Latest Drugwonks' Blog
For the growing chorus of politicians who think that Medicare Part D should look more like the benefits offered by the VA, consider the following …
(1) A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA National Formulary’s drugs are more than 8 years old, with just 19% of its prescription drugs approved since 2000 and 38% of prescription drugs approved between 1990-2000.
(2) The VA imposes an automatic one-year hold on most new medicines while it “studies” the effects.” For many important medicines such as Gleevec for stomach cancer or drugs for mental illness, patients must “fail first” on a cheaper drug before they get a breakthrough.
(3) Lichtenberg found that veterans’ life expectancy increased significantly before the National Formulary was introduced (between 1991-1997)) but did not increase and may have declined after the National Formulary was introduced (between 1997-2002). Yet, the life expectancy of all U.S. males increased both before and after 1997.
Remember the character-assasination job that Alicia Munday did awhile back in the Seattle Times? Well here’s what one of their own editorial writers had to say about it. And all I can add is “well done!”
Our Man at the F.D.A.
The Times’ page one story on Scott Gottlieb, the Wall Street analyst hired by the Food and Drug Administration is an editorializing story — a story with a message. We can tell the story straight — and our reporter, Alicia Mundy, tells it pretty straight, but the premise of it, the definition of it as a story, carries a message of the fox guarding the henhouse or “regulatory capture,” meaning an industry influencing its regulator.
Our reporter has put in a resume of Mr. Gottlieb, and so we can have a rough measure of his attachments to Wall Street. He ran a Forbes investment newsletter for about half a year, also participating as a policy guy at the American Enterprise Institute, a right-of-center policy shop. He has previously worked for the FDA in medical policy under the Bush administration. He has worked for George Gilder, who writes about investments and policy from a pro-technology view. He has been a medical internist at a hospital. In the Clinton years he wrote for the Journal of the American Medical Association and worked in the investment firm Alex. Brown. His degree is in economics.
My question is: For a policy job, would it have been preferable to hire a person who had been in the bureaucracy for an entire career? Certainly there are people like that, and probably lots at the FDA. Probably the lifetime regulators are more pro-regulation than Mr. Gottlieb will be. The unspoken assumption of this story is that that’s what the public should want.
It’s not what I want. I want innovation, I want information, and I want choice. I want new drugs to be tested and reviewed, but I don’t want the system to be so safety-conscious that I can’t get the drugs I need. The fact is, people are suffering and dying now. New medicines may be able to help them. If you insist on a drug-approval system of near-zero risk, you delay the new medicines and more people suffer and die. You can die from taking a drug that should have been studied longer and you can die from not getting a drug that should have been approved earlier.
There is also the question of whether people who are sick should be allowed to make these choices themselves. If you have cancer, and it’s going to take five years to review a new drug to a zero-risk standard, maybe you don’t want to wait five years. Maybe you want the drug now. I think the system should allow that — and (judging from one newspaper article) Mr. Gottlieb is more likely to consider that point of view than someone who has been a regulator all his adult life.
Bruce Ramsey, Editorial Writer, The Seattle Times
I’ll be speaking in Brussels on how Europe can begin to embrace and then help to educate the empowered 21st century health care consumer. Here’s more information …
The Amigo Society invites you to discuss:
“Consumers and Health Information: Is knowledge really power?”
Featuring:
Peter J. Pitts
Former Associate Commissioner
Food and Drug Administration (USA)
Commentators:
James Copping,
European Commission
(High Level Pharmaceutical Forum)
Colin Webb
Vice-President, European Patients’ Forum
A recent consumer survey in Europe asked people in eight old and new EU member countries what reforms would most likely increase their quality of care. In every nation, by a large margin, “giving patients more information about their illness” was the preferred solution.
Health care education is the consumer’s Rosetta Stone. Public policy institutes, pharmaceutical companies, health care professionals and patient advocates, along with government must be allied in the drive to deliver information to patients, for it is, ultimately, about saving lives and saving our health care systems. Moreover, increasing information to patients will improve disease awareness and aid in defeating patient non-compliance estimated to cost billions of euros a year in increased emergency room visits, unnecessary surgeries, expensive hospital stays, and lost productivity.
To debate and discuss the value of these arguments, please join us on:
Tuesday 21 March 2006
7-8:30 pm (cocktails to follow)
Hotel Amigo, Rue de l’Amigo 1-3, Brussels
To RSVP visit
http://www.stockholm-network.org/conferences/events/signup.php
Bob Goldberg asks a tough question …
Is it suprising that the return of the MS drug Tysabri was scarcely covered by the mainstream media or that Senator Charles Grassley — who just a week ago was red-faced about the dangers of ADHD drugs — did not hail the fact that a drug demonstrably effective for so many patients was once again available? Media coverage of the withdrawal of Tysabri outweighed the coverage of it’s return by 6-1… and while the articles about the horrors of the drug ran on and on and were on the front page of major papers, those about the FDA advisory panel recommending that it be brought back to market were under a paragraph and tucked into the back of the business section. The New York Times and the Boston Globe were notable and laudatory exceptions to this trend. Shame on the Wall Street Journal for sensationalizing the withdrawal and then consigning its return to a few sentences a year later. “Hate the drug companies” bias persists.
