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A presidential executive order will establish a Department of Health and Human Services Office of Health Reform that will coordinate "closely" with the White House health reform office led by Nancy-Ann DeParle,
The executive order doesn’t not name the head of the new office, but cognoscenti point to Jeanne Lambrew who was originally recruited to serve as Daschle's deputy in the White House. Since Tom’s tax troubles, she has been parked at HHS in an undefined role.
It is likely that Ms. Lambrew will act coordinator between the White House and HHS on healthcare reform-related issues.
The order also officially establishes the White House reform office. According to the executive order, the principle functions of the White House Office of Health Reform are to lead and coordinate development of the administration's policy development across executive departments and agencies, including the Domestic Policy Council, National Economic Council, Council of Economic Advisors, Office of Management and Budget, HHS and Office of Personnel Management.
The office will integrate the White House policy agenda across the federal government and coordinate public outreach to gather input from the public, from demonstration and pilot projects, and from public-private partnerships on priorities for policy measures.
We anxiously await the manner and methods this office will use to “gather input from the public” and how they chose who those publics are.
Who’d a thunk it – the pharmaceutical industry recognizing that a well-funded, robust FDA is actually in their best interest? Well, credit AstraZeneca chief executive David Brennan, who also happens to be the new chairman of PhRMA.
According to Brennan, a “strong, well-functioning” Food and Drug Administration is needed “but an understaffed and under-funded FDA is an agency in crisis.” And, further, “we’re working hard for increased appropriations to the FDA so that it is recognized as a watchdog with a full set of teeth.”
Speaking directly to President Obama’s call to “cure cancer,” Brennan said that “contrary to the Hollywood-like scenarios, our battle with cancer isn’t so much about spectacular breakthroughs as it is about steady, incremental progress.” However for that to continue “requires policies that are more conducive to the medical innovation that is the genesis and cornerstone of our industry…we need an environment that includes strong, well-defined intellectual property rights.”
The next target on IMAP's radar screen: patient advocacy groups, many of which receive all or nearly all of their funding from the drug, biotechnology or medical device companies. "We're going to address these patient advocacy groups, some of which are grass roots and some of which are astroturf," Rothman said.
Patient Advocacy groups need to be alerted that this very effective strategy as seen with Academic Medical Centers (Brennan paper 2006, followed by AAMC Taskforce 2008, followed by major reforms 2009), and now Medical Specialty Societies is a model that is working for IMAP. This will be used against them.
They want to cause shame for doing the right thing (working with industry to develop new products that saves lives) even if it costs more in the short run.
This Strategy should be exposed for what it really is, short sighted contempt. Medical Societies, Academic Medical Centers and Patient Groups need to stand up against this bullying tactic; otherwise as a society we will all suffer the consequences of a lost medical research and education base.
Tom Sullivan is too kind. This is intellectual fascist. Rothman represents a point of view that is toxic to the public health, that all "science" must be cleansed of the biases and viewpoints he and his fascist friends regard as the absoute truth. The Jerry Avorns, Marcia Angells, Rothmans, etc inevitably endorse any conclusions that fit their ideology and refuse to subject their assertions to the scientific method. ( It is the very reason that the comparative effectiveness crowd relies on a rigged approach to evaluation: selecting only randomized trials with exclusion criteria that fail to control for variation in treatment effect and using meta-analyses to reach conclusions instead of generating hypothesis so as to reinforce the initial weakness of underpowered randomized trials. All conclusions will show no difference in benefit among competing therapies... )
To assert that patient groups are somehow "fake" because they receive industry funding raises the question of who made Rothman and George Soros the gold standard of probity? The ultimate measure of any individual or organization is the merit of their position, the contribution of their effort. Does receipt of money from a currency wrecker, who has spent money to weaken the state of Israel (Soros), who himself invests billions in biotech and drug companies, qualify for knighthood compared to receiving support from companies that commercialize medical knowledge, invest in scientific research, give away billions in free medicines. Soros -- and by extension -- Rothman and Blumenthal have profited from the profits of drug companies...
