Weak End at Bernie's

06/02/2008 12:28 PM |

According to an article in livemint.com (the Wall Street Journal’s news partner in India), “For the first time ever, a consensus has evolved on creating global patent databases, monitoring drug prices and encouraging companies to differentially price their drugs, as a burgeoning health care bill pushes governments towards sourcing cheaper medicines.”

The initiative, part of a draft agreement adopted by all the countries in the World Health Assembly in Geneva recently, has been “cheered by public health advocates and makers of generic or off-patent drugs.” The assembly is an apex group of member nations at the World Health Organization or WHO.

The health assembly has, in its draft, also asked member nations to “encourage pharmaceutical companies and other health-related industries to consider policies, including differential pricing” to promote availability of affordable drugs and consider “development of policies to monitor (drug) pricing.”

The concept of differential pricing has been kicking around for some time with some success. Now, together with an up-to-date patent database, we should expect to see more of it. Most people think this is a good idea.

Novartis India Ltd's managing director Ranjit Shahani, who was the president of Organization of Pharmaceutical Producers of India, a lobby of foreign-owned drug makers in India, called differential pricing “directionally positive” and ones that recognize people's varying paying capacity, though the implementation should be through a workable model.

But not everybody is happy.

The clause for “drug monitoring” has failed to impress those of the Jamie Love school of “prizes for patents.” “Monitoring prices is a good step but controlling prices would have been a better and stronger one,” said Kajal Bharadwaj, a lawyer specializing in drug access-related patent issues and added that the health assembly text “legitimizes and validates the public health hedges in government policies that countries like India, Thailand and Brazil have been sticking up for”.

Actually, that’s not true. Clearly Ms. Bharadwaj would like it to be true and so, in typical Big Lie fashion, she will simply keep saying it’s true. This is the same tactic Jamie Love uses when he tells people in Europe that legislation in the United States calling for prizes to replace patents is going to become the law of the land. (FYI – this bill was authored by Senator Bernie Sanders, the Socialist Senator from Ben & Jerry’s and has, as of this writing, zero co-sponsors.)

Here's the complete livemint article:

www.livemint.com/2008/06/01232744/Draft-WHO-pact-on-drugs-cheere.html

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"Page" Turner

06/02/2008 11:52 AM |

A few weeks ago I was on a panel with J. Rick Turner, Chairman of the Department of Clinical Research and Director of the Cardiac Education Center at the Campbell University School of Pharmacy.  And, as usual, the most interesting part of the conversation happened after the panel was over.

As we were gathering our papers and checking our blackberries, Dr. Turner mentioned that he had written a new book on the issue of “integrated cardiac safety.”  I asked him to send me an advance copy.  And he did.

They don’t call him “Page” Turner for nothing.

His new book, “Integrated Cardiac Safety:  Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Post Marketing Surveillance,” is a timely and important addition to the debate over drug safety and, equally important, safe use.

Consider the following brief excerpts:

“A drug’s development in the sense of improving its safety and/or effectiveness profiles does not stop at the point of marketing approval.  Data collected during the drug’s use in large patient populations can lead to meaningful improvements in the drug.  This term, lifecycle drug development, therefore emphasizes that it is vital to remain vigilant about the drug’s effects from the very beginning of the drug discovery phase throughout the entire time that the drug is on the market and hence available for prescription to patients, and it captures the spirit of this book very well.”

“So too does the term integrated cardiac safety.  A central tenet of this book is that it is beneficial to discuss the assessment methodologies used to collect information on cardiac safety at four stages of lifecycle drug development—drug discovery and design, nonclinical development, preapproval clinical development, and postmarketing surveillance—in one book, and to integrate this information to the greatest degree possible.” 

“Meta-analyses vary in the number of patients included since this is dependent on the numbers in the individual trials combined in the new analysis.  However, typical numbers are also in the thousands. However, it is fair to say that statistical methodology is currently less well developed in the case of epidemiology studies than it is for randomized controlled trials: this is not meant as a pejorative statement, simply a statement of the current state of affairs that will hopefully and very likely change as additional spotlights on and developments in the field of pharmacoepidemiology increase.”

