Is There a Downside to a Drug Ad Ban?

04/18/2007 12:39 PM |

What if fewer people find out about important new medicines while at the same time critics pan new products and scaremongers push panic about side effects leading to those quacks who sell to good to be true cures to rake in profits at the expense of the sick and scared?

Power abhors a vacuum. So does information.  Read More & Comment...

David Graham: Public Health Enemy

04/18/2007 09:17 AM |

In the wake of the terrible tragedy at Virginia Tech comes yet another study demonstrating that the use of anti-depressants in adolescents -- carefully monitored -- are useful in treating various forms of depression, anxiety, panic disorder, etc. No major paper or media outlet which gave David Graham or others front page coverage of the threats or the misrepresentation of the dangers of SSRIs are now giving the benefits of these medications the same top of the fold treatment.

For those of you who want to see how such fear mongering can lead to a decline in the use of effective treatment and therefore an increase in violent behavior that in fact leads to suicide and tragic death, we now present one Graham's typical statements on SSRI's

"With the SSRIs [Selective Serotonin Re-Uptake Inhibitors, the class of antidepressants including Prozac and Paxil], I think FDA pulled a fast one on the American people. Because they said, �we are using our most powerful labeling, our most powerful medicine: we�re putting a black box around it.� But it doesn�t change physician behavior. People are as unsafe after the labeling goes into effect as they were before.

With the SSRI labeling, people are actually more deceived. Because the labeling says that the risk of suicidal thoughts and behavior in children is 1-2 percent. But FDA�s own senior managers admitted at an open public advisory committee meeting that our clinical trials don�t capture suicidal thoughts and behavior. So what we know about it is what has been voluntarily reported. There are lots more out there, we just didn�t measure them. They have evidence from an NIH clinical trial that the risk is more like 8 percent. "
http://multinationalmonitor.org/mm2004/122004/interview-graham.html
Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.  Read More & Comment...

Stabenow-nothings in Congress

04/18/2007 07:29 AM |

My latest oped on how Democrats (mostly, but not all) -- led by the incredibly clueless Debbie Stabenow -- are subverting medical science (and proper spelling) for the sake of ideology in the area of pharmaceutical regulation. And it's going to get worse this week and the next when the same Jacobins seek to destroy what is now sensible drug safety legislation with amendments on drug importation and other nonsense. Maybe AARP will offer me another pedometer for calling my Congressman on these important issues.

Or maybe not.

http://washingtontimes.com/op-ed/20070417-091721-8233r.htm  Read More & Comment...

Gates to the Critical Path

04/18/2007 06:57 AM |

A new IMS Health report posits that, “The billions of dollars thrown at global health problems by the Bill & Melinda Gates Foundation are changing the game in drug discovery, posing big challenges to the world's top drug makers.”

"Pharma companies need to develop an explicit strategy to deal with this phenomenon," IMS said in its annual Intelligence.360 report on factors shaping the industry.

According to the report, the foundation’s $60 billion gives it plentiful resources to compete in the medical research arena with both government-funded institutions and commercial pharmaceutical firms.

IMS believes that, even if drug companies succeed in making key discoveries first, they may still find it attractive to partner with the Gates Foundations, from a practical and public relations point of view.

Well, that’s all to the good – but what the report doesn’t mention is that discovery and development is still a very difficult proposition.

Drugwonks challenges the Gates Foundation to become a major player in the FDA’s Critical Path program – because the best way to get new cures to market faster is to develop the 21st tools required to expedite discovery and development.

Here’s the link to the Reuters story on the IMS report:

http://news.yahoo.com/s/nm/20070417/hl_nm/gates_pharmaceuticals_dc_1  Read More & Comment...

statin drugs

04/17/2007 10:51 PM |

Late last month, an important study in JAMA showed that patients in a high LDL cholesterol group from 130 to 160 did not show a progression of carotid plaque when receiving rosuvastatin compared with control. This study was a breakthrough in terms of primary prevention though the results are not surprising, and many internists, myself included, were already treating many of the members of this group with statins. Carotid plaque is predictive of coronary plaque, and previous studies have shown plaque stabilization with atorvastatin in patients with heart disease leading to a diminishing of subsequent cardiac events. (secondary prevention)

Here is the new JAMA study on rosuvastatin - it would be interesting to follow this up with a study that looked at whether bringing down LDL to less than 80 with diet alone, gave the same results in terms of plaque as when a statin is used.

http://jama.ama-assn.org/cgi/content/full/297/12/1376  Read More & Comment...

