Latest Drugwonks' Blog
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.
"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.
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.
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.
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?
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.
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.”
www.stats.org/stories/2008/prozac_wars_may12_08.html
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.
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.
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.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
