Latest Drugwonks' Blog
When I was at the FDA and we announced a new draft guidance on DTC print advertising, Dr. McClellan commented that when it came to the brief summary “less may indeed be more.”
Today the agency is calling for more research into this issue — but solid metrics already exist. Right now, as we speak, the FDA possesses a broad body of high quality research that has been conducted on the brief summary — with protocols reviewed and commented on by the folks at DDMAC.
The news item below is all well and good — but calling for more research is a poor excuse for lack of action on this important public health issue.
(FYI — Inside the agency the brief summary is often derided as being like the Holy Roman Empire — it is neither brief nor a summary).
FDA Will Survey Consumers on Brief Summary
The FDA plans to survey consumers on the content and format of the brief summary in direct-to-consumer ads, according to an advance Federal Register notice released April 24. “In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements” because the detailed, technical prescription drug information geared toward physicians increasingly was used in ads for the public as a way for advertisers to fulfill the vague brief summary requirements, the notice states.
The FDA plans to investigate the role of context in providing useful information to consumers, such as comparing consumer perceptions after viewing mock ads with risk information in chart or paragraph form. The agency also will study whether listing side effects and placebo rates of occurrence influences perception. Additionally, the FDA will survey the effectiveness of brief summary information provided in question-and-answer, highlights and drug facts formats. The agency will accept comments for 60 days after publication in the Federal Register under docket number 2006N-0133.
An unpublished letter by drugwonks commentator Ben Zycher. A loss to Washington Post readers — but a drugwonks.com bonus!
To the Editor of the Washington Post,
Shankar Vedantum’s article (“Comparison of Schizophrenia Drugs Often Favors Firm Funding Study,” April 12) misses the central reason that comparative drug tests funded by a given pharmaceutical producer usually report superiority for that producer’s drugs. The research and development process for new drugs aims to improve upon the clinical experience of existing treatments, which always are weak for some patients and for some of the many dimensions of such disorders as schizophrenia. To the extent that the research and development process is successful, studies conducted to determine whether or not the new treatments offer improvement for some patients in terms of some symptoms will find, quite honestly, that they do indeed.
Moreover, no advertising or promotion of such new drugs may proceed until the data are reviewed and approved by the FDA. And the argument of some that studies funded by government systematically will yield unbiased comparisons is incorrect: The government has powerful incentives to promote certain (older) drugs, the use of which will reduce budget pressures. Pharmaceutical producers have profit incentives not to mislead themselves, and doctors and patients have strong reasons to find the most effective treatments.
Here’s a link to a new paper (by me) discussing how Europe can learn from America’s DTC experiences (both positive and otherwise) to create a more robust 21st century environment for patient empowerment. My premise is that health care communication is the consumer’s Rosetta Stone.
Your thoughts and comments are much appreciated.
Such a revelation! GAO reports that the FDA can do better on post-market surveillance! The headlines and statements from Senator Grassley shout “OMG!” But those in the know remark, “Duh.” The issue, dear Senator must not begin and end with a press conference. (The headlines taste good, but 45 minutes later you’re hungry again.) The debate and road to amelioration must begin with more dollars and authority for the FDA. Senator, for the umteenth time — SHOW FDA THE MONEY!
As for Dr. Goldberg’s comments below, ditto.
Genetic tests that will screen people to see if they are high responders will be used in combo with proteomic or metabolomic tests to develop optimal doses and imaging markers to determine best response. Such work is already going on in cancer and with such drugs as Avastin. More on that later.
Yesterday David Brailer, who leads the nation’s health IT efforts, announced he is stepping down from that post to spend more time with his family. Brailer has spent the last two years herding cats but also championing the need to get serious about investing in all forms of health IT. He helped created a vision and a critical mass as well as — dare I use the term — a tipping point towards the development of a framework in which health information becomes an important tool for improving health and preventing disease. We should thank him for a great job and for devoting his time and energy to public service.
From the Financial Times
http://news.ft.com/cms/s/8bd2bdb6-d094-11da-b160-0000779e2340,s01=1.html
According to the MIT Technology Review an international group of scientists has demonstrated a new tool for personalized medicine that makes it possible to predict nearly any adverse reaction an individual might have to drugs. Rather than being based on genetic screening, which up to now has been the dominant approach to personalized medicine, the new test relies on profiling an individual’s metabolic products.
Called pharmaco-metabonomics, the technique involves screening urine for metabolite: small molecules that are involved in or produced by the metabolic processes that sustain an organism.
Besides predicting adverse drug reactions, pharmaco-metabonomics also has the potential to determine more effective dose levels for each individual. “There is no genetic technique that can do that,” says Jeremy Nicholson of Imperial College London, the researcher who led the investigation.
Here’s a link to the complete article:
On Thursday, Medicare officials released new statistics showing that 8.1 million people are now enrolled in stand-alone Medicare prescription drug plans, an increase of 1.7 million in the past four weeks. More than 30 million of the nation’s nearly 43 million Medicare recipients now receive some assistance in paying for their medications.
“Strike up the Klezmer and start acting like a man. You’re about to have a Truth Mitzvah.” — Steven Colbert
According to a widely reported new paper, every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses.
Here we go again. God forbid we should have schizophrenics treated with medication.
The American Psychiatric Association, which publishes the Diagnostic and Statistical Manual (DSM), said it is planning to require disclosure of the financial ties of experts who write the next edition of the manual — due around 2011. The manual carries vast influence over the practice of psychiatry in the United States and around the world.
And that’s as it should be. Disclosure and transparency are, as Martha would say, “good things.”
John Kane, an expert on schizophrenia who worked on the last edition, commented that, “It shouldn’t be assumed there is a true conflict of interest.” Kane said the report’s conclusions were driven only by science. “To me, a conflict of interest implies that someone’s judgment is going to be influenced by this relationship, and that is not necessarily the case.”
Indeed. I guess Citizen Kane didn’t get the memo that explains why, if you are in any way associated with the pharmaceutical industry, you are guilty of crimes against humanity even if you’re innocent. And if you’re innocent you’re naive and are being used by the industry for its nefarious purposes. Witness the headline in the Washington Post, “Experts Defining Mental Disorders Are Linked to Drug Firms.” Can you say “leading the witness?”
Steven Sharfstein, president of the American Psychiatric Association, said, “I am not surprised that the key people who participate have these kinds of relationships. They are the major researchers in the field, and are very much on the cutting edge, and will have some kind of relationship — but there should be full disclosure.”
You bet. Disclosure. Disclosure. Disclosure. But here’s the question phrased differently — Why does the pharmaceutical industry only do business with the smartest minds in medicine? Answer: Because they are the smartest minds in medicine.
The analysis could not determine the extent or timing of the financial ties because it relied on disclosures in journal publications and other venues that do not mention many details, said Sheldon Krimsky, a science policy specialist at Tufts University who also was an author of the new study. Whether the researchers received money before, during or after their service on the panel did not remove the ethical concern, he said.
And, in the interest of transparency and disclosure, Mr. Krimsky is the author of the book “Science in the Private Interest,” so we certainly can guess at his general perspectives on the issue.
Should professional relationships be disclosed? Most certainly. Should the best minds in medicine be recused from sharing their wisdom? Certainly not.
Drugwonks.com is pleased to be part of a blogposium on Clinical Informatics, a neighborhood of folks with a passion to advance understanding on how bioinformatics and electronic patients records can improve health care. Jack Mason is the blogposium’s chair. He can be contacted at healthnex@gmail.com.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
