Off-Label Communications: Is More Less?

October 4, 2009 / Michael D. Miller MD / Delivery of Healthcare, FDA, Information & Communications, Quality of Care & Safety / No Comments

Allergan corporation has filed a law suit against the Federal government challenging the FDA’s limits for companies discussing or promoting off-label uses of approved medicines. This is not a new issue, but the news reports indicate that Allergan is going very old school and basing their legal challenge on Constitutional freedom of speech rights.

The issue is not can doctors and patients use approved medicines for conditions, (or in ways), which are not specifically approved by the FDA, but can companies discuss these off-label uses with physicians or provide them with published information about these off-label uses?

Competing Risk-Benefit Perspectives
The competing risk-benefit perspectives that surround this issue are nearly identical to the trade-offs that all stakeholders in biomedical research and development face – including the FDA, companies, patients, clinicians, and legislators:

Creating a landscape that protects individuals and public safety
Being flexible enough to provide clinicians and patients access to the best available treatment possibilities
Providing companies a reasonable market environment that creates incentives for developing new treatments and investigating new uses for already approved medicines, which also has marketing rules that are as clear as possible so companies can conduct business without being excessively concerned about straying into regulatory gray zones

Off-label use is common in clinical practice – particularly for disease areas like cancer – because it often represents the standard of care. …

Groups Seeking Funds in Health Reform

January 12, 2009 / Michael D. Miller MD / Economics & Financing, FDA, Medicaid, Medicare, Politics / No Comments

With all the anticipation about health reform happening soon, many groups are expecting increased Federal funding for different things, e.g. electronic medical records, expansion of SCHIP and Medicaid (or at least great funding assistance to States), more emphasis on personalized medicine, more resources for FDA to help them with their expanding domestic and international responsibilities, closing the donut hole in the Medicare outpatient prescription drug benefit, fixing Medicare’s physician payment formula, etc.

Another area looking for increased emphasis and funding – both as part of health reform and economic/jobs stimulus – are biomedical researchers. The Boston Globe and Mass High Tech had articles last week describing how the Massachusetts Life Sciences Collaborative is lobbying for more NIH grant money. …

Personalized Medicine – Fulfilling the Promise of Genetic Research

November 17, 2008 / Michael D. Miller MD / Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Innovation, Quality of Care & Safety / No Comments

It has been 55 years since the discovery of the structure of DNA, and 40 years since James Watson published his account of that discovery in his book, “The Double Helix.” (A picture of my autographed copy is below.)

Ever since DNA was discovered to code for the structure of most living things, there has been the hope that understanding abnormal genetics would lead to the ability to treat or cure a vast array of illnesses. Unfortunately, that progress hasn’t been as rapid as originally hoped. But medical science is now beginning to put genomic research discoveries into actual medical practice, and start customizing medical treatments based upon each individual patient’s genetic makeup – the fundamental concept of “Personalized Medicine.”…

Communicating Health Information and this Blog’s Goals

October 30, 2008 / Michael D. Miller MD / FDA, Health Policy and Communications Blog, Information & Communications, Quality of Care & Safety / No Comments

Noting that I’ve written about a wide variety of health and biomedical research issues, someone recently asked me about the focus of this blog. My response was that my goals are two-fold: First, to present synthesized information – created by combining different sources and analyses – in ways that provide new perspectives on important issues so that people have both broader and deeper understanding of these issue. And second, to reach multiple audiences with this information and perspectives so that the spectrum of healthcare stakeholders can better communicate and understand each other. Which is just stating in a different way what I wrote in my first posting, that the reason I started this blog was “to provide stakeholders of all types, (such as patients, clinicians, administrators, payers, researchers, regulators, legislators, etc.)…

Direct to Consumer Advertising: Drugs, Hospitals, Research….

October 23, 2008 / Michael D. Miller MD / Access to Healthcare, FDA, Information & Communications, Politics / 4 Comments

A very contentious health policy issue is that of advertising. Usually the specific topic is the advertising of medicines directly to patients – known as “Direct to Consumer Advertising.” There have been proposals to limit or ban this activity, and some states have, (or have proposed), limiting or requiring disclosure of other marketing activities by pharmaceutical companies – such as marketing directly to doctors and hospitals.

However, I’ve found it intriguing that many other components of the healthcare industry advertise directly to patients. For example, the Boston area free daily paper, Metro, contains lots of ads recruiting people to participate in medical research trials. …

Stem Cells, Cancer, and Politics

September 15, 2008 / Michael D. Miller MD / Access to Healthcare, FDA, Information & Communications, Innovation, Politics / No Comments

The cover of this week’s Economist magazine caught my eye because this weekend I was talking with people about stem cell issues in the context of the Presidential election.

Part of our discussion was how the selection of Sarah Palin as John McCain’s Vice Presidential nominee will effect the Republican ticket’s position on stem cell research.

Doing a quick search on the internet, it appears that John McCain is refining in his position to support research on adult stem cells, while maintaining a foundation that doesn’t alienate the conservative base of his party. Specifically, the only reference to stem cell research that I could find on the campaign’s web-site is:

Addressing the Moral Concerns of Advanced Technology

Stem cell research offers tremendous hope for those suffering from a variety of deadly diseases – hope for both cures and life-extending treatments.

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E-Prescribing – Good? E-Dispensing Bad!!

July 10, 2008 / Michael D. Miller MD / Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, FDA, Information & Communications, Miscellaneous, Public Health, Quality of Care & Safety / 1 Comment

With two notable government actions in the last couple of weeks there has been significant movement towards increasing the use of e-prescribing.

DEA Proposed Rule
The Drug Enforcement Agency (DEA), proposed regulations on June 27th that would make it possible for controlled substances to be prescribed electronically. Interestingly, this was released right after a National Journal article on this topic.

The DEA’s proposed rule is very important, because while it is appropriate to place stronger safeguards on medicines that are likely to be abused (which is the criteria for being a DEA scheduled medicine), having controlled medicines prescribed by pen and paper while all other medicines are e-prescribed would be a logistical problem and obviate many of the potential benefits of e-prescribing. …

Cracking Down on Fake Cancer Cures

June 17, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, FDA, Public Health, Quality of Care & Safety / No Comments

The FDA announced today that they have sent letters to 25 companies to stop selling fake cancer cures. That is, things that the companies claim cure cancer, but have never been tested, or approved by the FDA. The FDA has a web-site with more information about this, and a sub-page that lists 125 Fake Cancer Cures.

I know the FDA gets lots of flack for not doing enough – and not doing it fast enough – I applaud the FDA for taking this action, and encourage them to do more because I have found the advertisement and selling of these non-medicines troubling for a long time.…

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.,

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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.…

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.

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