Biomarkers Improving Regulatory Reviews and Drug Development

June 13, 2008 / Michael D. Miller MD / FDA, Innovation / No Comments

The FDA announced yesterday that both the FDA and the European Medicines Association (EMEA) will accept seven biomarker tests for early kidney damage. These animal based tests were developed by a public-private collaborative and will be a voluntary part of the regulatory applications for new drugs. However, it is believed that companies will benefit by doing these test because they will both be able to detect toxicity problems earlier in a drugs development, and enable the approval of more powerful drugs, “because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.”

“The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs,” said Janet Woodcock, M.D.,

…

People in Clinical Trials: Patients or Subjects?

May 8, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, FDA, Innovation / 1 Comment

Are people who participate in clinical trials patients or subjects? This may seem like a minor rhetorical difference, but I believe it has tremendous implications for health and biomedical research policy. Let me explain why –

Clinical trials are experiments to discover new knowledge. Their intent is to see if a new way of treating a specific disease or condition is better than, the same as, or worse than, another option – either a placebo or an established treatment. Therefore, when people agree to participate in a clinical trial they are participating in this experiment, and their fundamental goal for participating should be to help future patients by expanding biomedical and/or clinical knowledge.…

FDA’s Resources for Evaluating and Monitoring Medicines and New Science

April 24, 2008 / Michael D. Miller MD / FDA, Politics, Quality of Care & Safety / No Comments

For several years it has been clear that funding limitations are impairing the FDA’s ability to attract and retain qualified clinicians and scientists to review applications for new drugs and biologics, and to support their internal research and analysis concerning new drug development, manufacturing and monitoring technologies – particularly for biologic medicines. In addition, the FDA hasn’t been able to update its information technology systems to maximize staff productivity. (I suspect some people will be tempted to comment on the “productivity” of government employees, but I have found the FDA’s professional staff generally very qualified and hard working.)

On Tuesday, the Energy and Commerce Committee in the US House of Representatives held a hearing about the FDA’s ability to adequately oversee foreign production of medicines being sold in the US.…

1 of 100 Adults Gets Free Government Health Care

April 21, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicaid, Politics, Private-Employer Based Health Insurance / No Comments

A recent report from the Pew Foundation indicated that 1 out of 100 adults in the US get free government health care with no premiums, deductibles or co-payments. The reason this report didn’t get more media attention was because the 1% of Americans getting free government health care are behind bars – as in prison or jail.

The Pew report indicates that for the first time, more than 1 in 100 adults in America are in prison or jail. That’s over 2.3 million in state or federal prisons or local jails, and the numbers and percentages have been growing. (See the Department of Justice chart below)

This data is an interesting launching point into other aspects of our current health care system’s problems:

First, health care costs for people behind bars represent about 10% of the costs of incarceration.…

A Perfect Stormy Mess for Health Reform

April 15, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Federal Healthcare Reform, Health System Reform, Medicaid, Politics, State-Level Healthcare Reform / 4 Comments

A year ago the hype in healthcare was about state-based reform initiatives. Massachusetts was implementing its law, and several other states – including California – were considering their own proposals for increasing insurance coverage as a first step towards universal coverage and cost containment.

How things have changed in a year. Not only has California’s initiative crumbled under the expected costs to employers, but the economic downturn has undercut states’ healthcare expansion ideas, and may force them to cut back Medicaid enrollment and/or services. This week’s National Journal has an article titled “State’s Rapidly Shifting Gears,” that discusses these and other issues, including how a few years ago states cut their Medicaid payments to providers, so that on average Medicaid pays physicians 69% of Medicare levels, and how pending Federal Medicaid rules and proposals would reduce funding for State Medicaid programs making it difficult for states to reverse these payment reductions.…

The Stressed and Strained Health Care Workforce

April 15, 2008 / Michael D. Miller MD / Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Medicaid, Medicare, Public Health / 2 Comments

