|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 12-04-2006
New Scrutiny for Stents
Stentssmall metallic devices used to prop open a patient's arteries in the aftermath of a heart attackare a valuable tool in the treatment of heart disease. But one subset of these devices, called drug coated stents, is being analyzed for their potential to cause blood clotting in a small number of patients.
The tiny latticelike props that keep arteries open and blood flowing freely come under scrutiny this week when the U.S. Food and Drug Administration holds a twoday meeting on drugcoated stents.
Also known as drugeluting stents, the devices arrived on the medical scene with great fanfare in 2003 when they were approved by the FDA.
Now, a spotlight has been trained on coated stents because after three years on the market, doctors are finding that some of the 6 million patients with them worldwide are developing potentially dangerous clots. The FDA will determine whether the stents require further study or added warnings.
Word that clots were associated with drugeluting stents first surfaced in September at an international meeting of cardiologists in Barcelona, Spain. There, researchers presented data showing that clots were occurring as late as three years after coated stents were put in place.
Burt Cohen, director of Angioplasty.org, a consumer advocacy group, said his Web site, which maintains a blog and posts reports about coated stents, has received 90,000 hits a day since September.
Doctors are noticing that patients are paying attention to the news. "It has changed my practice slightly," said Dr. Stephen Green, associate director of the catheterization laboratory at North Shore University Hospital in Manhasset. "But I talk to my patients, and for most of them the drug-coated stent is the stent of choice.
Green, citing federal statistics, estimates that only three to four people per every 1,000 receiving a coated stent will experience latestage clotting.
When risks and benefits between drugcoated stents and the bare metal variety are weighed, Green said, the drugcoated devices still come out looking much better.
We will undoubtedly know more about the relative risks of drug coated stents after the FDA's twoday meeting this week reviews the best available data.
Collapse of a Cholesterol Drug
The New York Times, 12-5-06
This editorial, from the New York Times
, offers praise for a drug company's efforts to develop an innovative new medicine, in this case Pfizer's nowdefunct drug torcetrapib.
Unlike statins, which fight heart disease by lowering the amount of "bad" cholesterol in the blood, torcetrapib was the front-runner in a new class of drugs that try to raise the level of "good" cholesterol. It was precisely the kind of product we want the industry to focus on: not a "me too" drug that marks a merely incremental advance over some existing therapy but a wholly new approach that could spur a huge leap forward in the battle against heart disease.
Alas, in the late stages of clinical testing, an independent monitoring panel found that patients receiving torcetrapib were dying at a higher rate and had more heart problems than patients who did not receive the drug. The panel recommended terminating the trial, and Pfizer promptly did so. It was striking evidence of the importance of independent monitors, who can render a judgment based solely on patient safety without worrying about the financial implications for the manufacturer.
Torcetrapib was earlier found to raise blood pressure, always problematic for a heart patient. If that is what caused the increased mortality, then perhaps similar drugs that don't seem to raise blood pressure might work better. But if there is something intrinsically dangerous about raising good cholesterol, then the whole approach may need to be abandoned. That would be a shame. The drugs that reduce bad cholesterol have revolutionized cardiology but have still left heart disease the nation's No. 1 killer.
The Times should also remember that torcetrapib illustrates an every day occurrence in the industrycompanies suspending the development of oncepromising medicines that later turn out to have unforeseen safety risks or poorer than expected efficacy.
Far from being callously indifferent when it comes to patient safety, companies bend over backwards to eliminate potentially dangerous compounds from their development pipelines. However, since no drug is ever 100% safe, beating up on the industry's safety record is child's playespecially when one overlooks the millions of lives saved every year by new medicines.
High costs send patients overseas for care
Charlotte Observer, 12-10-06
The late economist Albert O. Hirschman wrote a very famous book entitled "Exit, Voice, and Loyalty," explaining how voters and consumers express their unhappiness with bad products and policies. In short, they can put up with it, complain, or leave (exit). More and more Americans are responding to high health care prices in the U.S. by choosing to "exit" and seek health care abroad.
Patients from the Carolinas used to travel to Duke University, Johns Hopkins or the Mayo Clinic for medical care. Today some venture even farther—to far—flung places such as Costa Rica, Thailand, India and Singapore.
