Latest Drugwonks' Blog
According to a new survey, US doctors do not believe industry funding significantly biases their continuing medical education -- and they are unwilling to pay for “impartial sponsorship.”
Dr. Jeffrey Tabas, an emergency physician at the University of California, San Francisco, surveyed attendees at five CME courses delivered by the International AIDS Society-USA, which receives industry funding.
Less than half thought paying higher registration fees for CME activities would make sense and only 15 percent would like to see industry funding completely removed.
"Because they feel in general there is not a lot of bias, they are not willing to pay to reduce it," said Tabas.
Drugmakers seeking FDA approval for biosimilars will pay application fees similar to charges for brand-name medicines.
The Food and Drug Administration plans to break down the cost to review so-called biosimilars into separate payments with more money charged up front during development, according to a proposal released today. The fees will be assessed annually and followed by application charges, establishment and product fees required for all drugs.
“Given that the approval pathway for biosimilar and interchangeable biological products is new, FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application,” the agency said in its Federal Register notice.
The FDA’s proposal covers fiscal years 2013 to 2017, and comments will be accepted on the plan until June 9.
A state bill making its way through Sacramento would ban the practice of requiring patients to pay a percentage of drugs that fall into so-called specialty tiers. These drugs are necessary for millions of patients nationwide who suffer from cancer, multiple sclerosis, scleroderma, rheumatoid arthritis and other auto-immune diseases.
The bill, introduced by Assemblywoman Fiona Ma, D-San Francisco, would place a $150 out-of-pocket cap per month on medication for all patients. Co-insurance health plans, which require a patient to pay a percentage of the cost for treatment, would also be banned.
The health insurance industry opposes the measure, saying the overall cost of prescription drugs rose by nearly 7 percent last year alone, and these specialty drugs are extremely expensive. If patients don't pay more, nearly $220 million in losses would be passed on to other premium holders.
"The cost of a thing is the amount of what I call life which is required to be exchanged for it, immediately or in the long run."
-- Henry David Thoreau
Karen Midthun, FDA's presiding officer for the June 28-29 hearing, has indefinitely postponed the submission deadline for written summaries of the parties' arguments.
The summaries had been due on May 5. However, in a May 2 letter to counsel for Genentech and CDER, Midthun said the submissions will instead be due one week after the formal hearing notice is posted for public review in the Federal Register.
Midthun concedes that the formal notice "will be issued somewhat later than we had intended," but that delaying submission of the parties' written arguments "will give you a better opportunity to address the issues as framed in the notice."
When the notice will be published remains in question. "We do not, at this point, know the exact date on which the notice will be posted," Midthun tells the parties. "A copy will, however, be sent to you on that date."
And speaking of Avastin, a new 1200 patient NIH trial has confirmed that it’s “just as effective” as Lucentis. The related news is that a new model for Medicare payments (ACOs, scheduled to launch in January 2012) may offer another way to address the cost differential.
(Note: The study found no major differences in major adverse events between patients taking the two treatments. However, patients prescribed Avastin were slightly more likely to experience non-specific serious adverse events, primarily hospitalizations, than those given Lucentis (24.1% versus 19%. Add to that a Genentech-sponsored study, suggesting an 11% higher risk in mortality and 57% higher risk of hemorrhagic cerebrovascular accident in patients treated with Avastin versus Lucentis and “just as effective” is put in a better perspective.)
CMS released a proposed rule in late March laying out a framework for the first phase of an ACO program, which is being established under the Affordable Care Act. (An ACO is an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries in their care and in the traditional fee-for-service program.
-- Flip Wilson
How did David Geier – who along with his father Mark Geier – conducted fraudulent research on how vaccines caused autism and enriched themselves by selling an autism “cure”, get appointed to the state of Maryland’s autism commission?
David Geier and Mark Geier are the state of Maryland’s answer to Andrew Wakefield. Like Wakefield, the Geiers have had their credentials as scientists shredded and have had paper retracted because of their bogus claims that vaccines and mercury preservative cause autism. Like Wakefield, the Geiers have made a bundle peddling snake oil diagnostics and dangerous treatments to kids with autism. In the Geier’s case it was injecting autistic children with Lupron, a drug used to perform chemical castration on sex offenders and reduce hormone levels to treat prostate cancer.
