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.

  Read More & Comment...

Adding Reps to the Routine

05/03/2011 01:37 AM |

  Read More & Comment...

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.

  Read More & Comment...

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

  Read More & Comment...

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.

  Read More & Comment...

With friends like these...

04/28/2011 08:40 PM |

  Read More & Comment...

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

04/28/2011 08:00 PM |

  Read More & Comment...

FDA Ignoring Public Health Danger of Anti-Vax Ads

04/28/2011 03:08 PM |

 

 

  Read More & Comment...

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.

  Read More & Comment...

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."

  Read More & Comment...

@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

  Read More & Comment...

Punishing work

04/25/2011 02:18 PM |

  Read More & Comment...

"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.
  Read More & Comment...

Action is Eloquence

04/21/2011 11:33 AM |

As the weather turns warmer and you’re looking for some beach reading, may I recommend FDA’s, “Strategic Priorities 2011-2015:  Responding to the Public Health Challenges of the 21^st Century.”

And therein the first issue.  If the FDA views it’s job as only responding to challenges, that needs to change.  The FDA needs to be a change agent – to drive change.

As the bard said, “Action is eloquence.”

The good news is that, under “Vision,” the report reads as follows:

FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.

Leadership.  Crucial.  Both domestic and international.  Absolutely.

There are many crucial initiatives (and I am pleased to report that advancing regulatory science is given a lot of ink).  But since we are dealing with the future here, the report is lacking in, what we might call, PDUFAbulousness.

Here’s what the report says about “accountability” --

Consistent with our strong commitment to public service, we will maintain the highest degree of individual and professional accountability in the quality and ethical conduct of our work. Currently, we set measurable goals and openly monitor performance within the agency to make sure we continue to meet our commitments. We hold staff members and executives accountable for achieving organizational goals through annual performance plans that are aligned with our strategic priorities. And we monitor program performance by holding quarterly meetings with program managers and agency executives and sharing program performance data with the public through a new initiative called FDA-TRACK.  We understand the importance of FDA's work to the health and welfare of our nation, and we will continue to hold ourselves accountable for delivering on the responsibility.

Hurrah.  But one must add, “yes, but additional Congressional oversight might help too.

There seems to be an inability (or a desire?) to openly discuss the importance and urgency of collaboration with industry.  Consider this segment under the header, “Innovation/Collaboration” –

We have gained substantial knowledge through more than 100 years of building regulatory programs to ensure the safety and integrity of foods, medical products, and cosmetics. But we also recognize that the promises of science and technology require us to seek new approaches to performing our mission, particularly because competition for scarce public resources makes it difficult to simply scale-up past solutions to meet rising demands. By investing in the field of regulatory science, FDA is fostering innovations that we hope will enhance our effectiveness and productivity for years to come.

We cannot achieve our vision and address the challenges of the 21st century by working alone. To make rapid and efficient improvements in public health and drive innovation, we must harness the best ideas from a broad range of stakeholders and leverage resources through collaboration with other federal, state, and local regulatory and public health agencies; non-government organizations; consumer and patient organizations; academic medical centers and research universities; the private sector; and the public. For example, FDA is collaborating with state and local food safety authorities to develop standards and training that will establish a more integrated and coordinated national food safety system.

The Critical Path Initiative (CPI), an agency effort to modernize the sciences for developing, evaluating, manufacturing, and using FDA-regulated products, has long recognized the importance of collaboration to leverage critical expertise and resources in driving scientific innovation. Building on CPI, FDA’s Advancing Regulatory Science Initiative recently established a formal collaboration with the National Institutes of Health to advance regulatory science and build the capacity needed to ensure the safety and effectiveness of innovative new products and technologies.

One assumes that by “the private sector” the agency means “regulated industry.”  So why don’t they say so?  Why the need for code language.  At the end of the day, if you can’t say it, you won’t do it.  This is particularly disturbing relative to the Critical Path Initiative.  And here’s a question – why do the words “Reagan/Udall not appear anywhere in the report?

The full report can be found here.

And enjoy the read.

  Read More & Comment...

Our transatlantic cousins doth protest too little

04/21/2011 10:59 AM |

Good news! The UK’s Code of Practice regulator has issued guidance on social media and other digital communications tools.

Bad news!  There’s precious little relevance for American marketers.

