What can Brown do for you?

06/20/2008 11:54 AM |

Senator Sherrod Brown (D, OH) thinks that pharmaceutical companies are taking advantage of lower safety standards in countries like China and India to lower costs and has also asked Pfizer for details of its outsourcing to countries without the same drug safety standards as the US.

It should also be noted that this is the same Sherrod Brown who supports drug importation.

In a letter to Janet Woodcock, the Senator referred to her testimony to the Senate Committee on Health, Education, Labor & Pensions (HELP) where she had said that drug companies outsource because of "different governmental regulations in different parts of the world", "lower, less stringent standards in some parts of the world", and lower labor costs in developing countries.
The senator has asked Dr Woodcock for details of the volume of outsourced drug ingredients, the added costs of regulating outsourced ingredients, and the 'bearer' of those costs. He has also asked for measures to hold companies accountable for outsourcing.

Perhaps Senator Brown is contemplating user fees for foreign inspections?

In a separate letter to Pfizer, the Senator asked about the drugmaker's annual savings through outsourcing and a list of instances where Pfizer has outsourced manufacturing due to lack of technical expertise.

That former list should be pretty short. Hopefully Pfizer will also discuss the technical expertise it provides.

What can Brown do for you?  Read More & Comment...

Rank Amateurs

06/20/2008 11:07 AM |

Good piece by Jerry Norris (Hudson Institute) in today's FT:

A way to rank access to medicines
by Jeremiah Norris,
The Financial Times

USA, 6/20/2008 - Sir, Wim Leereveld (reports, June 16) has started an interesting and potentially important metric to judge how pharmaceutical companies are making drugs available and affordable to the poor. His Access to Medicines index says that GSK leads the pack in this regard. It isn’t obvious from his methodology whether he has been able to separate monetary value of products from their clinical value, or to ascertain how product donations spurned significant financial leverage from other actors.

For instance, Merck is ranked number 3. It has been contributing Ivermectin to combat river blindness for the past 20 years. The product itself is fairly inexpensive and is administered once yearly. Yet, it produces a clinical value to millions of people by preventing blindness. Once the corporate contribution was made, the World Bank syndicated it among a wide array of donors, investing at least $250m in the process. Another indirect benefit is that, according to a Bank evaluation, when farmers returned to their previously abandoned river villages, 17m hectares of land were reclaimed, enough to feed 25m people. The index states that companies score “least strongly for researching neglected diseases”. GSK has been a leader in this arena, building a $235m research and development facility in Spain to develop products identified by the World Health Organisation as “essential medicines” for the poor. Novartis has built a tropical disease research institute in Singapore, targeting only malaria, TB and chagas disease. It recently built a vaccine institute in Italy to work on neglected diseases. Pfizer constructed an Infectious Disease Institute in Uganda. It has now trained 40 per cent of the country’s physicians in Aids treatment and care. At present, 24 countries have sent staff to this institute for similar training. In these research facilities, the operating costs have by now far exceeded the capital costs.

However difficult, Mr Leereveld would want to strengthen his methodology in the future. This would allow a more comprehensive comparison between companies. They could then better position themselves and, measure for measure, determine where they really stand in the rankings on corporate social responsibility.

Jeremiah Norris,
Director,
Center for Science in Public Policy,
Hudson Institute,
Washington, DC 20005, US  Read More & Comment...

DeMint Julip

06/20/2008 10:49 AM |

We visited with Senator Jim DeMint (R, SC) and asked him about the future of American healthcare.  What he told us is worth sharing:

www.vimeo.com/1187943

And his closing line (an ad lib!)  is an instant classic.  Read More & Comment...

CLIA? Glad to see ya.

06/19/2008 01:29 PM |

There’s so much going on at the BIO convention. It’s a healthcare policy feast.

One panel I attended was on the future of personalized medicine via diagnostics. A few of the points made were:

• At present, “trial and error medicine” is the standard of care. Not good for providers, patients, nor payers. That’s true.

• What we today call “personalized medicine” will be referred to in the near future as “medicine.” That’s hopeful.

• Diagnostics will deliver personalized care via drug selection, dosing, efficacy, disease status, recurrence risk, and predisposition. That’s exciting.