In my book Tabloid Medicine I noted that the Geiers deliberately manipulated data about vaccine safety to show a link between more shots and more autism and then went on to sell themselves as expert witnesses in vaccine liability cases and as the inventors of a new battery of tests and treatments for diagnosing and treating autism. I build on the work of others, including Kathleen Seidel who, as put together a blockbuster 16-part series on her website, neurodiversity.com. Similarly, in 2009, the Chicago Tribune ran a series that shone attention on the Geiers’ work, including “Miracle drug called junk science“ by Trine Tsouderos, “Autism treatments: Risky alternative therapies have little basis in science,” by Tsouderos and Patricia Callahan.
The Geiers's sordid history was already in plain sight before Wakefield was finally exposed as a fraud as well as a fear monger by Brian Deer in his three part investigative series Secrets of the MMR scare.
So when David Geier submitted his application to be named to the Maryland Commission on Autism how was it that no one raised a question or objected until Mark Geier’s medical license was suspended the state’s Board of Physicians?
Or more to the point: How did David Geier get the nod in the first place? As a “diagnostician” no less?
As the Baltimore Sun’s Meredith Cohn dryly observed: “It's not clear what specific element of his application won the seat on the panel, on which 60 people requested positions. Neither he nor his father has made political contributions, according to state data. And court records show that at one time, the family business owed more than $500 in back taxes to the state, which it was ordered to pay.”
http://www.baltimoresun.com/health/bs-hs-doctor-suspension-20110505,0,7283787.story
Here’s a clue: The Geiers did have their association with John L. Young, MD.
Who is Dr. Young and why might he be connected to David Geier’s appointment?
In 2009, Dr. Young “was the President of the Montgomery County Medical Society, the largest component medical society in Maryland. From 2007 to 2009, he was asked by Maryland Governor Martin O'Malley to serve as a Commissioner for the Maryland Community Health Resources Commission, and in 2009, was appointed by Governor O'Malley to serve on the Board of Regents for the University System of Maryland.”
That information is taken from the website of ASD Centers, which the Geiers set up to peddle Lupron and other dangerous and disproven autism treatments. That’s because John L. Young, MD -- founded in 2008 -- along with Mark Geier -- ASD Centers.
http://www.autismtreatmentclinics.com/Staff.html
And there’s more: The Geiers set up an Institutional Review Board (IRBs are established to review the impact of clinical research on human subjects) to approve their own research, conducted by ASD Centers of course. The IRB called the Institute for Chronic Illnesses turned out to be Mark Geier’s home.
More problematic, John Young was a ‘co-investigator’ with Mark and David Geier in their Lupron research.
Even worse, Young was also a member of the IRB.
http://www.neurodiversity.com/weblog/article/98/
There’s more: “Dr. Young is Dr. Geier’s business partner in Genetic Consultants of Maryland and Genetic Consultants of Virginia; he, Dr. Geier and various business entities were codefendants in a 1994 medical malpractice lawsuit. He is also a newly-minted DAN! practitioner. According to his ARI listing, Dr. Young completed an eight hour training at the May 24-28 2006 DAN! conference in Washington, DC. Treatments he offers include antifungal pharmaceuticals and nutriceuticals, chelation, antiviral medications, and Lupron injections.)”
If I were the media, the state’s Board of Physicians or Governor O’Malley I might want to have a conversation with Dr. Young. I would ask him if he was involved with appointing David Geier. It might be interesting to find out what role he might have had in not bringing to light the Geiers’ past abuses to the Governor and the Board of Physicians.
I’ve just returned from deep in the heart of America’s Medicine Chest (Princeton, NJ), where I was proud to chair the Social Media for Pharma conference. The conversation included when FDA guidelines might be released (and if it even matters), the appropriate balance between sales and education, the role of the digitally empowered healthcare consumer, the clash between marketing and medical/legal review and, of course, who’s doing what – and how can it be measured?
A few selected comments from the esteemed faculty (attributed where appropriate, unnamed otherwise):
Wendy Blackburn (InTouch Solutions) – “True two-way dialogue between pharma companies and patients is like sex in high school. It’s risky. Everyone is talking about it. Everyone thinks they want to do it. No one is really sure if anyone is doing it or not. It’s definitely happening.”
Pat Connelly (Millennium Pharmaceuticals) – “I have tried and failed with more social media ideas than anyone I know.” Good for you Pat. Remember what Thomas Edison said when asked why he was so successful: “Because I fail faster than anyone else.”
Tony Jewell (AstraZeneca) – “If I had known that our live tweet-up was an industry first, we probably wouldn’t have done it.” (That got a laugh – but I don’t think it’s true.)
Mark Karch (Appature) – “Data is the new black.” (That may be so – but does it make me look fat?)