Nevertheless …

The PMCPA has put together a Q&A document to explain how digital communication fits into its existing regulations. It took this step, rather than amend UK pharma’s self-regulatory Code, because “there have been few complaints about digital communication.”

Ah, our transatlantic cousins doth protest too little!

The Q&A document explains the place of digital communication tools within the existing rules, which ultimately comes down to companies can use digital media if they stick to the Code. It also adds particular emphasis on the Code’s existing ban on promoting prescription-only medicines to the public. “Therefore, pharmaceutical companies need to identify ways of utilising digital communications whilst complying with this restriction."

The PMCPA’s Q&A can be found here.

  Read More & Comment...

Pear Fare

04/20/2011 08:44 AM |

Obama Panel to Curb Medicare Finds Foes in Both Parties

By ROBERT PEAR

WASHINGTON — Democrats and Republicans are joining to oppose one of the most important features of President Obama’s new deficit reduction plan, a powerful independent board that could make sweeping cuts in the growth of Medicare spending.

Mr. Obama wants to expand the power of the 15-member panel, which was created by the new health care law, to rein in Medicare costs.

But not only do Republicans and some Democrats oppose increasing the power of the board, they also want to eliminate it altogether. Opponents fear that the panel, known as the Independent Payment Advisory Board, would usurp Congressional spending power over one of the government’s most important and expensive social programs.

Under the law, spending cuts recommended by the presidentially appointed panel would take effect automatically unless Congress voted to block or change them. In general, federal courts could not review actions to carry out the board’s recommendations. The impact of the board’s decisions could be magnified because private insurers often use Medicare rates as a guide or a benchmark in paying doctors, hospitals and other providers.

Last week, in his speech on deficit reduction, Mr. Obama said he wanted to beef up the board’s cost-cutting powers in unspecified ways should the growth of Medicare spending exceed certain goals. Supporters say the board will be able to make tough decisions because it will be largely insulated from legislative politics.

Lawmakers do not agree. Representative Paul D. Ryan, Republican of Wisconsin and chairman of the House Budget Committee, called it “a rationing board” and said Congress should not “delegate Medicare decision-making to 15 people appointed by the president.” He said Mr. Obama’s proposal would allow the board to “impose more price controls and more limitations on providers, which will end up cutting services to seniors.”

Senator John Cornyn, a Texas Republican who introduced a bill last month to repeal the Medicare board, said the president’s proposal “punts difficult decisions on health spending to an unelected, unaccountable board of bureaucrats.”

Representative Allyson Y. Schwartz, a Pennsylvania Democrat prominent on health care issues, said: “It’s our constitutional duty, as members of Congress, to take responsibility for Medicare and not turn decisions over to a board. Abdicating this responsibility, whether to insurance companies or to an unelected commission, undermines our ability to represent our constituents, including seniors and the disabled.”

Ms. Schwartz signed up on Friday as co-sponsor of a bill to repeal the board.

The purpose of the panel, according to the health care law, is to reduce the rate of growth in Medicare spending per beneficiary. The law sets annual goals — “target growth rates” — for Medicare spending below the average of the last 15 years.

Board members will be subject to Senate confirmation — no easy feat in the current political climate. Terms are six years. Members can serve no more than two full consecutive terms. The White House has yet to submit any nominations for the board.

“Why have legislators?” asked Representative Pete Stark of California, the senior Democrat on the Ways and Means Subcommittee on Health.

In some ways, Mr. Stark said, expanding the power of the board could be as bad as giving vouchers to Medicare beneficiaries to buy private insurance. “In theory at least, you could set the vouchers at an adequate level,” he said. “But, in its effort to limit the growth of Medicare spending, the board is likely to set inadequate payment rates for health care providers, which could endanger patient care.”

Representative Shelley Berkley, Democrat of Nevada, said she wanted to repeal the Medicare board. “I have great faith that this administration can put together a strong, independent and knowledgeable board,” Ms. Berkley said, but she said she had less confidence in future administrations.

Mark Parkinson, president of the American Health Care Association, which represents nursing homes, said his members disliked the board because it would allow Congress and the president to “subcontract out difficult decisions.”

Still, the idea of a more potent Medicare board could be a live option if the White House insisted on it in budget negotiations with Congress.