• Diagnostics lead the league in the price/value proposition – and that’s what will initially drive uptake. That’s reality.

• To that point, there was also discussion of a diagnostics acceptance continuum beginning with “fear” and then moving to “value” and finally “acceptance.”

• And the constituencies moving along that path include pharmaceutical companies, physicians, patients, payers – and regulators.

• Specifically, to more expeditiously sashay down the Critical Path, the diagnostics industry needs industry-wide guidelines for clinical research.

Take-away is that "personalized" medicine is 21st century medicine. And that's a "win" for physicians, payers ... and even patients. As BIO Chairman (and Vertex CEO) Dr. Joshua Boger commented at the opening day's keynote, we must all be "a confederation of optimists."
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Must see TV, eh?

06/18/2008 02:01 PM |

According to PharmaTimes, CanWest Mediaworks, Canada’s largest newspaper publisher and owner of more than 30 television stations, is suing the federal government for not permitting direct-to-consumer advertising of prescription drugs because, it says, this breaches its freedom of expression under Canada’s Charter of Rights and Freedoms.

CanWest is arguing in the Ontario Superior Court that this prohibition, which is part of the Canadian Food and Drugs Act, places it at a competitive disadvantage to US newspaper and magazines which are sold on Canadian newsstands, because it prevents it from selling advertising space to pharmaceutical manufacturers. The company also points out that Canada does allow OTC medicines to be advertised directly to consumers, even though these products also carry risks.

The case will be heard this month.  Read More & Comment...

Missing the Personalized Medicine Message in the Elan Results

06/18/2008 12:57 PM |

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Peripheral Vision Check at the AMA

06/18/2008 09:45 AM |

On Monday the AMA House of Delegates soundly rejected the recommendations of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine. The report echoed the Macy Foundation Report's recommendation to remove all commercial support for medical education.

Earlier in the day the Reference Committee on Amendments to Constitution and Bylaws recommended the CEJA report “for referral" so that it will not be presented on the house floor for a vote.

Since the Reference Committee did not recommend “not adoption,” CEJA can revise and (improve) their report for presentation at a later meeting as soon as this time next year. However, given the strength of almost unanimous opposition to the recommendation, it’s not likely come back to the House of Delegates anytime soon.

At the reference committee hearing on Sunday only two speakers spoke in favor of adoption of the report; the current CEJA chairman, Mark Levine, MD, and one other physician( unaffiliated).

According to our roving correspondent, when Dr. Levine stood up at the microphone to present his committee’s report he told the Chairman of the reference committee, Dr. Raymond Christenson, that he wouldn’t take up much time given that all those behind him in line were in favor of the proposal -- at which the chairman commented, “Dr. Levine there is no one behind you, so take your time.”

What time is it when Dr. Levine can’t see his shadow? Time to toss in the towel.

One of the strongest, most consistent, and eloquent voices against the CEJA proposal was Dr. Tom Stossel, American Cancer Society Professor of Medicine at Harvard Medical School.

We recently visited with Tom in his Boston office. Here’s a link to the video podcast:

www.vimeo.com/1186974

Take your time Tom; we’re all behind you.
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Comparative Effectiveness Kills

06/17/2008 02:12 PM |

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BigGovHealth.org

06/16/2008 12:12 PM |

In our post-SiCKO, pre-election environment, the Center for Medicine in the Public Interest is launching a new program that takes a careful and candid look at just what you get via government-run (aka "Universal") healthcare.

We call our project BigGovHealth.org.

We're beginning our initiative with a short movie that, we believe, shows why Big Government healthcare is the wrong prescription for the United States.

Please join us for the Washington, DC premiere on June 23 , from 6:30 - 8:00PM, at the National Press Club.

We will be joined by Congressman John Shadegg, former Senator Don Nickles and other healthcare players (we've even gotten an RSVP from a presidential candidate).

The complete invitation, along with RSVP information, can be found at the top of this page

When it comes to healthcare reform, BigGovHealth.org is Cinéma-vérité.
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Stipulating Bias

06/13/2008 12:37 PM |

According to a new editorial in the Lancet, “From February to April this year, the European Commission (EC) held a public consultation on proposed legal changes that would allow pharmaceutical companies to provide information to patients about prescription-only drugs via all available media. The Commission's proposal states that the ban on direct-to-consumer advertising (DTCA) in Europe would remain. However, many critics rightly feel that allowing the industry to provide information to patients is effectively DTCA under a different name.”