If Rothman succeeds in his campaign of intimidation it will not "purify" medicine and thereby improve the quality of care. There is no evidence of this cause and effect. On the contrary there is no scientific evidence to support this assertion. Meanwhile other countries and health systems are increasing the amount of collaboration with direct subsidies, increase patent opportunities, etc in order to promote innovation and retain scientific talent.
Rothman and his ilk are angy elites who should be shunned and attacked by the patient groups. Once the patient groups are silenced then advocacy for faster cures will die. What will happen next is fairly obvious. Soros, who stood by without feeling as Nazis confiscated the property of Jews, has picked his associates well.
A new research study from health-information company Wolters Kluwer Health reports that in the fourth quarter of 2008,
According to a story in today’s Wall Street Journal, “Higher co-payments required under health-insurance plans and other plan features helped boost the number of patients unwilling to pay for their prescriptions, according to the research.”
Why higher co-pays? Because insurance companies don’t want patients to fill prescriptions for on-patent medicines. The Journal writes that “… insurers are flexing their muscle and rejecting coverage for more prescriptions. Health plans denied 10.8% of brand-name prescriptions in the 2008 fourth quarter, a 21% increase from the first quarter in 2007.
Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.
Good for payers. Bad for everyone else – including employers.
"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.
As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."
The headline of that New York Times article was, "Health penny wise, medical pound foolish?
Indeed.
Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payers interpose themselves between doctor and patient, when prescribing decisions are made by accountants based on “cost-effectiveness” studies, health outcomes decline for the individual and costs go up for our health care system.
The 55 year old jogs, rides a racing bike, and eats carefully. As a result, he lives an almost pain free life. He is only occasionally afflicted with a sour stomach, for which each time his doctor prescribes a medicine against heartburn.
Luther himself hasn’t noticed his terrible pain at all. He looks as fit as anyone; he’s doing great. And if he wasn’t the chairman of the board of the same sickness fund by which he is covered as a patient, he might never have found out that his health situation had deteriorated so dramatically.
An asthma patient, who goes to the pneumonologist every second quarter and uses the conventional combination spray, provides a plus of €192 a year.
The diagnosis ‘psychological depression’ brings the sickness fund nothing. It’s better when the insured has a ‘light depressive episode,’ then there is almost €1000 extra.
WASHINGTON, D.C. (April 7, 2009) - Democratic and Republican party leaders and political operatives will discuss their differing perspectives on the challenges and opportunities associated with the comprehensive reform of the U.S. healthcare system during a keynote panel, titled "The Challenges and Opportunities Surrounding Healthcare Reform,” taking place Wednesday, May 20 from 12:00 – 1:45 pm at the Georgia World Congress Center during the Keynote Luncheon at the 2009 BIO International Convention.
Moderated by Susan Dentzer of The NewsHour with Jim Lehrer, the panel will include Senator Tom Daschle, Governor Howard Dean, Senator William H. Frist, M.D, and Karl Rove.
"This panel provides an opportunity to discuss and debate the best options and opportunities for the new administration as they move toward their goal of restructuring our nation's health care system,” said James C. Greenwood, president and CEO, BIO. "As the Obama Administration and Congress explore how to restructure the delivery of the nation's health care services, it is important that the biotech industry is involved in the debate.”
The panel will address the road to a new health care system in the United States, providing a preview to the debates expected to take place in Congress later this year. Panel members bring with them a vast array of experience in government service, from Congress to the Governorship and Chief of Staff to former President George W. Bush.
Great...that's exactly what we need. Spin from spinmeisters who will tell the assembled how to behave to get a "seat at the table." And I am sure they are all doing it for free. I hope BIO got a good deal on the car service at least...
And how does listening to the same stuff and talking points from the New America Foundation and Rahm Emanuel (at least as far as Daschle is concerned) going to insure that biotech is involved in the debate. Last time around biotech met face to face with President Clinton and the health proposal still called for comparative effectiveness reviews as a condition for reimbursement and use. Now it's a done deal and BIO is fine with it..... Have you seen those principles about "patient-centered" health care anywhere in the FCCER mission. Anyone?
I still think it is better to stand up for principles before getting a seat at the table....And it's a lot better to give politicians a piece of your mind than to have them lecture you about how to behave in The People's House... It is still ours...
If you like comparative effectiveness you’re going to love mental modeling.
