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All three profit from promoting this position. Goozner peddles his wares via book sales, lectures, etc. And Lurie and Wolfe have co-authored something called Worst Pills, Best Pillsm which ,I kid you not , was once offered as a the perfect holiday gift.
"All three have or had direct influence on the FDA's decisions on medicines and establishing the risk-benefit tolerance of the agency. Gooz and Wolfe were or are on FDA advisory committees. Lurie is now in the FDA's Office of Policy in Peggy Hamburg's shop.
Lurie, a physician, will be the third person with ties to Public Citizen to be engaged by the FDA. Sidney Wolfe, former head of Public Citizen's Health Research Group and editor of Worst Pills, Best Pills (http://worstpills.org/; Nat. Biotechnol. 26, 149, 2008) has been a member of the FDA Drug Safety and Risk Management Advisory Committee since 2008. Also Joshua Sharfstein, the FDA's current principal deputy commissioner, has early ties to Public Citizen from an internship in 1992. Before joining the FDA, Sharfstein developed a reputation as a reformer and an industry critic through his advocacy work in the field of HIV/AIDS and his efforts to limit marketing of pediatric cold remedies."
No conflict or coverage thereof?
Only sweet sounds are heard about their appointments:
“It can't hurt to have smart people—who may be a little controversial—in government. People [in government] can go into this deep inertia of making only small, incremental movement...you can take [Lurie's] energy and his desire to improve the process to help move things forward.”
Which brings me to the comments of Wolfe and Goozner and the manufactured hit job they help lead against another smart, controversial person, Scott Gottlieb, who is a real doctor who sees real patients, unlike Wolfe or Goozner.
Here's what Goozner said about Scott's appointment to Alicia Mundy, who is now the go to source for those inside FDA seeking to make life miserable for Janet Woodcock, John Jenkins and others:
"I've never heard of anything like this," said Merrill Goozner, a director at the liberal Center for Science in the Public Interest.
"If he's had dealings regarding companies whose products are up for review at the agency, it strikes me as a potential conflict of interest. You want a barrier between the regulated and the regulators. It's fundamental," Goozner said.
What about intellectual bias? Note how the Gooz cut himself yards of slack, with Mundy giving him room to do so. I guess neither knew or cared about the FDA's equally strict restriction on using one's position to skew or bias proceedings to fit a particular, uh, narrative. Or book sales. Or continued existence as Project Director at certain advocacy groups...Or whatever:
But intellectual bias is a big problem. Bigger than financial conflicts because, as Aaron Wildavsky observed in Risk and Culture, the adherents of organizations that individuals such as Lurie, Goozner, Wolfe and Alicia Mundy have worked for and work for need enemies, corporate enemies to unify and motive a base sharing a deep cultural bias about the inherent dangers of technology. To suggest this bias does not exist or is an articulation of objective reality is to cede control of the political and social institutions that regulate all human activity to the aforementioned since their goal is not this regulation or that, but to "break the stranglehold which they consider such interests have on society." tinyurl.com/33vyzj5
All the more reason that the FDA in it's small way has sought to put a leash on such totalitarian behavior:
"Within the Center for Drug Evaluation and Research, there are provisions stating that members participating on advisory panels should be free from intellectual bias. According to the FDA document, the appearance of intellectual bias is an issue if the member is identified as a "primary advocate" or is "so strongly associated with a position on a matter" that concerns could be raised about his or her impartiality and objectivity.
Also, intellectual bias may exist if "statements of record have been made by that member concerning an issue to be considered by the committee that draw conclusions or strongly appear to draw conclusions to a degree that would appear, to informed experts, to preclude an impartial and objective evaluation of information on that matter presented to the committee." These statements could be taken from legal cases, other regulatory agencies, or even from the media.