HELP Desk

04/17/2007 10:52 AM |

Markup tomorrow for the Food and Drug Administration Revitalization Act. No importation codicil – but, unfortunately, it may yet appear as a floor amendment.

Some topline highlights:

Title I -- Prescription Drug User Fees

Title I establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs.

Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.

Title II -- Drug Safety

Subtitle A -- Risk Evaluation and Mitigation Strategies (REMS)

This subtitle establishes a system of routine active surveillance for post-market drug safety through a public-private partnership. The partnership will aggregate data from Federal and private health databases containing information for at least 100,000,000 covered lives and support the analysis of utilization and safety data from these databases. The establishment of this system will be supported with up to $30 million in appropriations.

Given the ability of this active surveillance system to identify and assess drug risks, most drugs and biologics will not need anything further than this system and the drug label to appropriately manage risk. However, some drugs and biologics will need additional tools to manage serious risks, and these products will be approved with risk evaluation and mitigation strategies (REMS). Sponsors would propose a REMS and FDA would approve it after structured negotiations, if necessary. The REMS will be reviewed at 18 months and three years, as well as in labeling supplements and when FDA requests a review.

Additional Elements —When more is needed, a REMS may include tools to assess, communicate about, or manage risks. The bill contains clear standards detailing the appropriate application of each tool. These standards ensure that new FDA authorities are applied narrowly, and only as necessary.

A REMS would be assessed in response to new information about a serious risk, and could be modified, including by reducing the stringency of elements, in response to new information.

Resources -- Increased drug user fees would be used to review REMS and for FDA’s general drug safety surveillance. This subtitle increases user fee revenue by $50 million over the agreement between industry and the FDA to fund drug safety activities.

Subtitle B -- Reagan-Udall Foundation for the Food and Drug Administration

Subtitle B establishes a foundation to lead collaborations amongst the FDA, academic research institutions, and industry directed to supporting the FDA’s mission. Collaborative research projects will be selected that are designed to bolster R & D productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make regulated product development and safety more predictable and manageable. The Foundation will be financially supported by industry and philanthropic donated funds.

Subtitle C -- Clinical Trials

To enhance patient enrollment and provide a mechanism to track subsequent progress of trials, the data bank at www.clinicaltrials.gov will be expanded to include all phase II and later trials, and to include devices. Currently, only clinical trials of drugs for serious and life threatening conditions are required to register in the data bank.

In addition, to ensure that results of trials are made public, and that patients and providers have the most up-to-date information, results information would be added to this database. Information would be added only after the product in question has been approved or cleared for marketing. Results information would first come from existing FDA and NIH documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured under those conditions.

Subtitle D -- Conflicts of Interest

Subtitle D requires disclosure of conflicts of interest of advisory committee members prior to an advisory committee meeting, and greater efforts by FDA to identify and recruit members of advisory committees.

Title III -- Medical Device User Fees

Title III is reflective of the agreement between FDA and industry regarding the total list of issues within their agreement from the time of the publication of the Federal Register notice. Given that some of the submitted language does not track the intent of the agreement, we expect to provide further improvements to the language at a later date. Those improvements will be agreed to by both FDA and industry.

Per the agreement between FDA and industry, it establishes an overall amount of $287 M of user fees over five years, with $48 M in 2008. This is coupled with a fixed 8.5% annual increase (with no other adjustors) and a further reduction of fees for small business.

Title III also includes the FDA-industry proposal on third party inspection improvements to ensure that the program works more efficiently and clarifying that entities can register and list electronically.

Title IV -- Pediatric Medical Products

Subtitle A -- Best Pharmaceuticals for Children

Subtitle A would reauthorize the Best Pharmaceuticals for Children Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations. BPCA generally provides six months of additional exclusivity to drug manufactures to encourage the determination of safety and efficacy of drugs in pediatric populations. The bill contains an incentive of three months of additional exclusivity if US sales of the active moiety by the innovator and its affiliates exceed $1 billion annually at the time written request for study is issued. The bill is a five-year authorization and will expire in 2012. No PDUFA funds can be used for BPCA studies. The Secretary may send declined requests for study to the NIH Foundation if funds are available.

Subtitle B -- Pediatric Research Improvement

Subtitle B would reauthorize the Pediatric Research Equity Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations.