Last year, an estimated half–million Americans traveled overseas for medical treatment. It's a growing trend among not only the well–to–do who want tummy tucks and face–lifts, but the working–class uninsured searching for affordable heart surgery, knee replacements and dental work.
Businesses and insurance companies are looking at the potential savings of outsourcing medical care to developing countries where labor costs are low and malpractice suits are almost unheard of.
Two years ago, Howard Staab, a self–employed, uninsured Durham carpenter, chose to travel to India for heart valve surgery. The cost in India was $6,700. At nearby Duke University, the same operation would have cost about $200,000.
Although the phenomenon has been called "medical tourism," Maggi Grace, a friend who accompanied Staab to India, said they weren't looking for an inexpensive, exotic vacation.
"We were fighting for Howard's life," she testified in June before a U.S. Senate committee hearing on the subject. "Howard had to travel across the globe at a time when his heart needed to rest."
Hospitals in India treated 150,000 foreign patients in 2005, according to IndUShealth, a Raleigh company that arranges overseas surgery. Costs for medical care are routinely 70 to 80 percent less in India compared with the United States.
Medical tourism is a welcome development if it leads U.S firms to find ways to win consumers back by offering more efficient health care services.
Democratic plan would require HHS secretary to negotiate drug costs
San Francisco Examiner, 12-11-06
Democrats are floating several proposals for introducing direct government price negotiations into the Medicare drug benefit. The Examiner reports, however, that none of these alternatives envision the federal government competing directly with private insurers.
House Democrats will take the middle ground on the Medicare drug benefit, pushing for government–negotiated prices but stopping short of creating a federal plan to compete with private insurers, a lawmaker said Monday.
Rep. Pete Stark, D–Calif., said a government–run plan would save money but is too ambitious for immediate action.
"That might draw a veto and then get us accused—which I don't mind, but most of my colleagues do—of price–setting and all that... There's a hesitancy to seem too radical," said Stark, a liberal in line to chair the House Ways and Means Committee's health subcommittee.
House Speaker–elect Nancy Pelosi, D–Calif., has included Medicare drug negotiation in her agenda for the party's first 100 legislative hours, but she hasn't offered many details.
"The leadership is going to propose the middle ground and I'm going to support it," Stark said…
Democrats believe that by virtue of its massive purchasing power the federal government could negotiate better prices.
Health and Human Services Secretary Mike Leavitt has criticized the idea as "a surrogate for a much larger issue, which is really government–run health care."
The Manhattan Institute recently released a study by senior fellow Benjamin Zycher on the potential effects of government price negotiations entitled The Human Cost of Federal Price Negotiations: The Medicare Prescription Drug Benefit and Pharmaceutical Innovation. Zycher found that
In the short run, federal price negotiations would allow some consumers to receive medicines at lower prices, or, alternatively, would yield savings for federal taxpayers. The longer-term human costs of government price–negotiation, however, are likely to be large and adverse. This paper estimates that investment in new drug research and development would decline by approximately $10 billion per year. It estimates as well the effect of reduced pharmaceutical R & D investment on American life expectancies, or expected "life–years". Specifically, this work projects that federal price negotiations would yield a loss of 5 million expected life–years annually, an adverse effect that can be valued conservatively at about $500 billion per year, an amount far in excess of total annual U.S. spending on pharmaceuticals.
In light of Zycher's findings, Congress should carefully weigh the benefits of cheaper drugs in the short run, with significantly less innovation in the future. We hope that this issue will receive the debate it deserves when Congress reconvenes in January.
FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs
FDA News, 12-11-06
This week the FDA proposed new regulations that clarify when patients with lifethreatening illnesses can access experimental medicines outside of the confines of traditional clinical trials or "compassionate use" programs. This move may be in response to a flurry of criticism and litigation over the last several years.
The Food and Drug Administration (FDA) today proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and to clarify the circumstances and the costs for which a manufacturer can charge for an experimental drug.
Under the proposed rule, expanded access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
"This proposed reform is carefully designed to balance several objectives," said Dr. Andrew C. von Eschenbach, Acting FDA Commissioner. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."