In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.
Something to think about.
A Florida couple, both well into their 70s, go to a sex therapist's office.
The doctor asks, "What can I do for you?"
The man says, "Will you watch us have sexual intercourse?"
The doctor raises both eyebrows, but he is so amazed that such an elderly couple is asking for sexual advice that he agrees.
When the couple finishes, the doctor says, "There's absolutely nothing wrong with the way you have intercourse."
He thanks them for coming, he wishes them good luck, he charges them $50 and he says good bye.
The next week, the same couple returns and asks the sex therapist to watch again. The sex therapist is a bit puzzled, but agrees.
This happens several weeks in a row.
The couple makes an appointment, has intercourse with no problems, pays the doctor, then leave.
Finally, after 3 months of this routine, the doctor says, "I'm sorry, but I have to ask. Just what are you trying to find out?"
The man says,
"We're not trying to find out anything.
She's widowed and lives with a daughter so we can't go to her house. I'm widowed and live with my son and family so we can't go to my house.
The Holiday Inn charges $98. The Hilton charges $139. We do it here for $50, and I get $43 back from Medicare.”
At just before 5pm last Friday (April 3), the FDA posted 14 DDMAC warning letters. They can all be found here:
Click Here to Read the Letters
First of all, kudos to the agency for posting them so swiftly. The letters were all released on April 2 and posted on April 3.
DDMAC, timely? What’s wrong with this picture? Or, if you prefer, what’s right?
The next item to consider is the contents of the letters. They all deal with the same topic, “sponsored” Google links.
DDMAC consistent? What’s wrong with this picture? Of, if you prefer …
Consistent because all of the letters not only deal with the same issue of sponsored links, but address them in more or less the same way. Let’s take the letter to Bayer for example:
Here’s how the letter begins:
“The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored links for Mirena overstate the efficacy of the drug. Furthermore, all of the sponsored links fail to use the required established name. Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).”
While the particulars for each of the other 13 letters differ, the basic theme is the same, that the “sponsored links” are not in compliance because they are “misleading” – making “representations and/or suggestions” that DDMAC feels are out of compliance, and fail to present the appropriate risk information.
Now, as all you weathered FDA cowhands know – when it comes to DDMAC letters (and every other piece of FDA communication) – it’s very important to understand what’s in the letter as well as what is not.
These letters are about sponsored links. What does that mean? Sponsored links, as the DDMAC letters illustrate, are those links in the “sponsored” section of a web search (in the case of Google, these are the search results that appear on the upper right hand side of the page). Never more than a few lines, they are teasers. And, not to put too fine a point on it – they are paid for product marketing messages. They are advertisements.
The DDMAC letter to sanofis-aventis is particularly instructive on this point:
“Omission of Risk Information
Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug. Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the
materials. The sponsored links present the following claims (emphasis in original):
* PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD. See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com … “
So, DDMAC is making the point that sponsored links such as these are being considered as “reminder ads” gone wild.
Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.
Podium policy via Warning Letters is not a replacement for clear and concise guidance.
Okay, so wither “guidance?” Consider some official agency direction that is already on the books:
Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
Click Here to Read the Report
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
It’s not a leap of faith to understand the implications (and applications) of this relative to the concept of sponsored Google links.
For example, what about the concept of “clicking thorough” to full risk/benefit information? Let’s look to the GSK letter for that one. DDMAC writes:
“We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.”
Now, here’s where it becomes less clear. How will this impact regulatory perspectives on branded product websites? What about third party websites that have been constructed with grants (unrestricted or otherwise) from interested parties? What about links and websites for devices and diagnostics?
What about predictability?
Well, that’s harder than it sounds because regulators love ambiguity. Ambiguity is power. And that’s particularly true for DDMAC issues that quickly bump up against the First Amendment. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.
My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters. What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee.
(In fact, it should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion.)
Here’s something that isn’t opinion -- sending out Warning Letters isn’t guidance – it’s punitive regulatory action. It’s FDA acting tough without putting in the time and brainpower to explain how to address the perceived problem. That’s not what we need. That doesn’t advance the pubic health.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.
Predictability is power in pursuit of the public health.
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.