“It should also be noted here that the term nonexperimental is not a pejorative one compared with the term experimental.  Piantadosi discussed two fundamental types of study design, experimental and nonexperimental.  In experimental studies participants receive random treatment allocation, and observations are made under conditions in which the influence of interest is controlled by the research scientists.   In nonexperimental studies the research scientist also collects observations but does not exert control over the influences of interest.  Nonexperimental studies are often called ‘observational studies,’ but this term is inaccurate: it does not definitively distinguish between nonexperimental studies and experimental studies, in which observations are also made.”

The book, due out in November of this year is must reading – especially for Steve Nissen.

  Read More & Comment...

Obama's Off-Label Nicorette Use

06/01/2008 02:12 AM |

It’s taken 20 years but Barack Obama has once and for all quit. Not Trinity United Church of Christ, but smoking, a habit he picked up around the same time he joined the controversial ministry.

To do so, he has been chewing Nicorette, the smoking cessation gum. And he’s been chewing it longer and in larger amounts than is on the label.

Is Obama’s off-label use bad or dangerous? According to the dictates of Tabloid Medicine, of course it is.

However, Tara-Parker Pope puts his Nicorette consumption in proper perspective:

“Mr. Obama has said he started using the nicotine gum Nicorette about nine months ago. That’s six months longer than the three months recommended on the gum package label. And Mr. Obama is not the only quitter who is still seeking a nicotine fix months after giving up cigarettes. A small percentage of the people who use nicotine replacement products like gums or lozenges end up hooked on a new habit, say doctors who specialize in smoking cessation…..”

However…

“The problem is not that people use it too much,'’ noted Lynn T. Kozlowski, interim dean of the school of public health and health professions at the University at Buffalo. “The greater problem is that they use it too little. People use it for a week, and then they are back smoking cigarettes.”

well.blogs.nytimes.com/2007/11/02/obamas-new-addiction/

Then there is the individual variation in nicotine dependence shaped by genetics. A paper entitled: "Single Nucleotide Polymorphisms, Clinical Trials, and Tobacco Research: The Search for the Smoking Gun," explored the associations between genetic variations, nicotine usage, and the potential effects on smoking cessation techniques according to a press release from the American Society of Clinical Oncology.

This explains differences in Nicorette uses and variations in response to Chantix.

Someone might want to send that paper to Senator Grassley and Alicia Mundy of the WSJ both of whom seem eager to blame side effects of Chantix on a FDA-Pfizer coverup instead of “genetic variations at the receptor level, the drug metabolism level, or both.”

Read ASCO Article

That would be intellectually honest  Read More & Comment...

Mundy Morning Quarterbacking About Pharma At the WSJ

05/30/2008 09:52 PM |

  Read More & Comment...

Old News is Good News

05/30/2008 05:51 PM |

Samuel Johnson said that “the future is purchased by the present.”  And that’s as good a place to start as any in a discussion of the impact of direct-to-consumer advertising on the elderly.

According to recent polls, older Americans are more distrustful of the pharma industry and the FDA than the general population—and even more so in the wake of the current debate over drug safety.

Seniors want safe drugs—and rightfully so—but why are they more negative than other groups of Americans? I believe it is because throughout the significant majority of their lives, their only information about the medications they took came from a single source—their doctors. And the only information offered was how to imbibe the pill (with water, with food, minus alcohol, and the occasional caveat against operating heavy machinery). There was no doctor/patient discussion and there was certainly no public conversation.

That was the environment in which today’s senior citizens were born, grew into adulthood, married, raised children and grew grayer.

It was an environment where doctors were gatekeepers and the gate was kept tightly padlocked and second opinions were considered an affront to Marcus Welby, MD.

According to Juvenal, “All wish to possess knowledge, but few, comparatively speaking, are willing to pay the price.” Today we must face up to that dilemma.

