Latest Drugwonks' Blog
“Based on what you know or have heard …”
58% of people in a new Wall Street Journal Online/Harris Interactive health-care poll (conducted online May 12-16) said that, “based on what you know or have heard,” the FDA does a fair or poor job ensuring the safety and efficacy of new prescription drugs, while 36% said the agency does a good or excellent job.
Based on what you know or have heard.
Two years ago, the numbers were reversed: then, 56% felt the FDA did a good or excellent job in the ensuring safety and efficacy of new prescription drugs, while 37% felt the agency did a fair or poor job in this regard.
Based on what you know or have heard.
Of 2,371 adults surveyed in the latest poll, 80% said they are somewhat or very concerned about the agency’s ability to make independent decisions that will ensure patients have access to safe and effective medicines.
Based on what you know or have heard.
The poll found that 82% feel the FDA’s decisions are influenced to some extent or a great extent by politics rather than medical science.
Based on what you know …
Most Americans don’t know the most basic things about what FDA is and what it does. And ignorance rarely evokes bliss. Most Americans think the FDA invents as well as regulates pharmaceuticals.
Or have heard …
What most Americans have heard over the past two years are false accusations, slanted half-truths, self-serving pronouncements, ad hominem attacks, vicious slander, and destructive score settling.
This is what some of our elected public officials hath wrought. And what have these same individuals done to improve matters?
(Pause for reflection)
I can’t think of anything either.
As George Bernard Shaw wrote,
“When a stupid man is doing something he is ashamed of, he always declares that it is his duty.”
For shame. And you know who you are.
According to Robert Pear “Democrats said they were counting on the doughnut hole to revive public criticism of the Medicare drug benefit, which has died down since March, when many of the initial problems were straightened out.”
“… Nancy Pelosi of California, has urged Democrats to hold town meetings and other events to keep up the drumbeat against the program, which she has decried as this disastrous Republican Medicare drug plan.”
The truth? Can Nancy Pelosi handle the truth?
FDA Releases Medical Device Innovation Initiative
It’s about time.
According to the FDA website, “… The Center for Devices and Radiological Health (CDRH) is taking new steps to expand its current efforts to foster the development of safe and effective medical devices through a variety of initiatives and regulatory process improvements … This initiative includes the following efforts:
* Promoting scientific innovation in product development (Provide Regulatory Clarity Through Guidance Development, Invest in the Critical Path, Conduct Stakeholder Outreach and Improving Communications);
* Focusing device research on cutting edge science (Laboratory Research to Support Efforts to Improve the Device Development Process);
* Modernizing review of innovative devices (Implement a Quality Review Program, Provide Clarity Through Guidance Development, Leverage Information Technology Solutions, Expand Clinical and Scientific Expertise at FDA)”
A link to the full statement can be found at www.fda.gov.
Stephanie Saul has found the formula to make the front page of the NY Times: write article about the Rx industry that depict their products as unsafe or demonstrate an unholy link between clinical guidelines and industry support. Oh, and ignore the facts when you have to in order to keep the story line in shape. The most recent example of Stephanie’s shameless stylistics is today’s article entitled, “Unease on Industry’s Role in Hypertension Debate ” which starts out by noting that drug companies paid $700k ” to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure…. The same three companies â Merck, Novartis and Sankyo â also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs. …”
Let’s get one thing straight first. Most people with hypertension don’t take drugs and those that do fail to take them regularly or appropriately. So is it a bad thing to increase the numbe rof people taking drugs given the fact that high blood pressure is the leading cause of strokes and heart attack in the world and taking such drugs will cut strokes 35 to 40 percent and heart attacks 20 to 25 percent?
Now what Stephanie is talking about is something call pre-hypertension. No one seems to quibble about treating pre-cancer though fewer people die from cancer than heart disease but no matter. Or that from both a mechanistic and epidemiological level is pretty flat out certain that both elevation of blood pressure and lipid levels begin early in life, even in childhood in some people. Didn’t read that in Stephanie’s screed? What a suprise. High blood pressure was listed as a primary or contributing cause of death in about 277,000 American deaths in the year 2003. About 69 percent of people who have a first heart attack, 77 percent of those who have a first stroke, and 74 percent of patients with heart failure have blood pressure higher than 140/90 mmHg. Since blood pressure rises rapdily the idea is to prevent the exponential rise by getting to people who are on the cusp before it does as a way to stop hypertension before it starts. On the number of people on the cusp — prehypertenion — have been rising rapidly as well. So researchers wanted to see if you could slow the progression to hypertension by giving folks on the cusp blood pressure drugs. It did.
But all Stephanie could see was that Astra Zeneca paid for the study, not the potential public health beneifits of lowering blood pressure earlier than ever or the the fact that efforts to do so through diet and exercise alone have been a miserable failure. Obesity epidemic anyone?
Also, she left out some interesting facts. That the two “heroes” of her piece, Steve Nissen and Jean Sealey, have problems of their own. Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, as followers of this blog know, abused his position as a FDA media talking head and FDA advisory committee member along with another malcontent on Stephanie’s speed dial, Curt Furberg, MD to recommend a black box warning on drugs for ADHD in order to slow what he characterized as the âout of control growthâ use of the drugs.