In order to improve coordination with the pediatric exclusivity provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA would consolidate an internal FDA committee to review all issues of pediatric-related labeling and assessments. Doing so ensures that a drug that falls under PRIA or BPCA is reviewed not only by experts for that particular drug, but experts with pediatric expertise. PRIA will sunset in tandem with BPCA in 2012. If a company chooses not to pursue pediatric exclusivity for an already marketed drug under the Best Pharmaceuticals for Children Act, and no study is performed through NIH, then the Secretary has the authority to require the submission of pediatric data for such drug. PRIA streamlines this process and helps get essential pediatric data for important drugs, while preserving the ability of companies to meet and discuss testing with the agency.

The bill would require two reports – one from the Institute of Medicine and one from the GAO – that would allow us to have better data on the number and ways in which the pediatric rule is used, and evaluate its contributions to ensuring overall pediatric drug safety.

Subtitle C -- Pediatric Medical Devices

Subtitle C modifies the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need. Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. No profit will be allowed for a device used in more than 4,000 individuals. The HDE exemption expansion sunsets in 2013 and a GAO report assessing the HDE exemption expansion and its impact on patients and manufacturers is required.

The FDA’s Office of Pediatric Therapeutics will acquire enhanced authority to collaborate with NIH, AHRQ, and subject matter experts in order to assess pediatric device R&D needs.

Demonstration grants, with tracked results, will be established for non-profit consortia to promote pediatric device development, manufacture and distribution. The bill grants explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety. This approach incorporates several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.

Still plowing through the details – more to follow.

FDA package posted here:

http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf

Have a look and let the debate begin!  Read More & Comment...

Hey AARP Where's My Pedometer?

04/17/2007 10:18 AM |

In an effort to entice me to join, AARP has sent me two emails a day offering me a free pedometer if I become a member. That is one email more a day than I get from the site offering me soft-tab Cialis. AARP has also sent me emails urging me to join in a national call in to support Medicare price controls but there was no toll free number. What if I was on a fixed income and had to choose between food and a phone call?  Read More & Comment...

Golden Years

04/17/2007 07:59 AM |

"AARP Says It Will Become Major Medicare Insurer While Remaining a Consumer Lobby"

That's the headline in today's New York Times story by Robert Pear. The pull quote is more interesting: "Potential for conflicts is seen as a lobbyist plans to expand its insurance role."

Conflicts? Non-issue says AARP. According to the Times story, "AARP officials insisted that its financial interests do not affect the positions it takes on Medicare, Medicaid, Social Security and dozens of other issues on which it lobbies and litigates."

Try this exercise -- take the above paragraph and replace "AARP" with "the insurance industry" and read it out loud.

So, let's pick two items: non-interference and drug importation. AARP supports the revokation of the non-interference clause and supports drug importation. Hmm. Major insurance provider supports price controls both legislated and imported. Conflict?

You be the judge.

On the up side, "the new plans will coordinate care for people with chronic conditions and will develop special programs to treat people with depression."

Big Pharma could learn a lot about spin control from spinmeitster/AARP CEO Bill Novelli.  Read More & Comment...

Yom HaShoa, Clinical Trials and Us

04/16/2007 04:35 PM |

The horrors of medical experimentations in the concentration camps triggered international rules designed to protect the dignity and lives of patients in scientific experiments.

The gruesome nature of the atrocities do not bear repeating. Let us honor the courage of those who survived. Let the memory who died in the Shoa be for a blessing and let us conduct our science and our lives to affirm the principle that each individual's existence has absolute value.

http://www.ushmm.org/research/doctors/twoa.htm
http://www.ushmm.org/research/doctors/Nuremberg_Code.htm  Read More & Comment...

Jerry Avorn Gets It Right on Drug Safety

04/16/2007 12:39 PM |

I am a frequent critic of Jerry Avorn on many issues, but he gets is right -- in my opinion (because I agree with him) in his editorial in Circulation.

He is off-base in his reasoning for opposing the elimination of user fees as a source of funding for FDA activities. See his article in the NEJM. While I tend to agree that user fees are becoming increasing unwieldy -- and should be replaced by public-private partnerships to advance Critical Path -- the implication that companies can't work with FDA to advance science is absurd.

Mark McClellan's editorial in the NEJM saying we have one last chance to get it right on FDA reform is on point. Pair Avorn's Circ article with Mark's NEJM and we have a sensible consensus that is Critical Path focused.