Like it or not, America’s senior citizens are 21st century empowered healthcare consumers. Today, the “learned intermediary” has been replaced by the Internet, the patient is the purchaser, and Dr. Welby is a vendor. Managed care directs, “serious and life-threatening” diseases have morphed from polio and diphtheria to cancer, AIDS and Alzheimer’s Disease. There really shouldn’t be any wonder why older Americans—indeed, most Americans—are frightened. The entire healthcare paradigm has changed.

Woody Allen said that “Change is inevitable – except from vending machines.  Management guru W. Edwards Deming said that “Change is not required.  Survival is not mandatory.”

Change is frightening. In the 21st century, we must all be pharmacenti.  And that includes older Americans.

The Centers for Disease Control and Prevention National Health and Nutrition Examination Survey found that nearly one-third of people age 65 or older whom the survey found to have high cholesterol measurements said they had not before been told by a physician or other health professional that they had high cholesterol. Projected nationally, this percentage translates into about 2.1 million people who may have had high cholesterol without knowing it.”

 

Evidence is emerging that large numbers of elderly patients underuse needed medical care. According to a 2004 Health Affairs study that examined the “growing philosophical conflict over the abundance and inequities that characterize the U.S. health care system,” there is evidence of significant underuse of prescription drugs. The preponderance of published medical literature and clinical guidelines, according to the article, compels the expansion of pharmaceutical use among Americans.

 

This view is supported by a landmark RAND Health study published in The New England Journal of Medicine in June 2003, which found that prescription medications were underused in the treatment of seven conditions that clearly involve secondary prevention, including asthma, cerebro-vascular disease, congestive heart failure, diabetes, hypertension, and high cholesterol. These conditions produce many avoidable deaths, along with costly avoidable emergency room visits, hospitalizations, and nursing home admissions. Three of these conditions— diabetes, hypertension, and high cholesterol are now screened for under the new preventive services benefits now covered by Medicare.

 

Healthcare education and health literacy for older Americans is essential for both saving lives and saving our health care system.  And the best way to do both is to get older Americans to talk with their doctors – precisely the proven result of pharmaceutical direct-to-consumer advertising.

 

Health care information is the consumer’s Rosetta Stone – but older Americans shouldn’t need a Rosetta Stone to understand the avalanche of health care information that is available to them today. 

 

Dr. Ruth Day of Duke University speaks about the issue of “Cognitive inaccessibility” -- that health care information is disseminated in a way that is not only not understood by consumers but, worse, is misunderstood leading to unintended consequences. She reckons that only 20% of the information put out by FDA is properly comprehended. Her suggestion (among others) is that FDA initially focus on communicating better with health care providers.

 

When it comes to DTC advertising there is another type of cognitive issue – cognitive dissonance, specifically when it comes to information presented either via fair balance and adequate provision in television commercials, or the brief summary in print advertising.  And you know what they say, the brief summary is like the Holy Roman Empire – it is neither brief nor a summary.

 

In FDA’s 1999 study, 56% of people who saw a DTC print ad said that they read the brief summary “not at all” or “a little.”  In the 2002 study that number jumped to 73% -- a 17% increase.  During that same three-year span, those saying they read “Almost all” or “All” fell from 26% to 16%.

In 1999 3% said they weren’t aware that there even was a brief summary.  In 2002, that dropped a full decimal place to 0.3%.  In other words, more people know the brief summary is there, and fewer people are reading it. More information often results in less comprehension and, even worse, less interest.  When it comes to older Americans this is a crucial issue that must be addressed by academics, the pharmaceutical industry, and the FDA.  “In compliance” and “user-friendly” must not be mutually exclusive terms for anyone – least of all older Americans.

Consider the question posed by T.S. Eliot who asked,

"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information?”

  Read More & Comment...

Critical Path for Jackpot Justice

05/30/2008 05:11 PM |

Call me naïve – but I still find this revolting.

