery?
Merk’s program is laudable, but they cannot offer the health care coverage poor Americans need, and we shouldn’t expect them to.
THE NATION; Former FDA Chief Backs Drug Import Plan; The proposal would protect consumers from substandard and counterfeit medicines, Dr. David Kessler tells a Senate committee.
Former FDA Commissioner David Kessler has endorsed legislation by Senators Byron Dorgan and Olympia Snowe that would legalize commercial importation from over 20 countries, including Canada and many EU member states. During his Congressional testimony supporting the legislation Kessler told the senators that
“The choice before you is not the choice of imports or no imports…The American public will be safer with a regulated system than with the current system of uncontrollable risk.”
Kessler argues, in short, that drug importation is so dangerous now that we should make it a national policy. Presumably, federal regulations and FDA inspectors would protect Americans from the risks that individual consumers now bear.
This is a very dubious argument. Drugs shipped from many foreign countries would have to be repackaged and relabeled with English instructions. This would make guaranteed sourcing of imported drugs nearly impossible. Graham Satchwell, a member of the United Kingdom’s Government’s Patent Office Investigative Strategy Group, testified at the same hearing. He noted that
The truth is that counterfeit medicines often appear so like the genuine product that no one, not the best specialist can tell the genuine packaging from the counterfeit…unless the product is subjected to chemical analysis. The result is that everyone, poor, ignorant, rich and smart, all are at risk from counterfeit or sub-standard products…
If a pair of fake Nike sneakers are imported into the U.S. no one will perish from wearing them. If Congress opens the U.S. market to large-scale importation of substandard or dangerous drugs, people will die.
Patients are increasingly objecting the FDA’s role as consumer surrogate.
Although it’s under pressure from Congress to be more diligent about policing serious drug side effects, the FDA is also besieged by patients eager to take such risks. Besides visits from silicone-implant proponents, FDA panels have recently heard from patients who want Cox-2 arthritis drugs such as Celebrex or Vioxx, which can hike the risk of heart disease, because they think the drugs are the only way to ease their pain…Such lobbying puts patients at odds with watchdog organizations meant to look after their interests.
The FDA’s role as “watchdog,” in short, is being challenged by technological and social developments that empower patients rapidly and effectively. This is a win-win situation for the FDA and its stakeholders. Improvements in health care markets, like any others, are best led by savvy consumers. The FDA can accelerate this trend by shifting its focus to being a better market educator.
20 arrested in crackdown on Internet drug pipeline
Federal agents broke up a $6 million online smuggling ring yesterday that peddled drugs to tens of thousands of people, mostly teenagers, through at least 20 different Web sites.
These arrests highlight how difficult it is for law enforcement and federal regulators to monitor drug imports. Drug Enforcement Administration Administrator Karen Tandy said that
Today is every parent's nightmare…The Internet has become an open medicine cabinet. Strangers are peddling drugs in your home, and you don't even know it. There is no visit to a doctor, no pharmacist to vouch for the integrity of the medication and no prescription.
Legalizing commercial importation, as Congress is now considering, would only expand opportunities for fraud, counterfeit drug smuggling, and place more American lives at risk. As U.S. Attorney Patrick Meehan notes, "All you need is a keyboard and a credit card and you're able to order drugs like codeine, ketamine [a popular club drug] and steroids."
Ariad gets FDA cancer drug fast track
While researchers have been making enormous strides in many areas of cancer research and treatment, there are still no effective drug treatments for sarcoma, a type of highly aggressive cancer that attacks bones or soft tissue. Each year 12,000 persons are diagnosed with the disease. Fewer than 15% of patients with metastatic sarcoma survive five years after diagnosis.
Recognizing the need for better sarcoma treatment, the FDA has given Ariad Pharmaceuticals a fast-track designation for its experimental cancer drug, AP23573.
Dr. Harvey Berger, Ariad's chief executive, said that with the accelerated timetable made possible by fast-track designation, the firm might seek final approval for the drug as early as next year, even though another round of clinical trials remains to be completed. The designation means the firm will work more closely with regulators, and may be able to design a final trial with an end point that is easier to reach quickly. …Berger said that compared to traditional chemotherapy drugs, Ariad's experimental treatment has an extraordinarily low incidence of side effects.
As the saying goes, time is money, but when it comes to cancer, time is counted in lives lost before treatments reach the market. Fast track and accelerated approval are needed to expedite new treatments like AP23573 to patients with life threatening diseases.
A ripple effect for painkillers
When it comes to drug safety, everything is truly relative. Pulling nonsteroidal anti-inflammatory painkilling drugs like Vioxx off the market may make sense if we have other painkillers available that are safer for that use. But what if those drugs, which carry a small risk of heart problems for some patients, can have large postive effect on patients at high risk of cancer prevention?
The discovery of a potential cardiovascular risk [for Cox-2 drugs like Vioxx] comes at a time when nonsteroidals have moved into the forefront of [cancer] chemoprevention research. Years of animal studies and observational studies showed the drugs seemed to prevent cancer. Drug companies making nonsteroidal drugs may back away from cancer prevention studies, said Dr. Raymond DuBois, a professor of molecular oncology at Vanderbilt University Medical Center in Nashville. "One of the issues is that when you do a large trial like this they cost upwards of hundreds of thousands of dollars," he said. "They are not going to invest that kind of money when it leads to a negative image."
Halting market access to a promising drug is no way to encourage medical innovation. Hopefully, further research on personalized medicine will help identify which NSAIDs and Cox-2 drugs can be used safely in which patients, allowing research to more forward.
Breast Cancer Recurrence Is Cut in Half by a Drug
Herceptin is a targted cancer drug designed to treat the approximately 25 percent of women whose breast cancer has a particular genetic mutation, so-called HER2 positive. Initially, the drug was only approved to treat late-stage cancer, in combination with chemotherapy. A recent study, however, has shown that it reduces recurrence in women whose cancer was caught early by 52 percent compared to chemotherapy alone.
The two trials, which began enrolling patients in 2000, involved a combined total of more than 5,000 women, though the analysis that resulted in the trials' being stopped was based on only 3,300 of them. All were so-called HER2 positive, a reference to the genetic characteristic of the tumors that makes a patient a candidate for Herceptin. All had operable cancer that in most cases had spread to the lymph nodes. All patients were given chemotherapy, and some were also given Herceptin. Dr. Clifford A. Hudis, chief of breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York, called the results ''big news'' because using the drug in early-stage treatment could have an impact on a greater number of women and perhaps help keep them free of cancer.
Number of Uninsured May Be Overstated, Studies Suggest
Health insurance—and the lack thereof—is a hot topic for Washington policymakers. Every few months, it seems, we hear a sermon on the rising number of uninsured. The most recent estimate of 45 million uninsured Americans, however, may be significantly inflated.
Four government surveys attempt to estimate the number of Americans who are without coverage for a full year. The results range from a high of 45 million in the Current Population Survey to a low of 19 million… ."There is an undercount of Medicaid coverage," said Charles T. Nelson, the census official. "We are looking at ways of improving our estimate so people covered by Medicaid report. There are people with coverage out there who are not reporting coverage."
There are still, of course, millions of uninsured Americans. But any rush to expand government coverage could drive private insurers out of the market, and exacerbate the problem.
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