Less is Ma

05/09/2011 08:54 AM |

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.

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A Learning Curve Ball

05/09/2011 08:34 AM |

"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

Firsts can be tough. Avastin marks the first time the FDA has convened a hearing to withdraw an indication under its accelerated approval regulations – and there are unique administrative and procedural difficulties contributing to the agency's delay in releasing the formal FR notice.

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.

“The cost of living is going up and the chance of living is going down.”

-- Flip Wilson  Read More & Comment...

How Did Autism Quack Get On Maryland Autism Panel?

05/06/2011 05:55 PM |

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 Seth Mnookin notes, “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. 

 

 

 

 

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In This Game, Patients and Doctors Lose

05/06/2011 02:52 AM |

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Was it good for you?

05/05/2011 08:58 AM |

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.

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IP Daily

05/05/2011 07:55 AM |

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."

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Waiting on the Supremes

05/04/2011 04:27 PM |

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.

 

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Pseudoscience on the Web

05/04/2011 02:11 PM |

My PREVIOUS online chat with Chicago Trib health reporter Trine Tsouderos.. I encourage everyone to follow her on Twitter @Trine_Tsouderos

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.

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Adding Reps to the Routine

05/03/2011 01:37 AM |

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Katy debar the door

05/02/2011 09:22 PM |

From the editorial page of the Wall Street Journal ...

Kathleen Spitzer

The Administration targets a drug CEO in a troubling precedent.

Health and Human Services Secretary Kathleen Sebelius made her political name in Kansas, though we wonder if she's getting special advice from Eliot Spitzer. Her department's latest attack, on the CEO of Forest Laboratories, is straight out of the former New York Attorney General's bullying playbook.

HHS this month sent a letter to 83-year-old Forest Labs CEO Howard Solomon, announcing it would henceforth refuse to do business with him. What earned Mr. Solomon the blackball? Well, nothing that he did—as admitted even by HHS.

Forest Labs entered into a federal plea agreement in September over misconduct in its marketing of antidepressants Celexa and Lexapro. The allegations were among a rash of government suits claiming that marketing to doctors common among drug companies amounted to fraud against Medicare and Medicaid. The charges were odd given their implication that major companies would be dumb enough to try to hoodwink their biggest customer.

 

The charges also had a political flavor as an attempt to blame drug companies, rather than the fee-for-service design of the federal programs, for runaway costs. But some companies including Forest chose to settle rather than engage in extensive litigation.

 

In any case, the federal complaint contained no suggestion that Mr. Solomon was involved with, or even aware of, misconduct. And the question of his continued leadership was never part of the plea deal.

 

Only after a federal court ratified the deal in March did HHS drop its intent-to-ban bomb. Mrs. Sebelius unearthed a dusty provision in the Social Security Act that allows officials to bar executives of health companies from doing business with the government when the firms are guilty of criminal misconduct.

 

The feds have rarely invoked this awesome power, given the potential for coercive abuse. But Mrs. Sebelius seems bent on making it more common policy and says she can employ it even against executives who had no knowledge of an employee's misconduct. A year ago Mrs. Sebelius used it to dismiss the CEO of a small drugmaker in St. Louis.

 

This is a threat to every health CEO in America. If Forest wants to continue to sell its drugs to Medicare, Medicaid and the Veterans Administration—the biggest buyers of pharmaceuticals—it will have to change management. Losing the federal government as a customer is potentially crippling to a drug company.

HHS says its action is about holding corporate CEOs accountable, but it looks more like the Administration's latest bid to intimidate the health-care industry into doing its bidding on prices, regulations and political support for ObamaCare. This is the same agency that has threatened insurers with exclusion from new state-run health exchanges if they raise their premiums more than Mrs. Sebelius wants, or if they spread what she deems to be "misinformation" about the President's health bill.

 

The hammer on Forest Labs "reinforces everybody's worst fears—that this Administration won't do business with anybody that doesn't completely agree with its policy initiatives. Not only will it refuse to even have the argument, it will actively destroy these people," says Peter Pitts, a former Food and Drug Administration official who now runs the Center for Medicine in the Public Interest.

 

The precedent here is also a recipe for much more litigation. Regulators aren't above bringing flimsy cases, and corporations often settle them simply to avoid huge legal bills and additional public relations risk. If the Obama Administration intends to view every such settlement as an admission of guilt and then dictate who can run the company, you can expect a lot more litigation.