According to many reports (this one from the Newark Star-Ledger), “A controversy over the cholesterol-fighting medicine Vytorin has spawned at least 33 lawsuits by consumers who are angry over the way Merck and Schering-Plough promoted the medicine to lower low-density lipoprotein.”

"By failing to timely release the results of the Enhance trial, which demonstrates that Zetia does not reduce or slow the build-up of arterial plaque, defendants reaped billions of dollars in profits that they otherwise would not have obtained," the lawsuits allege.

In addition, the plaintiffs claim they might not have purchased the pricey drugs if they had known they didn't work any better than the generic form of Zocor, which is much less expensive.

Here’s a link to the complete article:

http://www.nj.com/business/ledger/index.ssf?/base/business-1/1212122169217600.xml&coll=1

In a statement, Merck said it would "vigorously defend" itself against the allegations.

And “amen” to that.

  Read More & Comment...

Mark Thornton Update

05/29/2008 08:19 PM |

Mark is not just a friend...he is a CMPI board member who, along with other patient advocates who serve as board members -- Suzanne Pattee of the Cystic Fibrosis Foundation and Dennis Johnson of the Children's Health Fund --  make -- sure that what we do is patient-centered and focused on access to health care and better medicines...  Read More & Comment...

More Healthcare for Dummies

05/29/2008 08:17 PM |

Per “Healthcare for Dummies,” (http://www.drugwonks.com/blog/healthcare_for_dummies/), I just received an “off the record” comment from a health care reporter I consider to be among the smartest and savviest around.  He writes:

 "The responsibility lies with editors. If editors rewarded careful, nuanced reporting and rejected crap, reporters would respond. For example, (name deleted) is smart and hardworking and capable of writing thoughtful stories. She also knows that a leak from a defense lawyer of a "gotcha" memo will land her story on the front page, while a careful analysis will go on page C400. And (second name withheld) knows that quotes from Sid  'I always cry' Wolfe will be accepted, so he doesn't have to work hard  to seek other voices. A good editor would push for better sources."

  Read More & Comment...

Endpointing the Finger

05/29/2008 08:15 PM |

An important op-ed from today's Wall Street Journal, penned by our friend Mark Thornton.

By MARK THORNTON

The news did not make it to the front pages, but on Feb. 28 a powerful member of the U.S. Senate launched an attack on the Food and Drug Administration, the drug companies and the desperate cancer patients they treat.

Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee, requested that the Government Accountability Office launch an inquiry into whether the FDA behaved appropriately in granting the "accelerated approval" of Avastin, a drug for treating women with metastatic breast cancer. Mr. Grassley's action will have a catastrophic effect on America's ability to develop new drugs.

At issue is the concept of "surrogate endpoints" and the FDA's "accelerated approval" regulations. In the 1980s, at the height of the AIDS epidemic, AIDS activists were livid at the slow pace of development of new drugs to fight HIV. They lobbied heavily for changes in the law to allow an expedited pathway for the approval of new drugs for any disease deemed serious or life-threatening. The historic results were new laws and regulations that created an accelerated approval mechanism by which a drug could be allowed on the market if it showed early evidence of an effect on a surrogate endpoint. For cancer, examples of surrogate endpoints are tumor shrinkage or a delay in the disease's progression.

This kind of measurement – as opposed to an assessment of a drug's impact on a patient's overall survival – has dramatically increased the pace of cancer clinical trials. It also has won near-universal acceptance within the cancer community. The FDA does require follow-on studies to assure that a surrogate finding shows clinical benefit. But if all cancer clinical trials were required to show a survival benefit from the get-go, progress in cancer-drug development would slow to an absolute crawl.

Enter Mr. Grassley. It seems not a week goes by without him making a public accusation of evil doings within the drug industry or the FDA. Yes, Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA. But he and his staff should have kept their eyes on the ball. In the case of Avastin, the senator implied in his GAO request that something sinister occurred during the FDA's premarket deliberations, and that surrogate endpoints were the new bogeyman. Nothing could be further from the truth.

