Pharmalot… Pharmalittle… The Weekend Nears

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lawn-mower1And so another working week will soon draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes yardwork, hanging with assorted short people and another installment in the ‘Let’s-see-them-before-they-die‘ concert series. And you? Anything special in the pipeline? How about curling up with a good e-book? Or a dinner with a favorite someone? Or maybe just a walk in the park? Whatever you do, have a great time and be safe. See you soon…

FDA Approves J&J HIV Med For Combo Use (Reuters)

EU OKs Bloodthinner From Pfizer And Bristol (Associated Press)

EMA Approves Glaxo And Human Genome’s Benlysta For Lupus (Reuters)

Pfizer Truck Robbed On Way To CVS (Securing Pharma)

AstraZeneca To Eliminate 135 Jobs In Massachusetts (Boston Business Journal)

Takeda Destroyed Shareholder Value More Than Any Drugmaker (Bloomberg News)

FDA Panel Calls For New Trial Of Abbott Triplix Pill (Associated Press)

Verizon And Medco Launch App For Finding Cheap Meds (Computerworld)

AstraZeneca Is Eyeing Another US Acquistion? (The Telegraph)

Sandoz Files For Generic Verision Of Shire Vyvanse ADHD Pill (Pharma Times)

Targeted Cancer Therapies Gaining Momentum (Reuters)

EDITOR’S NOTE: Please check this post for updates throughout the morning

lawn mower pic thx to miggslives on flickr

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  1. Just think of all the time and money that could be saved if the drugs we already have were used more wisely, instead of concocting all these new and horrendously expensive targeted drugs and relying on maintenance therapy?

    Many conventional chemotherapy drugs, in addition to killing tumor cells, also fight angiogenesis. The anti-angiogenic effects of therapy are masked and marginalized by the way it is usually administered. There are generally long breaks between drug administration that are necessary to allow the patient to recover from the harmful side effects of treatment.

    When administering these drugs, the endothelial cells (involved in angiogenesis) are the first in the tumor to undergo cell death (apoptosis). However, this anti-angiogenic effect does not translate into a significant therapeutic benefit because the damage to the vasculature of the tumor can be largely repaired during the long rest and recovery periods between successive cycles of therapy.

    The more frequent, lower-dose therapy can have an impressive anti-angiogenic and anti-tumor effects. Blood vessel cells are less likely than tumor cells to become resistant to chemotherapy, so if cancer cells become drug resistant, these medicines should still be able to shrink tumors by destroying their blood supply.

    The main targets of dose-dense chemotherapy are proliferating tumor cells. The main targets of low-dose chemotherapy are the endothelial cells of the growing vasculature of a tumor. In other words, chemotherapeutics can be used as anti-angiogenic agents.

    But this type of protocol willl never make the pharmaceutical companies gobs of money!

  2. You make a good clinical case then you take a vicarious jab at the industry that has made it possible to live longer and healthier. You know, you shouldn’t believe what Peter Rost says. He is worse than the companies he accuses. He has made over $10MM on just one case and I saw him in action he did not do anything to stop anything. He is a worthless slug. Actually I know he reads these comments and assists Silverman in these columns that’s why this column has such an anti industry slant to it.

  3. Greg, the NIH does trials all the time, not to mention all the investigator-sponsored trials in academia. I think if it were as simple as you make it out to be, somebody would have demonstrated this in the 30 to 40 years most of these drugs have been available.

  4. LOL! And Larry Norton, deputy physician-in-chief for breast cancer at MSK argued that giving the same total dose of chemotherapy over a shorter period of time would boost the cure rate by limiting the time tumors could regrow between treatment, got a skeptical reaction and took decades before he was able to prove his theory? I’m sure they thought too, if it were as simple as he made it out to be, somebody would have demonstrated this in the 30 to 40 years most of these drugs have been available. Right!

    And yes, an industry that has made it possible to live longer and healtheir? Drug companies develop drugs aimed at the widest possible population, that takes place in a culture of maximum possible sales for maximum possible profit, although the fact is that most drugs don’t work for most people. Few people realize just how poorly they perform in real life, according to a senior executive with one of the biggest drug companies in the world. And many people die from them!