Marc Monceau (J&J) on dealing with the “Motrin Mom’s” issue (which broke online after 5pm on a Friday) – “We had to be nimble and quick.” (Which is a good idea if you want to avoid the heat of the candle stick.)
Joseph Kim (Shire Pharmaceuticals) -- "Inside pharma, social media musn't be a battle between cheerless eggheads and happy morons."
Ron Petrovich (Mayo Clinic) – “We do not offer tiger blood transfusions – yet.”
Anonymous -- “When it comes to social media, if you stick your head in the sand, you’re going to get kicked in the ass.”
Anonymous – “The rules of healthcare social media are like your dog’s invisible fence – you’re not sure where the perimeter is – but it’s shocking when you find out.
Anonymous – “Whenever somebody says they’re being transparent, I suspect they’re hiding something.”
And to quote myself – “Social media is communications at the speed of life. As Marshall McLuhan wrote, At electric speed, all forms are pushed to the limits of their potential. (Replace “electric” with “digital” and it’s amazing how prescient McLuhan was. That’s genius.) That’s a wonderful challenge, to be pushed to the limits of our potential. If you are not ready to do so, it’s time to look for another job.
Onwards and Excelsior.
From the Pink Sheet:
Data Exclusivity Remains A Top Issue In USTR's 2011 Special 301 Report
The failure of U.S. trading partners to adequately protect pharmaceutical test data remains one of the top concerns of the United States Trade Representative in its 2011 Special 301 Report on intellectual property rights.
The report encourages several countries to protect against unfair commercial use and unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval of pharmaceutical products. The countries cited include Algeria, Argentina, Chile, India, Indonesia, Pakistan, Brazil, Dominican Republic, Ecuador, Egypt, Malaysia, Mexico, Turkey and Paraguay.
In its annual Special 301 report, the USTR places U.S. trading partners deemed to provide insufficient IP rights protection, enforcement or market access on a Priority Watch List, Watch List or Section 306 monitoring list. Of 77 trading partners reviewed, the USTR put 12 countries on the Priority Watch List, 29 on the Watch List, and one, Paraguay, on the monitoring list. China, India, Israel, Thailand and Venezuela are among those on the Priority Watch List.
The report, released on May 2, includes an extensive discussion of China. It notes that pharmaceutical manufacturers have reported positive results from China's "Program for Special Campaign on Combating IPR Infringement and Manufacture and Sales of Counterfeiting and Shoddy Commodities," which was launched in October 2010.
"According to rights holders in this sector, law enforcement has been reaching out to individual companies, investigating leads early on, and bringing criminal prosecutions against infringers," the report states. "Rights holders detect more diligence and promptness on the part of Chinese authorities in developing criminal counterfeit pharmaceutical cases."
However, the report says the United States is troubled by China's May 2010 prosecution guidelines that tripled the threshold for investigating and prosecuting trade in counterfeit goods.
Christopher Singer, Pharmaceutical Research and Manufacturers of America President, International, said in a statement on the report that China "continues to circumvent data protection obligations and permit widespread distribution of unregistered active pharmaceutical ingredients."
Singer also said India has had significant delays in providing data protection and expressed concern about the scope of patents and coverage of incremental innovation, delays in providing patents and recent court actions to limit or undermine patentablility. He also expressed support for USTR's out-of-cycle review of Thailand, saying the country's "weak protection" of IP rights is especially troubling.
While Japan, Poland and New Zealand did not make either watch list, the USTR singled them out in the report, citing the pharmaceutical industry's concerns about their policies.
U.S. industry has "expressed serious concerns about the policies and operation of New Zealand's Pharmaceutical Management Agency," including the transparency, fairness and predictability of its pricing and reimbursement regime, the report states.
The report says industry also is concerned about health care reform legislation introduced in Poland in 2010 that would alter the country's pricing, reimbursement and clinical trials policies. The report also notes that the pharmaceutical industry is upset that it has not been able to meet with Poland's Ministry of Health to discuss these initiatives.
As for Japan, USTR says it is seeking further improvements in transparency and reform of reimbursement and regulatory systems that "would facilitate the timely introduction of innovative pharmaceuticals and medical devices into Japan's market."
The 2011 report is similar to last year's. In addition to data exclusivity, the USTR also reiterates its concerns about patent laws in India and the Philippines that prohibit patents on certain chemical forms unless they show increased efficacy.