In February, the FDA approved Avastin despite a 5-4 vote by its Oncology Drugs Advisory Committee (ODAC) not to recommend approval. Meetings of this advisory committee address the most vexing issues that exist in cancer-drug development. The advice is usually helpful but never binding. Everyone who works at the FDA knows that the public only sees a fraction of what FDA insiders consider when they make their final decisions on products.

In the case of Avastin, additional data emerged late in the review process, after the ODAC meeting, that strongly supported accelerated approval. It became clear that Avastin had an enormous impact on the surrogate endpoint known as "progression-free survival." PFS is such a powerful measure that it is actually used as the basis for full approval in many cancer indications.

As part of the accelerated approval letter, the FDA also placed some of the most stringent postmarketing requirements in history for the drug's sponsor to gain full approval. No standards were lowered, and many women may now live much longer without their disease progressing.

The damage done by Mr. Grassley's decision to make an issue of this decision cannot be understated. Having served at the FDA during the Congressional hearings over the Imclone/Martha Stewart insider trading scandal, I can attest to how an action like this GAO inquiry will resonate within the halls of FDA. An extremely cautious and protective bureaucracy will respond to such intimidation by being even more protective.

The senator is demanding a full-scale review of each and every product ever approved, and is asking for a rejudgment by GAO "to ensure that drugs approved on surrogate endpoints are both safe and effective."

You can bet these bully tactics will have an effect. Look for greater demands by the FDA for cancer programs to not use the accelerated approval pathway. Just a few weeks ago, Medarex Inc. announced that the FDA will renege on a commitment to grant accelerated approval of a new product for skin cancer if its clinical trial showed benefit using the PFS endpoint. The FDA ordered a change toward the much stricter endpoint of overall survival, adding years to the time it will take to evaluate the drug's efficacy.

U.S. cancer-drug development stands on a precipice overlooking a new dark age in which each new product's development is longer and costlier than the last. Companies may decide it is not financially viable to even bother developing new drugs, and the pipeline for new products to treat cancer could slow even more. Mr. Grassley's legacy could be thousands of additional cancer deaths.

Advocates for all patients affected by Mr. Grassley's antidrug company demagoguery – including cancer patients, Alzheimer's patients, AIDS patients – must make their voices heard.

Dr. Thornton is a former medical officer in the Office of Oncology Products at the Food and Drug Administration. He volunteers as president of the Sarcoma Foundation of America.

  Read More & Comment...

Conflict of Interest Police and the Academic Boycott of Israel are Birds of a Feather

05/29/2008 08:12 PM |

Recently an organization representing major academic research institutions introduced a resolution proposing that such entities consider the moral and political implications of educational links with pharmaceutical and to discuss such association with individuals and institutions concerned, including researchers in industry with whom they are collaborating."  It also called for a moratorium on research  with industry because industry has damaged the fabric of academic medicine over the past 40 years.

Actually, the ban and the resolution came from the UK University and College Union and it applied to Israel, not Big Pharma. I have just returned from Israel and spoke to several of the world's leading researchers in their fields to -- who receive no pharma funding -- and have heard of how their research has been shunned, ignored, passed over by other academics in a corrupt, biased, small minded peer-review process.  Being Jewish -- especially if you apply for funding in Europe -- does not help.  So much for purifying academic medicine by driving pharma out!! 

But I digress -- sort of.   But the presumption of damage and the guilt by association -- and the unsubstantiated nature of it all fueled by a leftist hatred that is unbalanced and blinds the conflict of interest kapos to other forms of conflict that are more pervasive and corrupt that conveniently reward their cronies. Mitchell Cohen notes in Dissent regarding "Anti-Semitism and The Left That Doesn't Learn"

If you judge a Jewish state by standards that you apply to no one else; if your neck veins bulge when you denounce Zionists but you’ve done no more than cluck “well, yes, very bad about Darfur”;

if there is nothing Hamas can do that you won’t blame ‘in the final analysis’ on Israelis; you probably are an anti-Semite.