"FDA hopes this proposal will increase awareness in the healthcare community of the range of options available for obtaining experimental drugs for seriously ill patients," added Dr. Janet Woodcock, FDA's Deputy Commissioner for Operations. "By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them."
FDA has allowed many types of access to experimental therapies since the 1970's. Some of the larger programs, including those under the treatment IND (Investigational New Drug) regulations, were successful in enabling tens of thousands of patients with HIV/AIDS, cancer and cardiovascular diseases to receive promising therapies before the products were approved for marketing. However, the existing regulations did not adequately describe the full range of programs available, explicitly recognizing only emergency use for individual patients and widespread treatment use access for large groups of patients. FDA believes it is important that its regulations clearly reflect the full range of treatment use programs available to ensure broad and equitable access to experimental drugs for treatment use. The regulations covering when it is appropriate to charge for an experimental drug need revisions because they fail to account for the full range of circumstances in which charging should be permissible and because they have proven difficult to interpret in practice, resulting in confusion over what costs could be recovered.
The full set of the proposed regulations can be found here.
GOP Lawmakers Add Provision to Passing Tax Package
Washington Post, 12-11-06
In an 11th hour surprise, Congress passed legislation expanding taxdeductible contributions to health savings accounts. This change will help consumers build a larger HSA "nest egg" to cope with future medical expenses.
The provision, which materialized without fanfare late last week inside a massive taxcut measure, expands the amount of money that can be contributed taxfree to health savings accounts (HSAs). The accounts can be used to pay medical bills and for other healthrelated coverage.
The legislation allows anyone to shelter thousands of dollars annually in HSAs, regardless of how much that person pays for a healthinsurance deductible. Current law limits HSA contributions to the amount of a person's deductible. The expansion would cost the government $1 billion in lost tax revenue over the next decade.
Democrats, who will take control of Congress next month, have generally opposed the expansion. But supporters said that House Ways and Means Committee Chairman Bill Thomas (RCalif.) championed it and pressed it through to final approval in the wee hours Saturday morning.
A coalition of highprofile corporate organizations, which pushed for the legislation, spent last week deploying lobbyists across Capitol Hill and urging their members back home to write letters and place phone calls to lawmakers. The U.S. Chamber of Commerce, the National Federation of Independent Business, the American Bankers Association, the Business Roundtable and several insurance companies belonged to the coalition, according to Paul Dennett, vice president for health policy of the American Benefits Council, a leading participant in the group.
Stent Sales Likely to Fall After Meeting
The Boston Globe, 12-11-06
FDA hearings on drugeluting stents concluded this week without major label revisions for the devices, although experts expected their use to be curtailed somewhat.
Late Friday, a panel of medical experts assembled by the Food and Drug Administration said the majority of patients who receive drugcoated stents face a slight risk of blood clots that can cause heart attack and death. However, the panel said there is not enough evidence to tell if the clots are caused by the stents themselves or patients' poor health.
Morgan Stanley analyst Glenn Reicin said the panel's recommendation that stents carry labeling about the safety concerns "will be viewed as acceptable by investors, especially given fears heading into the meeting."
The FDA held the meeting to look at studies suggesting the stents' coatings, which keep arteries from reclogging, can also increase the risk of life-threatening blood clots a year after they are implanted.
The drugreleasing devices marketed by Johnson & Johnson and Boston Scientific Corp. account for nearly 80 percent of all stents currently implanted in the country. Prudential Equity Group analyst Lawrence Biegelsen estimates continued scrutiny could push use of the devices down to 70 percent, as some doctors begin prescribing plain metal stents instead.
Biegelsen said Boston Scientific could be hurt the most by last week's meeting because the FDA indicated it will not raise the submission requirements for competitors looking to enter the drugeluting stent market, which the NatickMass. company currently leads. Last year Boston Scientific made 40 percent of its profits from its Taxus stent.
According to Biegelsen, the meeting played well for Medtronic, which submitted its Endeavor stent to the FDA for approval last month. The company presented threeyear data for the device that showed no instances of the longterm blood clotting problem. Additionally Biegelsen writes that the "panel appeared to be impressed" with the company's plans for an 8,000 patient study comparing the safety of its stent to Johnson & Johnson's Cypher. Medtronic expects the stent to gain approval by mid-2007.