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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 01-31-2007

F.D.A. widens safety reviews of new drugs
The New York Times, 1-31-07

Editor's Notes:

The New York Times discusses the FDA's announcement of broad and significant changes to how it assesses the safety of prescription drugs, both old and new.

The Times frames FDA's efforts as the agency's response to recent scandals involving antidepressants and Vioxx, a pain–relief drug that has been linked to an increased risk of heart problems.

The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.

The F.D.A. plan is the latest effort to fix the agency after a series of missteps. In September 2004, Merck withdrew its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attack. About the same time, the agency announced that antidepressants cause some teenagers to think more about suicide.

In both cases, the agency took years to acknowledge risks to millions of patients that had been apparent to some researchers.

"We don't see this as the only answer," said Dr. Andrew C. von Eschenbach, the F.D.A. commissioner, at a news conference in Washington announcing the initiatives. "It's merely a step as we continue a process of improvement that will be ongoing."

Senator Christopher J. Dodd, Democrat of Connecticut, said in a written statement that far greater changes were needed at the agency. Mr. Dodd promised to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans. The bills' co–author, Senator Charles E. Grassley, Republican of Iowa, has called the agency far too “cozy” with drug makers.

In many cases, the date that the agency will begin the efforts announced yesterday is uncertain. For instance, Dr. Steven Galson, director of the agency's drug center, said at the news conference that the pilot program to assess systematically a drug's safety 18 months after its introduction would probably take about a year to put into place—with the assessment due 18 months after that.

"We're just organizing that process to get started," Dr. Galson said...

Alta Charo, a professor of law and bioethics at the University of Wisconsin and one of the authors of the Institute of Medicine's report, described the F.D.A. announcement yesterday as "a good set of first steps towards improving the safety of the drug supply in the United States."

At the heart of the FDA's new efforts are attempts to improve the underlying science of drug safety, so that industry and the agency can better predict which patients are most likely to get the most benefit from new medicines, or who may be at risk for rare side effects.

Another important effort will be to modernize the FDA's information sharing and data collection capabilities–hopefully leading to the earlier identification of potential safety signals.

What is unclear, however, is how these changes will be greeted in Congress, where critics are already calling for wholesale restructuring of the agency's drug safety programs.

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Drug Industry Faces Bitter Pill: Congress Proposes Tougher Regulation, Cheaper Medications
Wall Street Journal, 2-2-07

Editor's Notes:

In the next few months, Congress will hold hearings on the reauthorization of the Prescription Drug User Fee Act (PDUFA).

PDUFA was first passed in 1992 and sets timetables for the review of new drug applications as well as the fees companies must pay for FDA to review such applications. PDUFA automatically comes up for reauthorization every five years.

While patients' groups, industry, and the FDA have generally lauded PDUFA for helping to standardize and accelerate the approval of new medicines, its funding mechanism (user fees paid to the FDA) has drawn fire from some critics in Congress and elsewhere who allege that the agency is too "cozy" with drug companies.

With the 2008 presidential elections just around the corner, and health care rising as a political issue, PDUFA is likely to become a vehicle for broader health care reforms and additional regulation of the prescription drug industry.

Yesterday, Sen. Edward Kennedy of Massachusetts and Sen. Michael Enzi of Wyoming, the chairman and ranking Republican of the health committee, respectively, introduced legislation that would give the FDA new authority to impose safety requirements on medicines once they go on the market, including restrictions on consumer advertising. The bill also would require registration of clinical drug trials and their results in public databases.

Meanwhile, Sen. Chris Dodd of Connecticut, a Democrat, and Sen. Charles Grassley of Iowa, a Republican, on Wednesday introduced their own drug–safety bills, which would restructure the FDA to create a center to oversee the safety of drugs after they go on the market.

Proposals to beef up regulation have stalled before, often due to skepticism from Republican allies of the industry. This year is likely to be different. Democrats aren't reluctant to give expanded authority to federal regulators and see the drug industry as a tempting target because of its tenuous popularity with consumers and its traditional ties to Republicans. And they're getting support from some Republicans upset by a series of high–profile drug–safety problems, including the 2004 withdrawal of the painkiller Vioxx.