Links to all follow:

http://content.nejm.org/cgi/content/full/NEJMp078041
http://circ.ahajournals.org/cgi/content/full/113/18/2173
http://content.nejm.org/cgi/content/full/NEJMp078057  Read More & Comment...

Finding Fault With Finding More Cancer

04/16/2007 11:52 AM |

Interesting op-ed in the Washington Post raising concern about a stampede of women who will demand the use of MRIs to scope any cancer in lieu of mammograms and other screening tools in light of studies showing MRIs can catch some cancers in subpopulations and high risk patients that mammo's can't.

Let's look at the presupposition: women are hysterical and too stupid and doctors are unable to explain to women what the risks and benefits and limits of MRIs are. Also, let's look at the facts: the number of women who are seeking out mammo's for screening has declined...in part because irresponsible cults like Breast Cancer (In)action have conducted public campaign to discourage such testing....

So let's get a grip and recognize as does that article that the use of MRI's in select cases can reduce the spread of metastatic cancers and save lives or might do so. And we should research the value of such diagnostics in achieving that goal. No one is suggesting a blank check..except the scaremongers who presuppose that all patients are stupid and all doctors are patsies...

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/06/AR2007040601955_2.html?nav=rss_health  Read More & Comment...

Co-Pay's Designed to Improve Health: Maybe We Don't Have To Hold Our Breath

04/16/2007 10:04 AM |

Interesting article about United Health's PBM cutting copays to insure continued use of asthma inhalers -- as opposed to risking decreased use of Rx and increased use of more expensive services...a proposition FUSA Godfather Ron (I take money from George Soros) Pollack finds ridiculous.

The question is.. why not eliminate the huge co-pays for cancer drugs -- which have jumped many times more than the price of drugs themselves -- to promote compliance in other disease areas? Why not value driven health plans across the board? That is what evidence based medicine should really be about..

UnitedHealth cuts co-pay on asthma inhaler
RSS Feed - Health Business - Briefing
Published: April 13, 2007 at 11:07 AM
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MINNEAPOLIS, April 13, 2007 (UPI) -- U.S. health insurance giant UnitedHealthcare said Friday it has cut the co-payment for certain asthma inhalers due to high cost and short supply.

The insurer said its pharmacy benefit manager UnitedHealth Pharmaceutical Solutions has reclassified its chlorofluorocarbon-free, asthma inhaler Xopenex to its lowest co-pay tier, meaning plan members will pay between $5 and $10 for the prescription treatment.

CFC-free inhalers are gradually replacing CFC-containing albuterol inhalers, due to CFCs' environmental risks, but the CFC-free products cost more, and there are only a handful currently sold, UnitedHealth said.

The supply shortage of both generic and brand-name CFC-free inhalers is expected to increase until the complete phase-out deadline of Dec. 31, 2008, the company said.

"Asthma patients have relied on albuterol inhalers for years because they provide quick and effective relief of asthma symptoms. However, because of the higher cost for the new brand-name CFC-free inhalers, some patients may avoid continued treatment, which would place their health at serious risk," said Tim Heady, CEO of UnitedHealth Pharmaceutical Solutions.  Read More & Comment...

Revealing the "Con" in Consumer Reports

04/16/2007 07:39 AM |

Seems that at Consumer Reports, the adage “Ask me no questions, I’ll tell you no lies” has been replaced with “Ask loaded questions and there’s no need to lie.” No matter how you slice it, it equals the same thing – dishonest reporting.

Or as my grandmother used to say, "A half-truth is a whole lie."

Consider some of the findings from CR’s new survey:

* More than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect consumers from harmful prescription drugs.

As opposed to what, “safe" prescription drugs? It doesn’t look like the survey asked respondents if they understood that all drugs have risks.

Similarly:

* 84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited, with 59 percent "strongly agreeing" to such limits.

Again, as opposed to what, drugs that have no safety concerns?

* The survey also found that 84 percent of consumers agree that drug companies have too much influence over the government officials who regulate them. More than two-thirds (67 percent) are concerned that much of the FDA's funding comes from the pharmaceutical industry, with more than half--54 percent--"very concerned" about that situation.

How was this question worded? Did it make clear that PDUFA dollars fund review, not approval? I haven’t seen the survey questions, but I imagine it’s a “safe” bet that point wasn’t introduced into the protocol.

* More than half of consumers say they currently take a prescription drug, which translates to 124 million adults. A significant number -- -40 percent--say they have experienced an adverse reaction to a medication.