This bias harms patient health and amounts to fear mongering on the part of the media. When editors decide that the return of life enhancing drug is less important than it’s removal from the market — that a public has less of a right to know about the former than the latter — then the legitimacy of the media as an arbiter of what is in the public interest should be openly and vociferously debated. And so should the judgement of the politicians that see the media as their platform.
On February 23, Bob Goldberg blogged on the half-truths Liberally sprinkled throughout a report issued by the Democrat minority staff of the House Government Reform Committee. Dr. Goldberg’s argument was based 100% on fact. The report by the minority staff was based on politics, sound bites, and fuzzy math. As my grandmother used to say, a half truth is a whole lie.
Now it seems that Democrats in Congress are taking the same half-truth strategy, customizing its fallacies to fit local constituencies and taking it on the road. Consider the case of Northern California.
Here’s how the San Francisco Chronicle reported it …
Bay Area Democrats in Congress released a survey earlier this week concluding that prices for 10 top-selling drugs purchased through Medicare were higher than those paid by Canadian consumers or Costco customers … For its part, the study by Bay Area Democrats found the average costs of 10 common brand-name drugs offered by 10 plans in the Bay Area were 75 percent higher than prices negotiated by the federal government for agencies such as the Veterans’ Administration, 60 percent higher than prices in Canada, nearly 5 percent higher than prices available online through Drugstore.com and almost 2 percent higher than those at warehouse club retailer Costco.
Yep — it’s the exact same story that ran in the national press in late February. How soon the media forgets. And I fear it is selective memory loss.
So let me repeat what Bob said only a few short weeks ago — the Bay Area Dems deliberately omitted drug plans that allow patients to pay a fixed low price for all the drugs they survey. There are many drug plans that allow consumers to pay $30 for a month’s supply of each drug (or $25 a month if purchased through mail order). All these prices are substantially lower than any of the average prices cited by the Democrat staff. Not decimal dust.
Maybe we should call these representatives the new Bay City Rollers.
FYI — I did not write this, I am only sharing.
Wonder Drug Inspires Deep, Unwavering Love of Pharmaceutical Companies
THE ONION
March 6, 2006
NEW YORK — The Food and Drug Administration today approved the sale of the drug PharmAmorin, a prescription tablet developed by Pfizer to treat chronic distrust of large prescription-drug manufacturers.
Pfizer executives characterized the FDA’s approval as a “godsend” for sufferers of independent-thinking-related mental-health disorders.
PharmAmorin, now relieving distrust of large pharmaceutical conglomerates in pharmacies nationwide.
“Many individuals today lack the deep, abiding affection for drug makers that is found in healthy people, such as myself,” Pfizer CEO Hank McKinnell said. “These tragic disorders are reaching epidemic levels, and as a company dedicated to promoting the health, well-being, and long life of our company’s public image, it was imperative that we did something to combat them.”
Although many psychotropic drugs impart a generalized feeling of well-being, PharmAmorin is the first to induce and focus intense feelings of affection externally, toward for-profit drug makers. Pfizer representatives say that, if taken regularly, PharmAmorin can increase affection for and trust in its developers by as much as 96.5 percent.
“Out of a test group of 180, 172 study participants reported a dramatic rise in their passion for pharmaceutical companies,” said Pfizer director of clinical research Suzanne Frost. “And 167 asked their doctors about a variety of prescription medications they had seen on TV.”
Frost said a small percentage of test subjects showed an interest in becoming lobbyists for one of the top five pharmaceutical companies, and several browsed eBay for drug-company apparel.
PharmAmorin, available in 100, 200, and 400-mg tablets, is classified as a critical-thinking inhibitor, a family of drugs that holds great promise for the estimated 20 million Americans who suffer from Free-Thinking Disorder.
Pfizer will also promote PharmAmorin in an aggressive, $34.6 million print and televised ad campaign.
One TV ad, set to debut during next Sunday’s 60 Minutes telecast, shows a woman relaxing in her living room and reading a newspaper headlined “Newest Drug Company Scandal Undermines Public Trust.” The camera zooms into the tangled neural matter of her brain, revealing a sticky black substance and a purplish gas.
The narrator says, “She may show no symptoms, but in her brain, irrational fear and dislike of global pharmaceutical manufacturers is overwhelming her very peace of mind.”
After a brief summary of PharmAmorin’s benefits, the commercial concludes with the woman flying a kite across a sunny green meadow, the Pfizer headquarters gleaming in the background.
PharmAmorin is the first drug of its kind, but Pfizer will soon face competition from rival pharmaceutical giant Bristol-Myers Squibb. The company is developing its own pro-pharmaceutical-company medication, Brismysquibicin, which will induce warm feelings not just for drug corporations in general, but solely for Bristol-Myers Squibb.