Also, lawmakers have a ready–made vehicle for the changes: legislation that must be approved this year to renew the deal under which the industry pays fees to fund much of the FDA's drug–review process. The current user–fee agreement expires later this year.

"It's pretty clear we have drug–safety problems, and it's clear we need to address those matters," says Rep. John Dingell (D., Mich.), chairman of the House Energy and Commerce Committee, which has jurisdiction over the FDA. Several lawmakers say the agency's latest drug–safety initiatives, announced Tuesday, need to be bolstered with new legislation.

While these bills are now stand-alone measures, many on Capitol Hill expect that whatever safety legislation moves forward will be combined with the user–fee bill. That legislation also might end up linked to proposals to create a pathway for FDA approval of generic versions of biotech drugs—which proponents argue would rein in the cost of such medicines—and allow imports of medication from overseas. Both provisions are opposed by the drug industry, which is pressing for a "clean" user–fee bill.

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How doctors battle to keep superbugs at bay
Financial Times, 2-2-07

Editor's Notes:

The Financial Times looks at how public health officials and pharmaceutical companies are responding to the growing death toll from antibiotic–resistant bacteria in hospital settings:

The number of deaths linked to superbugs has risen sharply over the past decade, resistance to existing drugs designed to treat them has been increasing and there are few new medicines in the pipeline.

While [methicillin resistant Staphylococcus aureus] has received most attention in the industrialised world, other bacteria such as Clostridium difficile pose related and important public health threats. In southern Africa and parts of eastern Europe, fresh concern has been sparked in recent months by extensive resistance to the already complicated and lengthy drug treatments available for tuberculosis...

Antibiotics transformed modern medicine but they did create a culture of greater complacency around infection. Doctors used them widely and in many countries they could be bought easily without prescription, while long–standing family advice on hand–washing faded...

The challenge in fighting bacteria with new drugs is that all the most promising avenues of development have been pursued, leaving today's researchers with a much harder task. Pharmaceutical analysts love to invoke the image of "plucking the low–hanging fruit" to explain why the industry is producing fewer and fewer new drugs as it spends more and more on research.

The image is particularly apposite in antibiotic development, partly because of the field's long history and partly because bacteria present fewer potential targets than the human biological pathways at which most other drug classes are aimed.

Further complicating antibiotics research is the tendency of doctors to use them sparingly, once they are on market, in order to slow the growth of antibiotic resistant bacteria. In short, the market for new antibiotics is self–limiting and much less lucrative than for other types of drugs.

To spur research into new antibiotics, policymakers should reward companies that engage in antibiotic research, perhaps with "wild–card" patent extensions in return for drugs aimed at the most dangerous pathogens. For more suggestions on how to spur new antibiotic research, see the report "Bad Bugs, No Drugs", from the Infectious Diseases Society of America.

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Perry orders cancer virus vaccine for young girls
Houston Chronicle, 2-3-07

Editor's Notes:

Earlier this week, Texas Governor Rick Perry signed an executive order requiring sixth–grade girls to receive Gardasil, a vaccine that protects against Human Papilloma Virus, a sexually transmitted disease that causes about 70% of all cervical cancers. Gov. Perry's decision, for all of its good intentions, is bound to be controversial:

By issuing an executive order, Perry apparently sidesteps opposition in the Legislature from conservatives and parents' rights groups who fear such a requirement would condone premarital sex and interfere with the way parents raise their children.

...

Perry, a conservative Christian who opposes abortion and stem-cell research using embryonic cells, counts on the religious right for his political base. But he has said the cervical cancer vaccine is no different from the one that protects children against polio.

"The HPV vaccine provides an incredible opportunity to effectively target and prevent cervical cancer," Perry said in announcing the order.

Merck is bankrolling efforts to pass state laws across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country

...