And what, precisely, did the survey define as an “adverse reaction?” Did they define it at all?

* Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent "strongly agreeing."

Except that every survey of doctors says otherwise.

Here’s a link to the CR press release:

http://www.consumerreports.org/cro/health-fitness/news/2007/04/consumer-reports-survey-finds-strong-backing-for-drug-reforms-4-07/overview/consumer-reports-survey-finds-strong-backing-for-drug-reforms.htm

The release, BTW, does not say who funded the study or that Consumer Reports receives significant contributions from foundations funded by the generic drug industry. Surprising, considering that another of the “research” results says that Americans are concerned about conflicts of interest. What about CR’s funding conflicts?

Might that explain why CR took a break from testing vacuum cleaners and developed a sudden interest in the public's opinions on drug safety and the FDA? Inquiring minds want to know.

Research, as the saying goes, is like a bikini. What it shows you is interesting but what it conceals is essential.

And what this survey conceals are loaded questions fielded by an organization with an agenda.  Read More & Comment...

The WSJ's Selective Questions About Merck

04/16/2007 07:24 AM |

Isn't everyone getting tired of the "Drug company's overhype products with paid for studies" angle? Or better yet, when are people going to do their own thinking on issues instead of letting journalists with an agenda do it for them?

Carreyrou tries to frame the Merck HPV vaccine mandate issue as whether it is efficacious enough to mandate it's use or more to his point, to justify Merck's effort to support mandatory immunization. He brings in statistician's to question whether it will really be effective in a group not included studied in the clinical trials.

The fact is, no vaccine designed to reduce the spread of a virus is 100 percent effective in preventing disease particularly in those with a pre-existing infection. By Carreyrou's standard then vaccines for HIV, syphillis, TB, denge, herpes should not be mandatory or by other means be part of an aggressive effort to immunize 100 percent of patients.

As my colleague Marc Siegel has pointed out time and again, HPV is a sexually transmitted disease that causes precancerous warts that lead to billions of dollars of screenings, surgeries, etc. For that alone Merck's vaccine makes an important contribution. Whether Merck should have pushed for mandatory immunization (which Peter and I support) is another question. Needless to say, anyone can play the guessing game about real world effectiveness but chances are given the mechanistic understanding of the disease as opposed to fantasy baseball analysis that the epidemiologists often take, I would bet on Merck and not a numbers cruncher John dug up.

In any event, the whole article has the sound and feel of an article from a website called corpwatch.com which lays out the case against Merck in the same way Carreyrou does including an interview with the same Maine legislator who criticizes a woman's legislative groups for taking money from Merck.

You can compare the two articles and decide which is more efficacious:

http://www.corpwatch.org/article.php?id=14401
http://online.wsj.com/article/SB117668541991270825.html?mod=hps_us_pageone  Read More & Comment...

LA. MMA. VA.

04/15/2007 08:26 AM |

Bad Scrabble tiles but good opportunity for a letter to the editor of the Los Angeles Times.

Here's what ran in today's edition:

Price controls on Medicare drugs

Re "Aid for Medicare patients sought," April 11

Although the article states that "Democrats say the government could save money if it used its massive purchasing power to negotiate with pharmaceutical companies," there is little evidence to support their claim.

First, it's not clear that allowing the government to negotiate prices would yield any savings. According to a recent report from the nonpartisan Congressional Budget Office, "Government price negotiation would not yield lower drug prices compared to current law."

Second, Democrats cite the Department of Veterans Affairs' drug benefit as a good model for Medicare Part D. But under the VA model, drug companies must sell their products to the government at a price that is at least 24% less than the non-federal average manufacturer's price. In other words, the VA institutes price controls.

Medicare covers well over 40 million seniors. If price controls are extended to such a large segment of the market, they inevitably would result in reduced consumer choices and stifled drug innovation.

PETER PITTS

Director, Center for Medicine in the Public Interest, New York  Read More & Comment...

Clinical Trials Cause Global Warming...

04/13/2007 11:04 AM |

The following article is NOT a parody. Someone actually wrote this in a serious vein and not as forced confession while being held hostage by Greenpeace...

Clinical trials are saving lives but may be killing the environment
Drug Researcher.com


UK, 4/13/2007 - Clinical trials are saving lives but may be killing the environment due to their 'intensive energy use' and 'substantial contribution to greenhouse gasses.'