As Jenkins told heartwire last week, members are welcome to bring differing perspectives and to ask tough questions, "But at the same time, we want the committee members to come to the table with an open mind, so they can give us advice based on the data, the presentations, and the discussions that are held at the committee meeting itself."
www.theheart.org/article/943511.do
And finally here is Lurie essentially shooting himself in the foot by acknowleding that financial "conflicts" are easily spotted whereas intellectual bias can be disguised as just scientific disagreement:
"Frequently, one hears that there are both financial and intellectual conflicts of interest; somehow this argument is offered as evidence to downplay the importance of the financial conflicts. While intellectual conflicts are important, they can readily be distinguished from financial ones. Financial conflicts of interest are extrinsic to the scientific endeavor, whereas intellectual conflict is the very way science moves forward. Financial conflicts can occur at variable levels – some people have them, some people don’t – and they can be quantified, whereas intellectual conflicts are ubiquitous and not susceptible to quantification in the same way. Moreover, in the context of debate on an advisory committee, for example, it is unlikely that the financial conflict information will naturally emerge, whereas it is likely that any relevant intellectual one will. There are relatively straight-forward methods to alleviate financial conflicts, whereas it’s not nearly as clear how one should approach intellectual conflicts. Finally, our legal system has long recognized the distinctions between the two.
brodyhooked.blogspot.com/2008_03_01_archive.html
Indeed, it has. The intellectual bias is much more problematic:
"Two of these definitions are: an individual has a COI when there is a conflict between his/her private or institutional interest and his/her official duties in a position of responsibility or trust; or, an individual is in conflict if he/she owes a duty of loyalty or responsibility to two distinct entities or individuals, both of which are likely to be affected by the scientific activity in which the individual is engaged. The term "interest" can refer to a financial (i.e., employer, employee, consultant, stockholder, investor, etc.) or a non-financial interest/relationship (i.e., family member, mentor, mentee, professional colleague, co-author, etc.). Most existing COI policies address financial but not non-financial conflicts of interest; however, non-financial conflicts of interest are equally common and important, and they warrant, and will likely receive, more attention and a higher degree of scrutiny in the future."
toxsci.oxfordjournals.org/cgi/content/full/87/1/11
The U.S. Trade Representative's most recent report on global intellectual property rights suggests compulsory licensing may be receding somewhat as a worry for pharmaceutical companies, but inadequate data protection remains a strong concern.
The USTR's 2010 Special 301 Report, which reviews U.S. trading partners' protection and enforcement of intellectual properties, cited 19 countries (the same number as last year) where there appears to be a lack of adequate protection against unfair commercial use and unauthorized disclosure of test or other data generated to obtain approval of pharmaceutical products.
The USTR has faced pressure from Congress and public advocacy groups to modify its stand on compulsory licensing and other measures advocated by the pharmaceutical industry.
Representative Henry Waxman (D, CA), chair of the House Energy and Commerce Committee, sent a letter to U.S. Trade Representative Ron Kirk advocating that the Special 301 Report support international access to medicines.
"In recent years, despite the United States' commitment to the Doha Declaration, Special 301 reports have been used to pressure developing countries to adopt pharmaceutical protection rules that go beyond their obligations under the TRIPS agreement, limiting the scope of actions such countries could take to promote access to medicines," Waxman wrote.
Mr. Waxman also said he was concerned that anti-counterfeit measures may be used to enforce patents. Looks like the Chairman has Jamie Love on speed dial.
Three years and more than 80,000 deaths ago I wrote in these pages about a travesty that had occurred at the Food and Drug Administration.
In May of 2007 two unique cancer therapies for the treatment of prostate cancer and osteosarcoma (a type of bone cancer) came under review at the FDA on the same day. Both the new agent for prostate cancer, Provenge, and the new agent for osteosarcoma, Mepact, had shown the ability to prolong lives to a significant degree. And both drugs were summarily rejected. Provenge and Mepact were tossed back to the companies developing them with the directive to do more clinical studies.
This was easy enough for Provenge, due to the return on the risk of investment possible with a new prostate cancer drug and the large number of men with the disease available for another clinical trial. The Dendreon company, makers of Provenge, worked as quickly as possible to redo their already successful trial. The results of the new trial turned out the same as the original, and the drug was finally approved by the FDA last week.