 

Forest Labs is sticking by Mr. Solomon, saying the exclusion is "unjustified." But even the company has acknowledged that if Mrs. Sebelius implements her ban, Mr. Solomon would be forced to step down at least temporarily while the company takes her to court. Every CEO in America will get the message that his job is at risk if he quarrels with an Administration's bureaucratic orders.

 

This reminds us of a similar exercise by the Justice Department against former General Re CEO Joseph Brandon. Mr. Brandon cooperated in an investigation into a 2000 reinsurance transaction between Gen Re and AIG. But the feds leaned on Warren Buffett, the chairman of Gen Re parent Berkshire Hathaway, to fire him. Mr. Buffett praised Mr. Brandon but still sacked him in 2008, though later the feds closed the case with no action against Mr. Brandon.

 

CEOs are accountable for their actions, but it is simply unjust for a powerful regulator like Mrs. Sebelius to threaten a company with ruin if it doesn't dismiss a CEO who has had no formal charges or proof of wrongdoing brought against him. It's another example of how this Administration views private companies as little more than agents of greed that must be made examples of when the political need arrives.

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Let's Get Technical

05/02/2011 09:39 AM |

From the Pink Sheet:

PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers

Industry and FDA agreed to a recommendation package for the PDUFA V commitment letter after dividing agency proposals into three tiers and funding two. Industry had considered 11 changes proposed by FDA for inclusion in the reauthorization of the Prescription Drug User Fee Act. Ultimately, three proposals were not funded because industry did not see them as pressing needs. However, firms did agree to FDA’s higher projections for the additional employees and other costs that would be required to fund the other programs. FDA would not confirm an agreement had been reached. The agency expects to publish the proposals, likely in late summer or early fall, after their clearance by the full administration. As of March 31, the agency and industry appeared to have reached an agreement on a package of recommendations for the PDUFA V commitment letter. Minutes of that meeting, released April 28, indicated final reviews and minor clarifying edits were made to the package (“PDUFA V Agreement Appears Set Between FDA And Industry,” “The Pink Sheet” DAILY, April 28, 2011). Trial Design, Inspections Left Unfunded Proposals to expand the Quality-by-Design program, enhance agency capacity to review and develop non-inferiority and adaptive trial designs, and conduct more real-time clinical trial site inspections were not funded. Industry said based on input from its members, “the needs in the areas of non-inferiority and adaptive trial designs and Quality-by-Design are not as great” as some other areas, according to minutes of a Feb. 10 negotiating session. Industry also said clinical trial oversight was a job sponsors take seriously and member companies felt they were currently meeting appropriate standards, according to the minutes. The cut likely was an effort to limit the increase in user fees necessary to handle the additional staff that would be required for the new programs. Industry already had spent part of the negotiations attempting to change inflation and other user fee revenue adjustment formulas so they would more accurately reflect current economic conditions (“PDUFA Formula Could Better Incorporate Present Economic Conditions,” “The Pink Sheet,” April 18, 2011). The move meant eight proposals, in addition to changes to the application review system, were included in the commitment letter that both sides were reviewing for the final time during the March 31 session. Adding patient and advocate views to risk-benefit decision-making, increasing staff for rare disease and biomarker development, creating a dedicated meta-analysis team, and standardizing Risk Evaluation and Mitigation Strategies for better integration into the health care system were among those in the agreement (see chart, "PDUFA Proposal Sheds Tier 3 Funding"). FDA agreed to limit the commitments to the top two tiers of proposals, but would not agree to the 100 additional full-time equivalents industry proposed to staff the programs. That estimate did not include additional personnel required for changes to the application review system. The agency said it required full resourcing of the proposals, including “drug safety staff critical to REMS and other safety-related work.” At a Feb. 15 meeting, FDA said it would need 119 FTEs and an additional $4.17 million per year in “other direct costs,” according to minutes of the session. By March 10, when reviews of the draft commitment letter had begun, industry had agreed to FDA’s request, according to minutes of that session. Industry asked the agency to give annual reports on the progress of the initiatives, including hiring and staff placements. FDA agreed to post annual reports on its website, according to the minutes. New Review Model Alters Submisson Timeline The application review system changes mostly followed the model that had evolved through the PDUFA process, but the sides could not agree on a system for allowing inexperienced drug sponsors to ask FDA clarifying questions related to their applications. Both sides debated adjustments to the review system throughout the negotiation process, which began in July 2010. Industry wanted to include more communication between sponsors and FDA during the review, while FDA wanted to improve its record of first-cycle approvals. The two sides decided on a new system that will be used for new molecular entity new drug applications and novel biologics license applications that would result in a de facto two-month extension of review times, and more formal opportunities for sponsor interaction with the agency. The program had been scheduled to start as a pilot, but both sides decided it would apply throughout the user fee cycle. Pre-submission meetings will be required at least two months before the application is filed, where the agency and sponsor will talk about what components must be submitted and which can be sent within 30 days after the original filing. An applicant that does not have a pre-submission meeting would essentially not be allowed to amend the application after it was submitted, according to the minutes. It is a nod to FDA’s efforts over the past several months to remind sponsors that applications must be as complete as possible at submission so agency staff can better plan the review (“PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement,” “The Pink Sheet,” March 28, 2011). For sponsors that do have a pre-submission meeting, unsolicited amendments will be handled using current guidance. Both sides also agreed to definitions of whether a modification to a REMS submission constitutes a major amendment, including instances where REMS changes would not be considered a major amendment. Major amendments would warrant a three-month timeline extension, although there was no mention in minutes of the Feb. 10 meeting, during which the proposal was agreed to, whether the new system would require the extension no matter when the amendment was received. The review clock will not start until after a 60-day filing period, and sponsors will be able to talk with agency officials at mid- and late-cycle meetings to discuss application problems. Late-cycle Meeting Might Lack Division Letters Industry proposed another change to the system during a March 25 session that would have required FDA to send all primary and secondary discipline review letters to sponsors eight to 12 days prior to the late-cycle meeting to ensure substantive discussions would be possible. The letters are used to communicate application problems found by different review teams looking at an application. FDA refused, but said if discipline review letters were not ready before the late-cycle meeting, the pre-meeting memoranda would include the problems identified. Applications in the program will be tracked to note review team performance. An interim assessment also will be conducted to determine whether the program should continue through fiscal years 2016 and 2017, the final two years of PDUFA V. If it is scrapped, applications received during that time would be governed by rules that apply to all other applications, according to the minutes. Industry has pushed throughout the process for assessments of new programs as well as the ability to change them during the PDUFA cycle if they are not effective (“PDUFA Needs Mid-Cycle Correction System As Part Of Reauthorization, Industry Says,” “The Pink Sheet,” April 18, 2011). By Derrick Gingery