Parents can have their daughters opt out of the inoculations by filing an objection on religious or other philosophical grounds. Even with such provisions, however, conservative groups say such requirements interfere with parents' rights to make medical decisions for their children.

The federal government approved Gardasil in June, and a government advisory panel has recommended that all girls get the shots at 11 and 12, before they are likely to be sexually active.

The vaccine is too new to know how long protection will last, according to the federal Centers for Disease Control and Prevention. Studies have followed women for five years and found that they are still protected. More research is being done to find out how long protection will last, and if a booster vaccine is needed years later.

Governor Perry’s order, it should be noted, also comes with a fairly broad opt–out provision for parents who do not wish to have their daughters vaccinated.

The Houston Chronicle implies that conservative Christians are spearheading resistance to mandatory HPV vaccinations, but public unease spans the political spectrum. Many parents remain suspicious of mandatory vaccinations, and there is a legitimate question about the long term efficacy of the vaccine.

Undoubtedly, Merck's vaccine is a life–saving innovation. But it may be shortsighted to mandate Gardasil vaccinations before the public has been fully educated on the usefulness and need for the vaccine.

As a result, Merck and well–intentioned policymakers are risking a political backlash from a public that is already leery of vaccines and pharmaceutical companies in general. Rather than moving to short–circuit debate with mandatory vaccinations, the better course would be a more prolonged period of public education and discussion.

For a different perspective on HPV vaccinations, see this article from the University of Pennsylvania's Center for Bioethics.

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As oral cancer drugs gain, dosage problems grow
The Boston Globe, 2-4-07

Editor's Notes:

The Boston Globe reminds us that medicine would be a lot simpler if doctors didn't have to deal with people.

Researchers have been aware for some time that compliance rates (patients taking their meds as the doctor ordered) for diseases like heart disease and diabetes can vary widely and have an enormous impact on the long-term health and safety of patients.

What they did not anticipate, the Globe reports, was that as more cancer treatments became available in pill form, cancer patients would experience similar problems with "underdoses, overdoses, and just plain mistakes."

Cancer–fighting medicines are increasingly available in pill form, giving patients far more control over their care in a field long dominated by drugs delivered through intravenous tubes at clinics or hospitals. Last year alone, the US Food and Drug Administration approved five new oral cancer treatments, and a quarter of the cancer drugs under development are capsules or tablets. Intravenous treatments are still the norm, but oncologists are rapidly increasing the number of oral treatments they prescribe, especially for certain cancers such as breast tumors, for which most survivors receive pills for up to five years after initial chemotherapy.

As a result, cancer patients increasingly receive at least some of their medications at home, and can sometimes go weeks or months without checking in at the cancer clinic. In addition to the convenience, oral treatments tend to cost less and some newer medicines have fewer side effects than conventional chemotherapy.

But the take–at–home arsenal greatly increases the risk of underdoses, overdoses, and just plain mistakes as patients wrestle on their own with unpleasant side effects, complex treatment plans, and simple cancer fatigue. More than half of patients taking one widely used oral chemotherapy, Xeloda, occasionally cut back their dose or take a medication "break" to reduce side effects such as nausea and skin irritation, according to a survey of oncologists. A pancreatic cancer patient taking Xeloda explained how he managed his medication : "I take the pills until I develop a funny rash on my hands and then I back off a little bit."

Cancer specialists are only now waking up to the scope of the "non adherence" problem, and one–quarter of cancer centers don't have a formal system to track patient compliance with their oral treatment plans, according to a survey by Dana-Farber Cancer Institute researchers published in the British Medical Journal last month. In addition, many centers don't take as many safety precautions for oral treatments as they do for the intravenous infusions given under the watchful eye of staff members.

In broader terms, the Globe reminds us that our fee–for–service health care system reimburses physicians largely for output: pills handed out, MRI scans, arteries unclogged. It does not reward providers for going above and beyond the call of duty, i.e., following up with patients to make sure that they take their medicines as ordered. We need a health care system that reverses this equation, and focuses on providing the best value to the patient.

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