“A PharmAmorin user could find himself gravitating toward the products of a GlaxoSmithKline or Eli Lilly,” BMS spokesman Andrew Fike said. “This could seriously impede the patient’s prescription-drug-market acceptance, or worse, Pfizer’s profits in the long run.”
“Brismysquibicin will be cheaper to produce and therefore far more affordable to those on fixed incomes,” Fike added.
The news of an affordable skepticism-inhibitor was welcomed by New York physician Christine Blake-Mann, who runs a free clinic in Spanish Harlem.
“A lot of my patients are very leery of the medical establishment,” Blake-Mann said. “This will help them feel better about it, and save money at the same time.”
PharmAmorin’s side effects include nausea, upset stomach, and ignoring the side effects of prescription drug medication.
Europe is today where FDA was two years ago. But we’re standing still while the WHO is moving forward. It’s time for some trans-Atlantic harmonization.
CONCLUSIONS AND RECOMMENDATIONS OF THE
WHO INTERNATIONAL CONFERENCE ON COMBATING COUNTERFEIT MEDICINES
DECLARATION OF ROME
18 FEB 2006
The participants of the WHO International Conference
‘Combating Counterfeit Drugs: Building Effective International Collaboration’,
gathered in Rome on 18 February 2006
DECLARE
1. Counterfeiting medicines, including the entire range of activities from manufacturing to providing them to patients, is a vile and serious criminal offence that puts human lives at risk and undermines the credibility of health systems.
2. Because of its direct impact on health, counterfeiting medicines should be combated and punished accordingly.
3. Combating counterfeit medicines requires the coordinated effort of all the different public and private stakeholders that are affected and are competent for addressing the different aspects of the problem.
4. Counterfeiting medicines is widespread and has escalated to such an extent that effective coordination and cooperation at the international level are necessary for regional and national strategies to be more effective.
5. National, regional and international strategies aimed at combating counterfeit medicines should be based on:
a) Political will, adequate legal framework, and implementation commensurate to the impact of this type of counterfeiting on public health and providing the necessary tools for a coordinated and effective law enforcement,
b) Inter-sectoral coordination based on written procedures, clearly defined roles, adequate resources, and effective administrative and operational tools,
c) Creating an awareness about the severity of the problem among all stakeholders and providing information to all levels of the health system and the public,
d) Development of technical competence and skills in all required areas,
e) Appropriate mechanisms for ensuring vigilance and input from healthcare professionals and the public.
6. The WHO should lead the establishment of an International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of governmental, non-governmental and international institutions aimed at:
a) Raising awareness among international organizations and other stakeholders at the international level in order to improve cooperation in combating counterfeit medicines, taking into account its global dimensions
b) Raising awareness among national authorities and decision-makers and calling for effective legislative measures in order to combat counterfeit medicines
c) Establishing effective exchange of information and providing assistance on specific issues that concern combating counterfeit medicines
d) Developing technical and administrative tools to support the establishment or strengthening of international, regional and national strategies
e) Encouraging coordination among different anti-counterfeiting initiatives.
The IMPACT shall function on the basis of existing structures/institutions and will in the long term explore further mechanisms, including an international convention, for strengthening international action against counterfeit medicines.
OOOOOOOOOOOklahoma, where the drugs comes sweepin’ in from Spain.
And Latvia and Crete, can be discete
While the parallel traders all will gain.
OKLAHOMA CITY — The Oklahoma Senate on Monday passed a bill that would allow state pharmacists and wholesale drug distributors to reimport prescription drugs from Canada, Switzerland and European Union member states.
The bill also would require the Oklahoma State Board of Pharmacy to certify foreign suppliers in those countries to distribute prescription drugs within the state, provided they meet certain conditions such as allowing inspections of their facilities and reviews of their safety protocols by the board.
The bill would become effective July 1. Under the measure, the state Department of Health would establish and maintain a prescription drug Web site by Jan. 1, 2007, to allow residents to buy prescription drugs online.
A similar bill has passed out of an Oklahoma House of Representatives committee and will proceed to the floor for a vote.
Dr. Bob Goldberg on Dr. Andy Von Eschenbach …
Andy Von Eschenbach has only one enemy: disease. He has beaten in personally and as physician and administrator proven to be a powerful and compassionate advocate for faster cures and better science at NCI and now at the FDA. Holding up his nomination as the next commissioner is like holding up progress against illness. Holding him and his appointment hostage to politics will only delay the necessary changes the FDA is seeking that will make drug evaluation as scientific and as cutting edge as the science shaping drug discovery. Just as a drug should not be held up for political purposes, nor should the nomination of a critical public health position be delayed because of election year posturing from either side of the aisle.
Will President Bush nominate Andy Von Eschenbach to be the next commissioner of the FDA? It would be a smart choice. Now’s the time to put aside partisanship and get this done with all due speed. A confirmed Commissioner must be everyone’s Plan A.
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.