Mr. Obama said last week that he would “reduce wasteful subsidies and erroneous payments,” cut spending on prescription drugs and take other steps to save $500 billion in Medicare and Medicaid by 2023. “But if we’re wrong and Medicare costs rise faster than we expect,” he said, the Medicare board would have “the authority to make additional savings by further improving Medicare.”

The president’s proposal would set stricter goals for Medicare spending and establish some type of automatic cost-cutting device as an “enforcement mechanism,” but Mr. Obama did not say exactly how it would work.

Kathleen Sebelius, the secretary of health and human services, described the board as a backstop to “ensure that health costs are reduced.” The board might not have to take action if the president’s other proposals slow the growth of Medicare spending, she said.

The board grew out of proposals by Mr. Obama and Senator John D. Rockefeller IV, Democrat of West Virginia.

“Medicare payment policy should be determined by experts, using evidence, not by the undue influence of special interests,” Mr. Rockefeller said.

AARP, the American Medical Association and the American Hospital Association voiced concern about the president’s latest proposal.

“Relying on arbitrary spending targets is not a good way to make health policy, especially when decisions may be left to the unelected and unaccountable,” said A. Barry Rand, chief executive of AARP, the lobby for older Americans.

Under the law, the board cannot make recommendations to “ration health care,” raise revenues or increase beneficiaries’ premiums, deductibles or co-payments. This increases the likelihood that the board will try to save money by trimming Medicare payments to health care providers.   Read More & Comment...

Statistics Ballistics

04/20/2011 08:39 AM |

Oodles of fascinating and important data on the use of medicines in the United States hot off the presses from the IMS Institute for Healthcare Informatics.

And the policy implications are enormous.

Some tidbits to jump start your cogitation process:

* Medicare Part D beneficiaries filled 871Mn prescriptions in 2010, up 6.4% and accounting for nearly 22% of all prescriptions.

* Spending on branded drugs totaled $229Bn, but declined by 0.7%, while spending on unbranded generics increased 21.7% and branded generics by 4.5%.

* Spending on medicines mainly dispensed by primary care physicians grew by 0.5%, while those medicines primarily used by specialists grew by 4.8%.

* Small molecule spending totaled $240Bn, an increase of 0.5% as biologics grew by 6.6%, amounting to $67Bn.

* Spending on drugs through retail channels increased by 2.0%, while institutional channels rose by 3.0%.

* Oral forms of medicines declined by 0.1%, but spending on injectables increased by 5.7%.

* New therapy starts for 17 chronic conditions declined by 3.4Mn patients in 2010.

* 3.2Mn more patients started their therapy with a generic while 6.6Mn fewer patients started therapy with a brand.

* Continuations and refills within 17 chronic therapy areas increased by 6.7Mn in 2010.

* Generic continuations increased by 11%, or 67.8Mn in 2010, and now represent about two-thirds of all continuations.

* The number of brand continuations declined by 12% or 61Mn prescriptions in 2010.

* The top 5 classes in 2010 based on spending were oncologics ($22.3Bn), respiratory agents ($19.3Bn), lipid regulators ($18.7Bn), antidiabetes (16.9Bn) and antipsychotics ($16.1Bn).

* Absolute spending growth gains were highest for antidiabetes, antipsychotics, respiratory agents, HIV antivirals and autoimmune disease.

The complete report can be found here.

  Read More & Comment...

Keeping abreast of EMA goings on

04/19/2011 02:02 PM |

Roche has managed to reverse the European Medicines Agency's rejection of use of Avastin in combination with capecitabine for treatment of first-line metastatic breast cancer.

While this is a different indication than the one under appeal with FDA, the success of overcoming the regulator's concerns with a re-presentation of the data and an oral defense can only be confidence boosting as Genentech prepares for a similar interaction with FDA on combination use with paclitaxel, which is supported by better data.

The CHMP issued a positive opinion on April 14 on the indication for use with capecitabine, though with a limitation. The summary of product characteristics will restrict use to patients in whom other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate. Further, patients who have received taxane or anthracycline-containing regimens in the adjuvant setting within the last 12 months should also be excluded, CHMP decided.

CHMP's original decision not to allow the indication was issued Dec. 16, 2010 - the same day that FDA similarly decided against a label expansion for use in combination with capecitabine, but more importantly, also announced it was moving to withdraw the metastatic breast cancer indication for Avastin in the U.S.