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And please limit your response to no more than 8 million words

05/02/2011 07:44 AM |

BioCentury reports that, per meeting minutes released by the FDA on Thursday and Friday, the agency and industry have an agreement for PDUFA V. On the financial front, "Industry agreed to include the $65 million in additional fee revenues for drug safety in FY 2012 in the base fee revenue amount for PDUFA V.”

 

Next step is for the FDA to hand its draft PDUFA V recommendations to the White House for review. Then, if all goes according to plan, the agency hopes to transmit its final PDUFA V recommendations to Congress on Jan. 15, 2012.

 

And yet, curiously, CDER Deputy Director Doug Throckmorton (PS/one of the smartest and hardest working guys at the agency) announced that the FDA will hold a PDUFA Public Meeting in September to get more input. 

 

Hm.

 

On a separate but related note, the FDA has begun a review of its regulatory operations to determine if they can be made more effective. The agency is requesting comments on whether existing rules are "outmoded, ineffective, insufficient, or excessively burdensome."

Ya think?

The review is being conducted in response to an executive order issued by President Obama in January and the deadline for comments is June 27.

So stop griping and start typing.

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With friends like these...

04/28/2011 08:40 PM |

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When the government talks to your doctor, who’s listening?

04/28/2011 08:00 PM |

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FDA Ignoring Public Health Danger of Anti-Vax Ads

04/28/2011 03:08 PM |

 

 

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Love's Labors, Alas, Not Lost

04/27/2011 09:06 AM |

Jamie and the Love-ites are on a quest to co-opt the debate over the growing problem of non-communicable diseases in the developing world to further their own anti-IP agenda.

 

Consider this new article from Intellectual Property Watch (Note – all bolded portions have been so noted by me):

Non-communicable diseases such as cancer and diabetes now have a global reach, and are the leading cause of death, according to the World Health Organization, which describes them as an “epidemic.” Once considered problems of rich countries, they now hit low- and middle-income populations the worst, says WHO, but preventive actions could be taken. Meanwhile, civil society is warning about the lack of availability of medications to treat non-communicable diseases in developing countries.

 

In the battle of rhetoric, the anti-IP community has co-opted the term “civil society” for themselves.  Don’t be fooled by the Mahatma-sounding moniker.

 

In an effort to address this, WHO will launch its Global Status Report on Non-Communicable Diseases (NCDs) tomorrow, at its first global forum on the subject, being held in Moscow on 27 April.