Who are these critics?  What are the agendas?  Where does their funding come from?  On these questions the Lancet is silent.

The Lancet opines, “Patients' access to quality information is variable across the European Union's 27 member states and the Commission is right to want to address this inequality. But the pharmaceutical industry's obvious financial conflicts of interest mean that drug information provided by them is likely to be prone to bias.”

“Likely to be biased?”  On what do they base this rather strong statement?  Isn’t solid, unbiased information in the best interests of both sales and the public health? Isn’t there a more inherent “bias” by having payers control what information consumers get to see?  And in the EU, “payers” = “government.”

The editorial concludes, “Patients have a fundamental right to access good quality, objective information on medicines. The EC's final proposal, due out later this year, must empower patients and not the drug industry.”

Why not empower the drug industry to empower patients?  That’s what the pending EC directive is all about.

And as far as the Lancet stipulating bias, consider the words of Robert Benchley:

"Tell us your phobias, and we will tell you what you are afraid of."

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Reporting from the Planet Mercury

06/13/2008 12:29 PM |

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Attack of the Killer Tomatoes IX

06/13/2008 03:09 AM |

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Ray of Hope on Critical Path

06/13/2008 02:19 AM |

While the media covers the Grassley stains and Stupak remarks oozing from Congress, Ray Woosley and the C-Path Institute with strong backing from Janet Woodcock at the FDA are remaking the drug development process, transforming it from a hit or miss method to a pathway for personalized medicine. Today C-Path announced a trans-atlantic agreement to use the same drug safety biomarker at the FDA and the EMEA, a historic first. And let's not forget that industry is collaborating, much to the consternation of DeLauro,Goozner, Mahar, Brownlee and pharmalot. Progress towards safer, more effective medicines using more reliable measures. Oh, the humanity.

Read more here

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Have NICE Life

06/12/2008 08:13 PM |

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Two Part Harmony

06/12/2008 05:08 PM |

New from the FDA ...

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety

Collaborative effort by FDA and EMEA expected to yield additional safety data

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or “biomarkers” found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

The new biomarkers are KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA.

“The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs.”

Woodcock added that such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products.

Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA.

The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process.

The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers.

FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. For example, in experiments using rats, the two traditional tests can only detect kidney damage a week after it has begun to occur. The new tests, however, are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected.

The seven new tests were developed and will be carried out initially in rats. These tests were selected because other studies have shown that identical biomarkers are produced in human kidney cells. While the FDA and EMEA will consider these biomarkers in rat studies initially, the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.

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Medical Students On the Take From Tort Lawyers

06/12/2008 02:20 PM |

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Nailing Nissen

06/12/2008 01:49 PM |

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Max Senate

06/12/2008 01:18 PM |

Here's a safe prediction about our next President -- He'll be a Senator.

To that end, we thought it would be interesting and important to see what some of the elite 100 think on the topic of American healthcare reform.

So we asked.

Have a look at two new video podcasts with Senator Richard Burr (R, NC) and Senator Bob Corker (R, TN).

Here are the direct links:

Senator Burr: www.vimeio.com/1148600

Senator Corker: www.vimeo.com/1155911

Other newsmaker podcasts can be found at www.cmpi.org




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Patients are a Virtue

06/12/2008 12:50 PM |

New York State Assemblyman Richard Gottfried has introduced a bill that would place severe restrictions on those who sell prescription drugs.

The goal, no doubt, is to appear tough with drug companies. Given the rising cost of health care, this is politically understandable. Unfortunately, the proposed bill would only make doctors' jobs harder -- depriving them of vital information and undermining their ability to make the best clinical decisions possible. Ultimately, patients will pay the price.

Read the full op-ed from today’s edition of the Albany Times-Union

This back-handed attempt to prohibit off-label prescribing is nothing more than yet another inappropriate government intervention into the doctor's office. Gottfried's bill may make for good political theater, but the grandstanding ignores a fundamental truth: Doctors, not bureaucrats, know their patients' medical needs best.

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Now Pitching for the Yankees....

06/11/2008 10:42 PM |

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