Energy use in clinical research premises and trial-related air travel have been identified as the biggest culprits, in an article published in the March 31 issue of the British Medical Journal.

The situation is only set to intensify as the trend towards outsourcing various elements of clinical trials to far flung destinations all over the world continues to gain momentum.

During a one year audit period of a sample clinical trial, the total emission of greenhouse gasses related to the trial was 126 tonnes of carbon dioxide equivalents (CDEs) - an amount that corresponds to that produced by 32 people in one year on the basis of global per capita estimates, said the researchers.

For the entire five-year duration of the sample trial, about 630 tonnes of CDEs were produced - an amount that is equivalent to 525 round trips flights from London to New York for one passenger, the researchers said.

Specifically, the trial coordination centre accounted for the largest proportion of emissions, generating 50 tonnes (39 per cent), with 45 out of the 50 tonnes coming from electricity usage and the remainder from office waste disposal.

The distribution of drugs and documents was the next biggest contributor, with 35 tonnes (28 per cent) and the majority of this stemmed from the airfreight of treatment packs and documents to hospitals.

This was followed closely by trial-related travel, responsible for 29 tonnes (23 per cent) of emissions, with most coming from air travel, as well as hotel stays for site visits, on-site data verification and meetings.

Furthermore, each individual clinical trial employee was found by the researchers to generate 14 tonnes of CDEs each year, compared with the substantially-lower average of 4-6 tonnes for employees in other service industries.

The research was conducted during August 2003 and July 2004 by the Sustainable Trials Study Group, which was convened by the London School of Hygiene and Tropical Medicine to find ways of reducing greenhouse gas emissions from clinical trials.

For the purpose, a 'carbon audit' was conducted on a multicentre international trial being run by the Medical Research Council (MRC), called CRASH.

The CRASH trial involved 10,008 participants at sites in 49 countries over five years and was investigating the effect of corticosteroids on death and disability in adults with head injury.

The trial was coordinated from London; involved a drug made by Pfizer in the US; a placebo made in France; packaging of both study drugs was done in Wales, from where treatment packs were sent to London for distribution to hospitals around the world.

Commenting on the results, the researchers said: "Clinical trials are energy intensive and produce substantial greenhouse gas emissions."

"Our audit provides insights into how to reduce the carbon intensity of clinical trials."

Suggestions given include using renewable energy sources as well as more efficient energy consumption at clinical trial sites, in addition to reducing the number of staff employed, in order to cut emissions.

Other suggestions posed by the researchers were to simplify trial designs to minimise superfluous data collection, coupled with increasing the use of remote electronic data capture; reduce bureaucracy associated with ethics committee- and-regulatory applications; as well as the increased use of teleconferencing and videoconferencing where possible to slash unnecessary travel.

They also made an interesting parting comment: "Trial results should be made publicly available, as the environmental consequences affect us all."  Read More & Comment...

An ounce of preemption

04/13/2007 10:36 AM |

Make that a Troy ounce.

According to the Wall Street Journal …

“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.”

A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.

As Dan Troy has written:

“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.”

“FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.”

Amen.

It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.  Read More & Comment...

Arcoxia AdComm-edy of Errors

04/13/2007 08:58 AM |

What does the FDA do when a drug is demonstrably safe and efficacious compared to a placebo. It usually approves the drug. In the case of Merck's new COX-2, the AdCom reviewing the drug -- which now includes a lawyer suing Merck -- acknowledged that Arcoxia has the same risk profile as many other painkillers. But the FDA wanted evidence that it met some unmet medical need in a subpopulation.

How about people like me or millions of others who did well on Vioxx or Bextra that have neither?

Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.

According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.

In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.

Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.  Read More & Comment...

Rolling the Dice on Patient Safety

04/13/2007 08:29 AM |

Nevada legislators are once again rolling the dice on patient safety. This time it's not some half-baked and benighted scheme for cheap "Canadian" drugs, but rather an ill-considered plan to build a chinese wall around physician-prescribing data.

Here's the full news story:

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html

While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.

Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.

According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.” In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.  Read More & Comment...

Knock Knock. Who's There? Liberal Bloggers on Health Care.

04/13/2007 07:32 AM |

Liberal bloggers on health care who?

The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?

Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).

Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:

* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."

* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.

* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.

Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."

Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.

Here's a link to the complete report:

http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf

And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.

As far as I'm concerned -- the more the better.  Read More & Comment...