In the three years that it took to duplicate what was already known, upwards of 80,000 men lost their lives to prostate cancer. This is equal to the number of men killed in combat in the Korean, Vietnam and Iraq wars combined.
Those FDA staffers who had a role in preventing the approval of Provenge in 2007 will have to live with this sin of omission. But at least now a powerful new weapon is available to help prostate cancer patients.
Not so for those of us in the American sarcoma community waiting for Mepact. Osteosarcoma effects only 900 Americans, mostly children and young adults, each year. The FDA's stunningly cavalier demand for another clinical trial for Mepact was made with the full knowledge that the repeat effort would require about 900 new patients.
Imagine if a clinical trial for a new asthma or diabetes drug required every single patient in the country to be included not once but twice and you will begin to appreciate the profound predicament those of us in the rare-disease community face when it comes to the FDA's irrational standards.
Recently, hope has emerged that a more humane approach might be taken at the FDA to approve new drugs for exceedingly rare diseases. In an amendment to the 2010 FDA Appropriations law, Sen. Sherrod Brown (D., Ohio) and Sen. Sam Brownback (R., Kan.) inserted language that requires the FDA to explain the unfairness of its policies, which have resulted in about 200 treatments for the over 8,000 diseases categorized as rare.
In March, the new FDA Commissioner, Dr. Margaret Hamburg, appeared before the Senate to discuss the issue. In emotionally moving testimony about her own experiences as a doctor dealing with patients in desperate need of new therapies, she promised "innovative if not transformative" approaches to the problem, saying that "new regulatory pathways could be developed . . . to catalyze activity in areas where there are limited markets." She added that this issue is "of the highest priority in the White House."
In Europe, such creative pathways for regulatory approval exist, and they have resulted in the approval for Mepact in the EU. Mepact is the poster child for all that is wrong at the FDA regarding treatments for rare diseases, and many have hope that Dr. Hamburg is the right leader to address this health crisis.
The approval of Provenge, a revolutionary agent that taps the body's own immune system to fight cancer, ushers in the dawn of the age of cancer immunotherapy. Mepact similarly stimulates the immune system to prolong osteosarcoma patients lives, and it is doing so as we speak for children in Europe with this bone cancer.
Oncologists in the FDA Center for Drugs should show penance for their fatal error and join their European colleagues in approving Mepact without the need for another 10-year long clinical trial. The Americans currently living with osteosarcoma can't wait any longer.
Dr. Thornton worked as a medical officer at the FDA for six years. He is the president of the Sarcoma Foundation of America, which has received modest contributions from a U.S. subsidiary that is owned by the makers of Mepact.
Senate Majority Leader Harry Reid is campaigning in Nevada for re-election and continues to tout the health care law. He recently said, “The most important thing we've done for the country and the world is health care.”
Last month, Friedman posited that passage of the health care law strengthened President Obama’s hand in foreign policy:
“Our enemies surely noticed, too. You don’t have to be Machiavelli to believe that the leaders of Iran and Venezuela shared the barely disguised Republican hope that health care would fail and, therefore, Obama’s whole political agenda would be stalled and, therefore, his presidency enfeebled. He would then be a lame duck for the next three years and America would be a lame power.”
Yes, because I’m sure our health care system is an issue very dear to Iranian president Mahmoud Ahmadinejad.
A majority of Americans stood opposed to the law. More than 20 states have joined in a lawsuit against the federal government challenging the law, with particular emphasis on the individual mandate. And polls continue to show no improvement in public opinion of the health care law.
In this country we don’t pass life-changing domestic legislation so that a president may convey political strength overseas.
With that said, it’s highly doubtful that the legislation had the impact Friedman suggests.
Fidel Castro applauded the health care law as “a miracle.” Castro also said, “It is really incredible that 234 years after the Declaration of Independence ... the government of that country has approved medical attention for the majority of its citizens, something that Cuba was able to do half a century ago.”
Here are some recent pictures smuggled out of Cuba highlighting that medical attention Cubans receive.
After praising passage of health care, Castro then attacked President Obama as a “fanatic believer in capitalist imperialism.”