Similarly

if you judge pharmaceutical companies or those who receive pharma funding to support their research no matter how transparent or for whatever research that you apply to no one else; if your neck veins bulge when you denounce Big Pharma but you've done no more than tsk "well, yes, terrible about PBM drug switching or peer-review panels stacked with cronies";

if there is no medicine you can't write about without claiming it wasn't developed by pharma or is not really effective;

if your anger at drug companies doesn't sound any different from the unthinking American conservatives attacks towards those who support universal health care out of a true sense of compassion? 

Then you are simply part of the group seeking to stifle and suppress and eliminate debate out of hate.  As Labor MP Dennis McShane noted: “there is an anti-Jewish discourse, a mood and tone whenever Jews are discussed, whether in the media, at universities, among the liberal media elite or at dinner parties of modish London. To express any support for Israel or any feeling for the right of a Jewish state to exist produces denunciation, even contempt.”

The same tonality runs through the anti-pharma, conflict of interest blogs.  

Birds of a feather.

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Healthcare for Dummies

05/29/2008 08:07 PM |

"Too often medical reporters haven't been trained in the basics of understanding medical research and evidence-based medicine." 

So says Gavin Yamey, senior editor at PLoS Medicine.

This isn't to say there aren't some really terrific, highly aware ones out there as well -- there most certainly are. But they are in the minority.  If you agree with Gavin Yamey, the question then becomes, what's the best way to get reporters trained and who should do the training?

Should it be industry?  "Advocates?"  Academics?  Government officials?  Medical organizations?  Disease organizations?  Patient organizations?  Should there be a mandatory "health care for dummies" class in journalism schools?  The current practice, it seems, is on-the-job training.

The results (often inaccurate, sometimes slanted) are not a service to the health care information consumer (reader, viewer, listener). And there ain't no CME.

What's to be done?  Clearly one path is for reporters to reach out to various sources for background -- and to make sure those sources are diverse -- thus guaranteeing a variety of opinions and avoiding undue, single-source bias.

In fact, now that I think of it, that's probably a good idea for all health care reporters -- even those with well-known and well-read bylines.

  Read More & Comment...

What will the folks at Slate say!

05/28/2008 07:57 PM |

A recent study published in Health Affairs found that a prior authorization policy implemented by Maine Medicaid to restrict use of atypical antipsychotics (AAs) led to discontinuities in treatment among patients with schizophrenia. Researchers found that patients initiating treatment with AAs after the policy was instituted in Maine were 29% more likely to have treatment discontinuities than patients initiating treatment with AAs before the policy took effect.

In addition, spending only slightly decreased after policy implementation, suggesting minimal total cost savings at the end of the eight month policy period when compared to New Hampshire. The researchers report that prior authorization policies for antipsychotics and other mental health medicines may be problematic due to increases in treatment discontinuation, which often lead to psychotic episodes, hospitalizations, or other hazardous clinical and economic outcomes.

  Read More & Comment...

FDA Rocks the Cradle

05/28/2008 07:52 PM |

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit,” said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. “This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women.” 

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.  

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

--The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: “Human data indicate that (name of drug) increases the risk of cardiac abnormalities.” This would be followed by a summary of the most important data on the drug’s effects.

--Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.

--The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

  Read More & Comment...

Punxsutawney Pill

05/28/2008 07:48 PM |

Interesting story in the New York Times about a company that's producing placebos for kids.

According to the article: "Jennifer Buettner was taking care of her young niece when the idea struck her. The child had a nagging case of hypochondria, and Ms. Buettner’s mother-in-law, a nurse, instructed her to give the girl a Motrin tablet. She told me it was the most benign thing I could give, Ms. Buettner said. I thought, why give her any drug? Why not give her a placebo? Skip to next paragraph

Studies have repeatedly shown that placebos can produce improvements for many problems like depression, pain and high blood pressure, and Ms. Buettner reasoned that she could harness the placebo effect to help her niece. She sent her husband to the drugstore to buy placebo pills. When he came back empty handed, she said, It was one of those ‘aha!’ moments when everything just clicks.