The initial breast cancer approvals were based on a strong progression-free survival advantage when used with paclitaxel chemotherapy in the E2100 study. Roche subsequently submitted other studies with different chemotherapy combinations - AVADO with docetaxel and RIBBON1 with capecitabine (Roche's Xeloda).

But those other studies failed to live up to the magnitude of the benefit in E2100. EMA had granted a full approval for Avastin use in combination with paclitaxel and decided the new findings did not impact that determination. FDA, however, had issued an accelerated approval on the condition that the other studies confirmed the benefit. When that didn't happen, it decided to rescind the approval - an action Genentech is now appealing.

The proposed label expansions based on the AVADO and RIBBON1 studies were denied by both EMA and FDA. While Genentech's efforts in the U.S. are currently aimed at keeping the paclitaxel indication, in Europe Roche requested a re-examination of the capecitabine indication.

  Read More & Comment...

A little more than kin, and less than kind.

04/18/2011 07:43 AM |

The closing speaker at least week’s PhRMA annual meeting (aka, the “Pharmitzvah”) was Renaissance Man Fareed Zakaria. He gave a wonderful view of the current global economic and political landscape and was in equal parts equally euphoric about the potential and brutally honest about the challenges.  Most interesting were his views on the changing nature and role of the nation state.

His was the only presentation that permitted audience participation and I was fortunate enough to ask the first question, “What is the role of the 21^st century nation state when it comes to the future of healthcare?”

His answer was as dynamic as it was simple, “The x factor is innovation.”

Specifically, he believes that for a nation to be a global healthcare leader, said nation must invest its national treasure in innovation. He chose as exemplars Singapore, China, India and South Korea.  The percentage of public wealth invested by the United States doesn’t even begin to match up with that fearsome foursome.  Zakaria also pointed out that the difference between research facilities in Beijing and Cambridge isn’t quality … it’s cost.

In other words, not only are other nations investing more – they’re getting more bang for the investment yuan. All this at the same moment that President Obama disrespects pharmaceutical innovation by suggesting that we reduce the patent life of biologics from twelve years to seven.

In his closing remarks, PhRMA Chairman Chris Viehbacher summed it up nicely, “The question isn’t will our companies be successful? It’s will they continue to be successful in the United States?”

To be or not to be, that is the question. 

It certainly puts the slings and arrows into perspective.

  Read More & Comment...

Pharmitzvah in Jersey City

04/15/2011 06:19 AM |

Greetings from the 53^rd annual PhRMA Annual Meeting in jaunty Jersey City. No beach. No golf. No swag.  Just a lot of content.

Some samplers from the Pharmitzvah bima:

PhRMA Chairman (and sanofi-aventis chief) Chris Viehbacher, “As I was walking up to the podium, I was asked if I needed anything.  I said, how about a President and Congress that understands the need for a research-based pharmaceutical industry.”

Quite germane and timely considering President Obama’s speech on Wednesday. (For more on that speech see here).

Viehbacher teed-up the meeting by calling on all present to embrace “the three t’s” of truth, trust and transparency.  He also mentioned that, alas, there is not (at least as of yet) “a billing code for prevention.” Amen Brother Chris.

Later on we heard a pretty dynamic speech from Governor Chris Christie who insisted that he is (and we should all be) about “results over politics.”  Amen Brother Chris.

Governor Christie was followed by our 42^nd President, William Jefferson Clinton, who came on stage saying that he wanted to say something nice about the Governor, “but didn’t want to ruin his (Christie’s) reputation.” He then proceeded to give a rambling (by which I mean, charitably, eclectic) speech. Whatever he was paid it was too much -- unless he was paid by the word.

The luncheon speaker was Mike Krzyzewski (“Coach K”) who gave a very stirring and emotional talk, largely about his experience coaching the Olympic and World Championships basketball teams.  His philosophy of “standards not rules” resonated. (And his jibes about Kobe Bryant – who reneged on a promise to attend Duke after high school – were priceless.)

John Castellani, now eight months into his job as PhRMA President, captured the frustration of the crowd when, in commenting on the current political environment, quoted Oscar Wilde -- “A cynic knows the cost of everything and the value of nothing.” Nuff said. 

Amen Brother John.

  Read More & Comment...