 

The global forum brings together stakeholders to “share views and experiences to date on the challenges and opportunities” in NCDs, in particular for their prevention, treatment and control.

 

One of the objectives of the forum is to understand expectations, roles and contributions of different stakeholders in support of the September 2011 United Nations High-Level Meeting on NCDs. Another objective is to mobilise a “broader base of stakeholders in support of NCD prevention and control, in particular in developing countries,” WHO said.

 

And “stakeholders,” in case you were wondering, does not mean the pharmaceutical industry.

 

Following the global forum, the WHO is holding a first Global Ministerial Conference on Healthy Lifestyles and Noncommunicable Disease Control, co-organised with the Russian Ministry of Health, according to a WHO press release.

 

The conference seeks to assist an ongoing international campaign to “curb the impacts of cancers, cardiovascular disease, diabetes and chronic lung diseases,” and support member states’ efforts to develop policies and programmes on healthy lifestyles and NCD prevention.

Can you say, “compulsory licensing?”

 

The goal of the conference is to highlight the scale of NCDs and their socio-economic impact, to review international experience on prevention and control, and to provide evidence on needs to boost prevention “as part of national health plans and sustainable development frameworks.”

 

Can you say “Thailand?”  Can you say “Brazil?”

 

A group of six nongovernmental organisations submitted recommendations to WHO member states prior to the meeting. They are calling for “affordable, appropriate, and good quality medicines, vaccines and diagnostics to persons suffering from NCDs in low- and middle-income countries,” according to the recommendations.

 

And yes – it’s the usual suspects.

 

Knowledge Ecology International, Médecins Sans Frontières, Oxfam, Third World Network, Universities Allied for Essential Medicines, and Young Professionals Chronic Disease Network described a shortage of NCD medications in developing countries, even for medicines that are off-patent. Generic medicines production is threatened, they said, as developed countries are seeking to include data exclusivity in free trade agreements with developing countries.

 

See – they buried the lead.

 

In particular, they recommended safeguarding generic production as the most effective way to lower prices, and for member states to use flexibilities enshrined in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

 

Sound familiar?

 

The groups also advised incentivising research and innovation, and called on countries to: adopt strategies which de-link the cost of medicines from the cost of research and development, and apply the concept of prizes as an incentive for innovation in cancer treatment. They also called for the provision of funding to study the feasibility of cancer prize funds in both developed and developing countries. And the NGOs asked for quality assurance so that medicinal products meet WHO quality standards.

 

Ah yes, the famous “prize” idea. The same idea that has failed everywhere it has been tried – most famously in Soviet Russia.  For more on this idiocy, see here.

The complete IP Watch article can be found here.

 

Danger Will Robinson.  Danger.

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Run Forest, run!

04/26/2011 01:42 PM |

Forest is sticking by its chief. "No one has ever alleged that Mr. Solomon did anything wrong, and excluding him [from the industry] is unjustified," said general counsel Herschel Weinstein. "It would also set an extremely troubling precedent that would create uncertainty throughout the industry and discourage regulatory settlements."

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@lougehrig

04/26/2011 08:29 AM |

From the Wall Street Journal -- many important lessons to be learned -- as well as one really cool name: Merit Cudkowicz.

ALS Study Shows Social Media's Value as Research Tool

 By AMY DOCKSER MARCUS

A new clinical trial found that lithium didn't slow the progression of Lou Gehrig's disease, but the findings released Sunday also showed that the use of a social network to enroll patients and report and collect data may deliver dividends for future studies.

The study was based on data contributed by 596 patients with the disease, formally called amyotrophic lateral sclerosis or ALS. By showing that the drug didn't have any effect on progression of the condition, it contradicted a small study three years ago that suggested such a benefit was possible.

The new study, published online in the journal Nature Biotechnology, represents an early example of how social networking could play a role in clinical trials, an area of medical science with strict procedures that many would consider especially difficult to apply in the online world.

"The approach has tremendous potential,'' said Lee Hartwell, a Nobel Prize-winning scientist now at Arizona State University, and formerly president of the Fred Hutchinson Cancer Research Center. Standard clinical trials play a central role in the research enterprise of both of those institutions.

Dr. Hartwell, who wasn't involved in the study, said social-network trials aren't likely to replace conventional randomized, double-blinded, placebo-controlled trials, the gold-standard for generating medical evidence. But such trials have become so complicated and time-consuming that new models are needed, he said.

 Paul Wicks, a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.

In many diseases, "sometimes the alternative is not our way or the old way. It is our way or it is not studied at all,'' said Dr. Wicks, the research and development director at PatientsLikeMe, a closely held health-data sharing company in Cambridge, Mass., that ran the lithium study.