With the help of her husband, Dennis, she founded a placebo company, and, without a hint of irony, named it Efficacy Brands. Its chewable, cherry-flavored dextrose tablets, Obecalp, for placebo spelled backward, goes on sale on June 1 at the Efficacy Brands Web site. Bottles of 50 tablets will sell for $5.95. The Buettners have plans for a liquid version, too."

Sounds good? Maybe not. Consider the comments of Dr. Howard Brody, a medical ethicist and family physician at the University of Texas Medical Branch at Galveston. “Placebos are unpredictable. Each and every time you give a placebo you see a dramatic response among some people and no response in others.”

“The idea that we can use a placebo as a general treatment method,” Dr. Brody said, “strikes me as inappropriate.”

Here’s a link to the complete article:

And here’s my take – will products like Obecap teach children that there’s a pill for every problem? Is that a health care message that we want to teach our children? It also reinforces the general mindset that leads to parents demanding antibiotics for ear-aches. Not the way to go. We need to teach our children wellness.

  Read More & Comment...

Love's Laborers Lost

05/27/2008 06:02 PM |

Some good news from the just completed World Health Assembly -- for the first time at the ministerial level, there was an extended discussion on counterfeit medicines. And the really good news is that a majority of countries are aligning for strong concerted action. (China laid low.)

Not Brazil. Their main concern was related to the definition of counterfeits because of its intellectual property rights (IPR) implications. One of Brazil’s hang-ups centered on the potential inclusion of "substandard" medicines” in the overall definition of “counterfeits” -- which Brazil sees as a code word for unauthorized generics and similares.

And not India. According to Gopa Kumar, research officer at the Centre for Trade and Development, “Counterfeiting is an issue of trademark violation and has no bearing on public health.”

Yep – that’s a direct quote, Check it out here:

http://www.livemint.com/2008/05/23004023/India-fears-generic-drugs-may.html

The only thing this absurd rhetoric from Brazil and India puts into context is the pretzel logic gyrations of Jamie Love and his Sci-Fi obsession over the “definition” of counterfeits.

For more on this, see “Putting Lipstick on a Blister Pack” here:
http://www.drugwonks.com/blog/putting_lipstick_on_a_blister_pack/

This time the clock was on the side of Brazil and India because there was insufficient time to convene a drafting group to resolve the resolution. But the resolution (proposed by Nigeria and others), to aggressively address the problem – and define counterfeiting for what it is – criminal international health care terrorism, is on the table for discussion at the Executive Board meeting in January. That’s concrete progress.

And remember the words of Hubert Humphrey:

“Things are not only what they are. They are, in very important respects, what they seem to be.”  Read More & Comment...

Worth a Look

05/27/2008 06:01 PM |

Trevor Butterworth's take on straw man attacks against CMPI -- and Peter Pitts/Fred Goodwin in particular --  in the wake of The Infinite Mind story....

www.stats.org/stories/2008/prozac_wars_may12_08.html  Read More & Comment...

Disturbing Behavior

05/27/2008 06:00 PM |

Peter (mostly) and I (less so) have had a taste of what others like Paul Offit and Fred Goodwin have faced in advocating the use of vaccines and antidepressants respectively and what scientists who engage in animal research endure regularly: abuse from out-of-control and obsessive hatemongers who receive succor and support -- or at the very least -- uncritical coverage by the media as the fail to engage on the substance of issues and instead attack motives and indulge in misleading and distorted use of selective reporting. Our willingness to challenge those who have been responsible for scaring people from using antidepressants have diverted attention away from the consequences of a decrease in use with blind fury, moving from antidepressants to antipsychotics without regard to the original argument or point, harping instead on funding sources with an obsession that reveals a lack of intellectual bandwidth and genuine hatred that borders on the personal.

The blogs that have allowed these posting -- unfiltered -- know better and bear a responsibility for allowing the attacks and vitriol to become so unhinged and personal. We recommend that you review some of the post as www.pharmalot.com
or www.pharmagiles.com   that in particular mocks my use of medications and that of my daughter's to see what we happily deal with....

