|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 07-19-2004
Move over, cholesterol drugs
The market for statin drugs may see a price war emerging in the near future. A new combination drug is about to be released called Vytorin (a combination of Zocor with a new drug Zetia) which is expected to compete strongly with class-leading Lipitor. Studies have shown that Vytorin can lower cholesterol better than Lipitor, and industry watchers expect it to be less expensive. Another statin drug, Crestor, has shown itself superior to Lipitor in some studies as well. Prices for statin drugs are expected to fall even faster in 2006, when Zocor loses patent protection.
As more research emerges based on head-to-head comparisons among drugs in the same therapeutic class, consumers and doctors should benefit from increased knowledge and lower prices.
Bush Administration Seeks to Clear Confusion About Medicare Cards
There are real concerns that more low-income Medicare beneficiaries need to sign up to receive a drug discount card that entitles them to a $600 subsidy towards the purchase of prescription medications. Mark McClellan, Administrator of the Centers for Medicare and Medicaid Services, has nonetheless lauded the achievements of the program to date: about 4 million seniors have the discount cards and 125,000 are signing up for cards every week. Mr. McClellan has said that his agency is working with civic groups and stepping up its own efforts to recruit low-income seniors into the program. To date, eight pharmaceutical companies have promised to continue to offer low-income seniors prescription drugs for little or no cost even after the $600 subsidy has been exhausted. Election year criticism not-withstanding, policymakers should focus on helping the program become even more successful, rather than carping about what it hasn't done yet - two months into its existence.
US FDA to revise drug review letters
In another sign that the FDA is focused on real reform efforts, the agency is aiming to provide companies whose drug applications are turned down better explanations as to why their applications failed. Under a recently released proposal, the agency would replace its two drug review letters, "approvable" and "not approvable", with a single "complete response letter" that will give companies a specific catalogue of steps that applicants must follow to win drug approval.
As companies get a better sense of what the agency expects, they can retrofit their programs to better comply with expectations. Patients are, in the final analysis, the winners in this scenario. A large component of drug prices are the innumerable failures that precede even a single successful drug launch. Cutting down the failure rate by even 10% would lower prices significantly.
Study of Antidepressants Finds Little Disparity in Suicide Risk
A study of nearly 160,000 British patients treated for severe depression in the Journal of the American Medical Association found that there is no real difference in rates of suicidal behavior among patients given one of three commonly prescribed antidepressants: Paxil, Prozac, or the generic amitriptyline.
The study is welcome news for physicians and patients who were concerned by recent reports that certain antidepressants might present an increased risk of suicidal tendencies among adolescents. The study confirmed what physicians had long suspected: suicide risk is highest when patients first begin drug treatment for depression, and then declines rapidly.
Investors Target The Side Effects Of Cancer Drugs
New targeted cancer drugs are helping to save lives without many of the debillitating side effects associated with earlier forms of radiation and chemotherapy. Still, hundreds of thousands of cancer patients every year are afflicted by side-effects of cancer treatments, including oral mucositis, a condition which affects about 40 percent of patients undergoing chemotherapy or radiation therapy. Oral mucositis is a painful condition where sores in the mouth make speaking, eating, and drinking difficult or even impossible. Side-effects from cancer treatment can become so severe that treatment has to be halted altogether.
Large pharmaceutical companies have been hesitant to develop therapies for conditions like this, which may only afflict a minority of cancer patients. Thankfully, small start-up venture capital biotech firms see an opportunity here both to make a difference in cancer patients' lives, and carve out a profitable niche for their products. One company, Aesgen, has developed a drug to prevent oral mucositis and accelerate healing; a marketing application for the drug, Saforis, should be filed with the FDA this year.
Still, for smaller firms to expand their effectiveness in niche markets, the FDA should make its drug approval process as cost-effective as possible, so that drug development costs don't hinder venture capital firms from developing effective treatments for relatively small groups of patients.
Coalition Floats Ideas to Tame Rocketing Costs of Health Care
The National Coalition on Health Care, a nonpartisan group representing companies, unions, consumer groups, and politicians, is calling for the establishment of a national board overseen by Congress that would "set limits for reimbursement rates paid to physicians and hospitals for a set package of core medical benefits and restrict increases to insurance premiums." The group also called for setting quality standards and technology improvements to further reduce costs.
It is not clear that a national price control board for health care would do much to control rising costs - the U.S. may lead the world in overall health care spending, but other developed nations are not far behind. For instance, since 1970, according the Center for Studying Health System Change, the average annual growth in U.S. health care spending was 4.4 percent; the average for other wealthy countries was 4 percent.
And if rich countries where governments largely set prices for health care can't significantly lower the rate of spending increases, what is the point of the U.S. switching to a single-payer model? Proponents of the U.S. adopting European-style health care should also take note of the fact that just as the U.S. is increasing government control of health care, Europeans are trying to find ways to reduce it. Installing a price control board for health care would just be a bad first step in the wrong direction.
US drug imports rising despite warnings, FDA says.
According to government officials, "thousands of packages" containing imported prescription drugs enter the U.S. every year, and it is "impossible for border inspectors to check most of them." A flood of cheaper prescription medications may seem like a boon to U.S. consumers, but safety concerns cannot be breezily waived aside, as many industry critics would like. According to one FDA official, "personal importation can never be made safe and effective." Drug importation, however, will happen if policymakers fail to make the case that market driven innovation and improvement of the drug discovery process are not better alternatives than importing Canadian (or European) price controls.
In a Shift, Bush Moves to Block Medical Suits
Asking local juries to conscientiously sift through mountains of complex scientific evidence (that has already been reviewed by experts at the FDA) in the emotionally fraught confines of a court room is asking the tort system to bear a responsibility it is not designed for.
The FDA already has an extensive mechanism for reviewing the safety and efficacy of drugs, and can review evidence from industry, consumer groups, physicians, and policymakers both before and after a drug has been approved for marketing. The FDA's stance on federal pre-emption of tort claims underscores the reality that a single devastating judgment against a drug or device manufacturer could remove an otherwise life-saving device from the market and weaken the broader financial incentives driving medical innovation. For more on this important issue see Robert Goldberg's The Sacking of Troy and Robert Pollack’s Dems Win Round One in Hinchey V. Troy.
When, last week, the government issued recommendations that patients at high or moderate risk of heart attack lower their LDL or "bad" cholesterol to new, lower levels, people who were already being treated for elevated cholesterol levels undoubtedly took note. But what about Americans who have little time or patience for doctor's visits and have no idea what their cholesterol score is? After all, until you know what your own heart disease risk profile is, you won't take steps to monitor or control your cholesterol levels.
This may change in the near future as an increasing number of relatively inexpensive and sophisticated self-testing kits become available to Americans for ailments ranging from high cholesterol to hepatitis C, HIV, colon cancer, and allergies. While these products are designed to "calm fears and assist doctors", they can also make it easier for physicians and patients to monitor whether or not prescription drugs, once taken, are really as effective as they are purported to be. All-in-all, tests like these put more knowledge in the hands of consumers to better guide their health care decisions.
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