The goodwill didn’t last long.
Now the World Health Organization Director-General Margaret Chan just returned from North Korea with words of admiration for their health care system. Apparently North Korea does an excellent job of keeping its citizens thin.
“They have something which most other developing countries would envy,” said Chan.
Who would have thought?
Then again, most of the world has been praising Cuba’s health care system for the last 40 years.
At any rate, the point here is that we should not decide health care policy in the US based on the misguided perceptions of our system by other countries. And we should most definitely not use domestic policy as a means of strengthening our influence on foreign policy matters.
Senator Reid and Thomas Friedman ought to know better.
The lesson: Correlation is not causation.
The video is worth checking out:
Arkansas Senator Mark Pryor went on the attack in front of the cameras accusing Goldman Sachs executives for “betting with other people's money and other people's futures.”
Senator Pryor failed to recognize the blatant hypocrisy in his accusation.
Here is a United States Senator who voted for the health care bill before he voted against it.
In voting against the reconciliation bill in March, Pryor acknowledged the adverse impact of the legislation:
"I believe the package falls short of the criteria of making health care more affordable, reliable, and accessible. As more and more details of the package were released, I spent considerable time weighing the benefits and drawbacks to Arkansas. In the end, I believe this legislation is a step we don’t need to take."
And this man dares lecture financial sector executives?
Where was his concern for “other people’s money” and “other people’s futures” when he voted in favor of the Senate health bill last year?
Mind you, Pryor had a fiduciary duty to his constituents to read and understand this far-reaching and costly legislation. He failed to do that and instead gambled with one-sixth of the US economy.
Some might argue that is far worse than any transgressions by Goldman Sachs.
At the BIO conference yesterday I had the pleasure of chairing a panel entitled, “Advertising or Freedom of Expression? Cross-Border Communications and the New World Order.” And a high-powered panel it was. I was joined by Jack Bierig (Sidley Austin), Marie Kennedy (Baxter) and Ray Kerins (Pfizer).
An audio recording of the panel can be found on the BIO site (www.bio.org).
Here are my remarks:
If healthcare is a “right,” then is access to information about healthcare also a right?
Well, where you stand depends on where you sit and, for biopharmaceutical companies, it determines how you act.
And nowhere at BIO 2010 will you find a more lively, engaging, and expert panel to debate this timely and crucial issue than right here and right now. Welcome to BIO con brio.
What’s going on in the US? Does the First Amendment still count? What’s going on in the EU? Does “information to patients” really mean anything? In the complex and hyper-bureaucratic world of Brussels, is reform going anywhere beyond just words?
And when it comes to healthcare communications, wither social media on either side of the pond?
Let’s start with a look at what’s going on in Europe.
The situation “over there” can be summed up by James Copping of the European Commission’s Enterprise & Industry Directorate. According to Mr. Copping:
“We have an unsustainable mix of regulations, and the legislation on advertising was largely drafted in the 1980s, before the Internet became a daily feature of many people’s lives.”
In 2006 I debated Mr. Copping. He said, “We must find new ways to regulate healthcare information to patients.” I then suggested that a better way to frame that statement would be to say that “the EU needs to find a better way to facilitate healthcare information to patients.” To which Mr. Copping replied, “Yes, that’s right.”
Well, that was then and this is now. But before we see what’s sprouting in pursuant to the shifting of ITP authority from Enterprise & Industry to DG SANCO, let’s turn our attention northwards to Denmark for a disturbing twist and a reminder that “free speech” means something very different in Europe then it does here in the US.
In 2003, Danish journalist Frede Damgaard published information on his website about Hyben Total, a treatment for a wide range of conditions—including gout, kidney and bladder disorders, sciatica, diarrhea, and diabetes. The Danish national regulator in 1999 refused it a marketing authorization. It is still sold as a medicine in Sweden and Norway.