These are sad, hateful people. The problem is they often reflect and influence the thinking of people like Brownlee and Lenzer who are considered mainstream.

We at CMPI are simply trying to insure that people get the right medicine at the right time. No more, no less.  Read More & Comment...

Avastin continued

05/27/2008 05:59 PM |

Regarding my previous post on Avastin naysayers someone commented: "Brain...Colon....time for you to learn the difference! Seriously though. Maggie's point, while possibly as overstated as your own point, is noted. Progression-free survival is a surrogate endpoint, and without some other demonstration of benefit (improved overall survival or improvement in a verified measure of quality of life), it is not very helpful for those trying to make some hard decisions regarding a difficult disease. Since the FDA has no real teeth to enforce post-approval study committments, if the company gets approval using "low-bar" standards, there is never any other bar that gets used."

I know the difference of course.  And as far as progression free survival not being helpful or not being a quality of life measure..many cancer patients and physicians would beg to differ.   If the commenter regards as a low bar standard then he can apply to himself, his loved ones and his friends.  But don't impose it on me and my family.   Improved survival overall in a disease that is as genetically diverse in origin and progression as cancer is total nonsense, a dodge for denying access and it is the ultimate low bar standard.  It is death sentence for sure.   Read More & Comment...

CMPI in Israel

05/27/2008 05:58 PM |

“The Second Health Care Technological Innovation Program-
From Idea to Commercialization”

An Executive Program for Biotechnology and Medical Device Entrepreneurs and Managers.

The Faculty of Management of Tel-Aviv University, the Israel Life Science Industry Organization (ILSI), The Center for Medicine in the Public Interest and International Institute for Biotechnology Entrepreneurship (a non-profit global contribution by Burrill & Company) are now holding the second program “Health Care Technological Innovation - From Idea to Commercialization.”

This program focuses on the critical elements in the formation, launch, and strategic and operational management of health-related technologies, with a particular focus on companies working in medicinal biotechnology, enabling technologies for life-science research, and medical devices used in human diagnosis and treatment.

We have had many excellent presentations focusing the value-driven reimbursement, personalized medicine as a platform for comparative effectiveness and the role of the Critical Path as a framework for demonstrating risks and benefits of products over the life of a product.

At the same time, Peter Pitts is featured in The Journal of Biolaw and Business Special Commemorative Edition published in honor of Israel's 60th anniversary.  His article: "FDA and the Critical Path to 21st Century Medicine" is based on his presentation at the first CMPI sponsored seminar for Israeli life science startups in November 2007.

For the abstract and more info on The Journal go to www.biolawbusiness.com

PS  I am also in Israel to see my son receive his beret after completing basic training in the IDF.

Here's the photo.

  Read More & Comment...

18 Across

05/27/2008 05:57 PM |

The 18-across clue in today's New York Times crossword puzzle reads, "Memorable Marathon Man query."  The correct answer, of course, is "Is it Safe?"

Everyone, it seems (including my hero, Will Shortz) wants to talk about safety.

And nobody more so (or more appropriately so) than the FDA.  Remember -- it was Milton Friedman who said that the FDA was "obsessed with safety."  And while Professor Friedman didn't mean it as a badge of honor -- it was taken as such by the 10,000 dedicated public servants at the agency.

But, unfortunately, safety seems only to "sell" when there's a tabloid quality to it.  Ask yourself this:  What do Vioxx and Avandia and Heparin all have in common?  Answer:  Page One coverage.

In today's New York Times, reporting on the FDA's new "Sentinel" program appears on Page A18 -- on a slow news day.

It's just another example of tabloid journalism trumping solid reporting.  And, for the record, the article in the New York Times by Gardiner Harris is a solid piece of reporting.  Have a look :

www.nytimes.com/2008/05/23/washington/23fda.html

Tabloid is easy.  Quality is hard.  Read More & Comment...