Despite making major concessions to the United States, Israel remains on the Priority Watch List. Last year, it reached an understanding with the U.S. to strengthen laws on protection of pharmaceutical test data and patent term extension and to publish patent applications 18 months after the application is filed. While Israel has submitted legislation for the protection of pharmaceutical test data, the report says it has not submitted legislation regarding patent term extension or patent publication.
Compulsory licensing, once a major issue for USTR, is mentioned only with respect to China and Ecuador. China's draft regulations for patenting technologies used in national standards may allow a compulsory license if a patent holder does not grant a royalty-free license. As for Ecuador, the report says simply that the U.S. "will continue to monitor developments concerning compulsory licensing of pharmaceutical and agricultural chemical products."
Jamie Love, director of Knowledge Ecology International, an organization that closely tracks IP and trade policy, said the report does not convey the arm twisting that goes on behind the scenes.
"The USTR discussion of IPR policy concerns seems muted in the report, compared to the pressure that the U.S. government actually applies both behind the scenes and in different trade fora," Love said in a blog posting. "In practice, the 301 Report represents only a fraction of the issues being raised and the pressures being applied by the White House and various federal agencies."
Industry also is concerned about the inclusions of IP rights in a regional trade agreement currently in development, the Trans-Pacific Partnership (TPP) Agreement. The United States and its TPP partners - Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam - held their sixth round of negotiations in Singapore last month and are to hold the seventh round the week of June 20 in Vietnam. The U.S. expects the agreement to increase American exports to the Asia-Pacific.
PhRMA is advocating for a strong IP chapter. In an April 2011 document, "PhRMA Views: Intellectual Property (IP) Chapter for the Trans-Pacific Partnership (TPP) Agreement," the association said data protection is essential to recoup R&D expenses. It cites the provision in the U.S. health care reform law that provides 12 years of data exclusivity - the time during which a generic or other competitor cannot use clinical data generated by an innovator to obtain marketing approval - for biologics.
PhRMA also says countries should be required to provide patent term adjustments to compensate for the loss of effective patent term from delays in marketing approval and the issuance of a patent. And it says the TPP "must include a mechanism to permit a patent owner to resolve patent infringement issues prior to marketing approval of the infringing pharmaceutical product."
From the pages of the New York Times:
Doctors' Prescription Records
To the Editor:
A recent Business Day article reported that the Supreme Court will review a Vermont law that limits the sale of doctors’ prescription records (“A Fight Over How Drugs Are Pitched,” April 25). The high court should invalidate the law. Not only is it redundant, it also undermines federal efforts to promote drug safety.
The American Medical Association already runs a national program that allows doctors to opt out of having their data available for sale. There is no need for states to duplicate its efforts.
Further, pharmaceutical companies rely on physicians’ prescription records to disseminate F.D.A.-directed safety warnings. Without access to doctors’ prescription data, they don’t know how many patients are taking specific drugs, or for how long. Such data are crucial to addressing safety issues quickly.
PETER PITTS
New York, April 25, 2011
The writer is president of the Center for Medicine in the Public Interest and a former F.D.A. associate commissioner.
www.chicagotribune.com/health/ct-health-chat-pseudoscience,0,4487863.htmlstory
Avoiding Internet pseudoscience
Join us at noon CT (1 p.m. ET/10 a.m. PT) on Tuesday, April 19, for an hour-long chat about filtering through pseudoscience on the Internet, with the Tribune's health reporter Trine Tsouderos and panelist Robert Goldberg.The Internet has become a major source of medical information for millions of us as we wonder what might be causing our headache, what to do about our child's hyperactivity, whether we should be worried about that mole or not, whether homebirth is safer than hospital birth. We Google cures for cancer, silver bullet weight loss strategies, treatments for autism and risks associated with vaccines.
Are we better informed? Or are we bathing in a tub of bad information and even undermining our own health? Join journalists Trine Tsouderos and Robert Goldberg for an hour-long discussion of the Internet as a source of medical information and misinformation. We'll be discussing how to avoid slipping in puddles of pseudoscience and instead, how to become an astute consumer of online medical information. In a national PEW Study, find out what type of health advice people ages 18 and up are most likely to look for online and who is most likely to look for health advice online.
Journalist Robert Goldberg is the author of "Tabloid Medicine: How the Internet Is Being Used to Hijack Medical Science for Fear and Profit." Co-host of the blog www.drugwonks.com, Goldberg's work has appeared in the Wall Street Journal and Los Angeles Times. He is also vice president of the non-profit Center for Medicine in the Public Interest.If you would like to submit a question in advance, please e-mail Trine Tsouderos at ttsouderos@tribune.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.