Mr. Damgaard’s positive description of Hyben Total’s effects on the symptoms of gout and arthritis led to his being prosecuted in the Danish courts on the grounds that it constituted advertising of a medicinal product whose sale was not authorized in Denmark – and the Danish court specifically cited Article 86 of European Union Directive 2001/83/EC, which defines the concept of medicines advertising.
Mr. Damgaard appealed to the European Court of Justice, claiming that his discussion of Hyben Total could not be held to constitute advertising since he had no interest in selling the product, and also that the court decision contravened European Union protections of freedom of expression. And the ECJ agreed.
According to the opinion handed down by the ECJ Advocate General, “a lack of connection between the author of the information and the sellers or manufacturers of the medicinal product and the non-commercial or non-industrial nature of the activity of that independent third party may…be strong indications that a message does not have promotional content.”
The advocate general added that this was not an isolated case; similar situations had arisen recently over statements about melatonin in Spain, and in the Czech Republic, over a collection of media features entitled “Yesterday Viagra, today Cialis.”
The advocate general concluded that it’s up to individual EU member states “to ensure the correct balance between, on the one hand, the objectives of protecting health and promoting the rational use of medicinal products and, on the other, the right of the party concerned to freedom of expression, taking into account the special protection afforded to the party concerned, if it is established that he is a journalist.”
But how do you “establish” who is and who is not a “journalist?”
Not a complete victory for the Fourth Estate and uncomfortable silence from the court about free speech for non-journalists. What about free speech for physicians and patients and, yes – even biopharmaceutical companies?
And so we return to Brussels.
Recent reports have spoken about "renewed optimism" that the EU’s proposed legislation on allowing drug makers to provide information to patients on prescription-only medicines will again start moving through its treacle-like legislative process. The latest thinking, however, is strongly focused on the rights of patients to receive such information, rather than industry's right to disseminate it.
That’s an interesting and important finesse – the rights of a patient to the information but no “right” for industry to provide it. Hm.
Suggested amendments to the most current consultation document emerged on March 10th from M.E.P. Christofer Fjellner, who’s reviewing the proposed legislation for the EU parliament's Committee on the Environment, Public Health and Food Safety.
Fjellner’s position is that information on pharmaceuticals should only be made available to patients who are actively searching for it. In other words, information should be "pulled" by the patient rather than "pushed" by industry.
Fjellner believes that companies should not be allowed to provide information on prescription-only medicines on television or in newspapers or magazines. He believes the Internet is the appropriate medium for providing information to patients.
And maybe he's right -- but is there really a difference?
If a pharmaceutical company makes available information on a web page – why is that different than making it available in other media? And what about patients who do not have access to the Internet -- what about their rights?
And what are the ramifications for social media? “The Internet” is, after all, only the substrate.
On the upside, Fjellner is calling for patient organizations to be actively involved in implementing the new legislation, working to help create guidelines and a code of conduct. Bravo.
But needless to say (and important to share) is the hue and cry this last suggestion elicited from the anti-ITP crowd who immediately objected to the participation of patient groups because of the financial support they receive from “interested parties. And you know who you are.
The environment committee will vote on the patient information proposals this June. After that a plenary vote of all European Members of Parliament will be held in September. It will then go to the Council of the EU for further consideration. Process as proxy for action.
The battle lines are drawn. Brussels moves in mysterious ways and “consensus” is a very un-American concept.
EU president Herman Van Rompuy is often referred to as “Haiku Herman” frequently ending his speeches with a composition of this own. And so, in keeping with the transatlantic nature of the topic at hand, let me do the same:
Health information.
When will Brussels move forward?
We watch and await.
Thank you.
USP also means "Unique Selling Proposition."
Pleased and proud to share the news that CMPI senior fellow Tim Franson, MD has been elected President of the USP Convention.
As most of you already know, USP is a scientific nonprofit organization that sets standards for the quality of medicines, dietary supplements and food ingredients. USP’s drug standards are enforceable by the Food and Drug Administration in the United States and USP standards are used in more than 130 countries around the world. USP standards designate the quality, purity, strength and consistency of a medicine, food ingredient or dietary supplement for the benefit of patients, practitioners, manufacturers, and consumers.
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.