The Institute of Medicine put out a report yesterday titled “Retooling for an Aging America: Building the Health Care Workforce.” The report discusses how the aging of the baby-boom generation will create greater needs for health care providers (of all types) who are trained in caring for the elderly with chronic conditions. The report’s recommendations fall into three categories: training, system transformation and financing. Like many reports about health system improvement, their recommendations all make sense – particularly within the context of the three categories. However, like many IOM reports, the writing by Committee process is a bit evident in that, (at least from the Executive Summary), it doesn’t seem to describe a complete plan, nor does it prioritize any of its recommendations – either in terms of funding or which actions should be done first.…

Information Can Change Medical Practice, Patient Behaviors, and Kill Kids

April 10, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Public Health, Quality of Care & Safety / 1 Comment

Medical information can change how clinicians treat patients, how patients care for themselves, and how healthcare payers promote or prevent the use of treatments and diagnostic tests. However, this information can act as either a broad sword or a scalpel, and produce good or bad outcomes.

A recent report from a Canadian new service about an article from the Canadian Medical Association Journal describing the outcomes from warning about the use of anti-depressants in children brings this issue down from a general concept to being very specific. This news report stated:

Two years after Health Canada warned about prescribing anti-depressants to children, the number of children and teens who died by suicide increased 25 per cent after years of steady decline, major new Canadian research shows.

…

Toxic Dietary Supplements

April 10, 2008 / Michael D. Miller MD / FDA, Nutrition, Public Health, Quality of Care & Safety / No Comments

I’m usually either supportive or neutral about alternative therapies because they generally aren’t harmful, and can be beneficial. However, there seem to be more and more recalls of these products by the Food and Drug Administration (FDA) for mislabelings that are significant, although seemingly not extremely dangerous.

On the other hand, I was struck by a press release I got yesterday from the FDA about a recall for the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The recall was because these products had more than 200 times the amount of selenium than was printed on the products’ label – and the press release noted that, “Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.”…

More on the Supply of Primary Care Clinicians

April 9, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicare, Politics / No Comments

Yesterday, when I wrote about “Ensuring Enough Primary Care Clinicians,” I didn’t realize that public radio station WBUR would be doing a story this week on the same topic. (The WBUR story can be heard/read on their web-site.)

Nor did I know that this was an agenda item for today’s Medicare Payment Advisory Commission (MedPAC) meeting. While the one-page MedPAC briefing summary doesn’t include their draft recommendations, Modern Healthcare reports that they are recommending budget-neutral adjustments to Medicare’s fee schedule to increase payments to physicians who provide primary-care services – including office and home visits, and visits to patients in non-acute facilities.…

Ensuring Enough Primary Care Clinicians

April 8, 2008 / Michael D. Miller MD / Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Economics & Financing, Health System Reform, Politics / 3 Comments

Like many complicated problems in the US healthcare system, setting a goal can be easy, but achieving it can be hard. In recent years there has been a number of proposals for increasing the use of primary care clinicians to help patients with chronic diseases (like diabetes) manage their care and avoid long-term complications – and to presumably lower long-term healthcare spending. For example, the “Patient Centered Medical Home” proposal supported by a dozen organizations, (including companies and family practice and pediatrics associations), doesn’t specifically use the term “primary care,” but it gets to the same result – heightened relationships and communications between patients and a particular clinician or clinic.…

Canada’s Proposal for Subsequent Entry Biologics

April 1, 2008 / Michael D. Miller MD / Economics & Financing, FDA, Patents & IP, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange / No Comments

After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

“SEBs are not ‘generic biologics'”
Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act.…

More on Counterfeit Medicines & Safety

March 27, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, FDA, Information & Communications, Public Health, Quality of Care & Safety / No Comments

My last post contained some perspectives about fake medicines. That same day, the LA times ran an article about California’s long-delayed pedigree requirements for tracking prescription medicines. This law was prompted by the discovery of fake medicines for HIV/AIDS in 2000, and was intended to achieve what the FDA has been trying to implement for many years.

The LA Times article blames the delays in the state’s drug tracking system on the industry – from the manufacturer to the retail pharmacy. I suspect that the real challenge is not in the technical or cost aspects from the manufacturers – who certainly have lots to gain by stopping counterfeits of their products from being sold instead of the real thing, but from the wholesalers and to a lesser extent the pharmacies.…

«‹3 4 5 6 ›