More than 4,300 patients are on the PatientsLikeMe ALS site, where they frequently share information on how their disease is progressing and strategies they are using to fight it.

Jamie Heywood, chairman and co-founder of PatientsLikeMe, said the idea for the new study came from patients. After the 2008 paper reporting lithium slowed down the disease in 16 ALS patients, some members of the site suggested posting their experiences with the drug in an online spreadsheet to figure out if it was working. PatientsLikeMe offered instead to run a more rigorous observational study with members of the network to increase chances of getting a valid result.

The company developed a tool to standardize collection of patient data, including lithium blood levels in patients. They used a questionnaire from conventional ALS trials to gather patients' self-reported data on functions such as swallowing, walking, and breathing.

In conventional studies, patients are randomly assigned to a treatment or control group to reduce sources of bias. Neither doctors nor patients know who is getting the drug.

In the on-line study, patients decided themselves if they wanted to take lithium. They needed to persuade a doctor to write a prescription. They were also able to see on the website how others taking the drug were faring in real-time. All of this raised chances that the study could lead to a false conclusion.

To address the concern, PatientsLikeMe developed an algorithm that matched 149 patients taking lithium with at least one other ALS patient on the site who didn't take the drug. A total of 447 patients were among this group that researchers considered controls.

The study didn't find any difference in disease progression a year after treatment between those taking lithium and the control group, researchers said.

Mr. Heywood said the result was apparent nine months after the study was launched. Conventional trials typically take more time just to enroll patients, he noted. Costs for drugs and recruiting patients were avoided.

Merit Cudkowicz, an ALS researcher at Harvard Medical School who was an investigator on a standard lithium clinical trial, said social network-generated data can offer valuable insights, but she cautioned that the PatientsLikeMe study was not a substitute for more rigorous studies. Two conventional on-going ALS studies are designed to see if lithium has a very small effect on survival, something the PatientsLikeMe study wouldn't be able to pick up.

"The thing you don't want to do in a fatal illness is to throw out potentially good drugs that might have small but meaningful effects,'' she said.

 

Source: PatientsLikeMe, WSJ research

Write to Amy Dockser Marcus at amy.marcus@wsj.com

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Punishing work

04/25/2011 02:18 PM |

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"Bad Ad" Fad Unclad

04/22/2011 08:16 AM |

In the immortal words of Theodore Roosevelt, “When you are in a hole, stop digging.”

I refer, of course, to the FDA’s embarrassing “Bad Ad” program.  After the initial rollout last year in which 33,000 health-care providers were informed about the program, an aggressive agency media effort, brochures, and medical meeting outreach the initiative has resulted in some skin in the game … one letter … for “Derma Smoothe Body Oil.” 

At best this effort isn’t, um, cost effective.

At worst, it’s compliance through secret commination. Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber?  Really?  Whatever became of transparency.  What’s next? Anonymous adverse event reporting?

The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law.  In the Old West this was more generally referred to as a posse, or worse – a lynch mob.

Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy. A smart move by the FDA would have been to allow the program to quietly wither away.

Instead, the agency is going on the offensive – making a bad idea even worse by holding it up for broader public scrutiny that will, undoubtedly further embarrass the agency and attract Congressional scrutiny.

Witness this media alert (I am not making this up):

FDA CONSUMER HEALTH INFORMATION – April 28 Webinar: Bad Ads Program

The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on advertising to consumers.

Responsible promotional efforts can give health care professionals valuable information about the latest drug treatments. But not all promotions are accurate and balanced.

Through its Bad Ads Program, the Food and Drug Administration (FDA) asks health care professionals for help in making sure the promotion of prescription drugs is not false or misleading.

Learn how the Bad Ads Program helps protect the public during a 30-minute webinar.

An opportunity to ask questions will follow the presentation.

When:   Thursday, April 28, 12:00 p.m. (ET)

Length: 30 minutes

Where:  To join the webinar, see the instructions at

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm249817.htm

Host: Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research

Featured speaker: Catherine Gray, Pharm.D., of the Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research.

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

If you want a more detailed discussion of the “Bad Ad” program’s failure, have a look at the article, “FDA's 'Bad Ad' Program Generates One Warning Letter in First Year” in the current edition of Advertising Age.

Here’s how the article begins, “Nearly a year into the Food and Drug Administration's "Bad Ad" program, only one pharmaceutical company has received a warning letter that stemmed from the initiative and the recipient called it a "joke."

The complete article can be found here.
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