Meanwhile Stephanie depicts Sealey leaving the professional association of hypertension specialists as a principled decision and a outgrowth over a battle about Rx influence. In fact, Sealey was on the verge of being forced to resign for reasons that are being investigated by the New York State Attorney General. Amazing how that never made it into the New York Times. It’s enough to give you pre-high blood pressure.
Does Pharma suffer from Fear of Blogging? Of course. And with good reason. If you would like more information on this topic, may I recommend a new report by HCPro. It’s not out until June … but that’s, well, next week. It features interviews with various experts including the wonderfully bright Coleen Klasmeier and me.
The HCPro web address is www.hcpro.com
Friday’s Wall Street Journal editorial, “Medicare Bidding War,” left many people confused — me among them — as to how the Journal could be so wrong about something so important — the Part D benefit.
Not surprisingly, the man with the best answer is Mark McClellan. And, as per usual, he addressed the very questions posed by the Wall Streeet Journal even before they were asked. In this case at a May 2nd speech at the American Enterprise Institute.
Here’s a link to his prescient remarks:
http://www.aei.org/events/eventID.1322,filter.all/event-detail.asp
Two years ago CMS stood for “Can McClellan Succeed?”
One year ago it meant “Can McClellan Survive?”
Today it means the future of American health care.
I attended a small lunch yesterday with Dr. McClellan and he made it very clear that now is not the time to take a victory lap. There’s much more yet to be done.
Typical McClellan. That’s why he is the Hardest Working Man in Health Care.
But he did share a few key facts and memorable anecdotes.
Key Fact #1:
The average premium cost is lower than the initial Federal estimate by 30%.
Can you say ” C - O - M - P - E - T - I - T - I - O - N “ ?
Mark also told of the time and shoe leather he and other members of the CMS team spent on the health care hustings. Two stories bear repeating.
The first, according to Dr. McC, happened on a number of occasions. He tells of seniors coming up to him in tears —because they can finally afford the medicines they need.
And Mark, as those of you who know him will attest, is not prone to hyperbole.
The second tells of a woman at a senior center who, after hearing him speak, said that even though she wasn’t currently taking any prescription drugs she was going to sign up because …
“You never know what’s going to happen when you get older.”
To which Mark asked, “How old are you now?”
Her reply, “102.”
With age comes wisdom.
When it comes to New Hampshire, “Live free or die” is a great state motto — but it’s terrible health care policy.
Latest case-in-point, HB 1346, a bill just passed by the New Hampshire legislature, that would make it illegal for pharmaceutical companies to have any access at all to physician prescribing data. This is a simplistic solution to a complex problem.
While I agree that physician-prescribing data shouldn’t be available for marketing purposes minus individual physician consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.
According to a spokeswoman, Governor Lynch will be looking at HB 1346’s “impact on health care costs and personal privacy.” That’s fine. But the Governor should also consider its implications on public safety.
Tomorrow WHO will call for a new policy in clinical trial transparency that is transparently absurd, absurdly transparent, and deleterious to the public health.
In its effort to develop worldwide standards of trial registration, WHO formally launched its International Clinical Trials Registry Platform (ICTRP) in April 2005. Tomorrow WHO plans to go public with its proposed final policy on which trials should be registered, and when. The policy will recommend registration of every “interventional study” (i.e. every trial for every intervention, whether marketed or not; whether randomized or not; and whether early phase or late phase).
Give me a break.
WHO wrongly claims that its policy is justified by the need to meet “ethical obligations to study participants.” Those obligations are already met in full, by disclosures to regulators, to independent review boards and ethics committees overseeing each trial, to every clinical investigator participating in each trial, and most importantly to every patient.
Ironically, while not remedying an ethical issue, WHO’s proposal may create one. In its call for registration of exploratory studies, particularly Phase I studies, WHO would fill the registry with vast amounts of data of no medical value. Every user would be compelled to sift this mountain of chaff to find the kernels of useful information; and might mistake the chaff for wheat. Phase I and other exploratory studies serve a narrow purpose and outside that context their results are inherently unreliable. Registering these trials or disclosing their results would at best confuse patients and encourage false hopes. At worst, where non-experimental drugs are being tested for new indications, physicians might inappropriately rely on disclosed trial information to make prescription decisions before confirmatory safety or efficacy trials have even been started.
From an ethical standpoint it is not at all clear what public health purpose is being served by this disclosure, nor which individuals it will benefit.
And then there are the myriad questions surrounding IP issues.
WHO’s policy of registering all interventional studies will make it harder or impossible for research based companies to secure important IP around selection inventions, manufacturing and formulation claims, and important new uses. Without this protection, sponsors may either abandon such research or else increase their precautionary patent filings at a time of high project attrition. This will drive up the cost of development, reduce the number of projects, and delay the progress of products to the marketplace.
The IOM has a better idea. In a recent workshop report they endorsed a more practical and beneficial guiding principle “Avoid reducing the incentive to do clinical research, whether public or privately funded.”
The net effect of the proposed WHO policy is that patients will wait longer for fewer and more expensive medicines, in exchange for a trial registry policy that benefits nobody.
That’s a Geneva Convention we can do without.
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.