  5. Well Greg, I’m not familiar with Dr. Norton’s paper but the optimal dosing of chemotherapeutic agents is quite extensively studied both pre- and post-marketing, both by the innovator company and academic scientists. For example, a Clinicaltrials.gov search for non-industry sponsored trials of taxol gives 914 hits:

    http://clinicaltrials.gov/ct2/results?term=taxol&recr=&rslt=&type=&cond=&intr=&outc=&lead=&spons=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&fund=0&fund=1&fund=3&rcv_s=&rcv_e=&lup_s=&lup_e=

    And yes, the industry has in my opinion made it possible to live longer and healthier. Ask anyone with multiple sclerosis, rheumatoid arthritis, hepatitis C, HIV, CML, AML, HER2+ breast cancer, Parkinson’s disease, Pompe disease, age-releated macular degeneration, or who has ever had a bacterial infection.

    I think we all find the idea of searching for new drugs as a for profit activity a little uncomfortable, but so far nobody seems to want to have their taxes raised so that the government can do it. I suppose if you find the whole system so objectionable that you want to opt out, you can do so.

    When I started my new job one of the insurance options I was offered was a policy that covers only generic drugs. The cost savings was not that substantial, in line with CMS figures that show that only 10% of national healthcare expenditures are pharmaceutcal-related.

    Drugs do kill people, but so does surgery (and for that matter, automobiles). I think they both have their place when the need is such that the cost benefit ratio is favorable.

  6. I have a feeling that the Pfizer heisters were going after the Vitamin V, but they got a bad “tip”.

  7. Dear ‘John,’

    Thanks for your note, but just to set the record straight - no one assists me in assembling Pharmalot. I have many sources in the industry and among those who deal with pharma or follow pharma. But the responsibility is mine alone. I have no idea how you came to this assumption, but it is incorrect, if imaginative.

    As to your assertion of an ‘anti-industry slant,’ you may have missed my explanations of the past, so… The industry has been undergoing enormous change, which produces tension. And so I seek stories that illustrate and explain the tension, whether this involves litigation, legislation or policies regarding marketing, R&D, strategic directions and pricing, among other things.

    Granted, drugmakers sometimes find themselves in unflattering circumstances. But journalists tracks those episodes, they don’t create them. More important, any improvement in business practices that results from shining a light on systemic problems presumably would benefit all concerned - from employees to patients to shareholders.

    Finally, I live and work in New Jersey, and so the ongoing consolidation affects employment, housing and tax revenues, all of which trickles back my way. I also have family and friends in pharma. My kids have friends whose parents are in pharma. I hear the stories. I see the concerns. I track their challenges. I am reminded regularly how the tension affects many people in many ways. Consequently, I have nothing to gain should pharma meet an untimely demise.

    Hope this helps,
    ed

  8. I WOULD LIKE TO SPEAK WITH WHOM EVER PUBLISHED THE J&J STORY, I THINK IT IS NOT RIGHT TO CONTINUE PUBLISHING SOMETHING ON LINE THAT IS NOT TRUE AND HURTS PEOPLE, FREEDOM OF THE PRESS CAN BE CARRIED TO FAR, AND WITHOUT MORALS WHEN SUCH STORIES DESTROY PEOPLE WHO ARE THE INOCENT VICTIMS OF A CURCUMSTANCE,AND DO NOT REALLY HAVE THE POWER THAT IS PORTAYED IN A STORY.

    IT IS UNCONSCIONABLE TO ME TO NOT GET ALL SIDES OF A STORY AND THEN CONTINUE YEARS LATER TO ADVERTISE THIS SAME STORY FOR YEARS ON LINE.AS THOUGH IT WAS TRUE.

  9. The Journal of Bioethical Inquiry had already done a expose in which many drug companies use their marketing muscle to mislead physicians and consumers about the safety and effectiveness of their products. While this is nothing new, the Journal article showed how widespread this practice is and how unreliable medical research really is.

    Our medical knowledge grows not in the direction that best improves our health but toward corporate profits, the way a plant grows toward sunlight. The vast majority of clinical trials are commercially funded raising the financial stakes so high that there is mounting evidence of individual scientists (like chemists) and corporations manipulating their findings.

    A 2003 report in the Journal of the American Medical Association found that clinical studies funded by drug companies are three times more likely to conclude that the sponsor’s drug is the treatment of choice, compared to studies of the same drug that were not commercially funded.

    The disturbing conclusion is that most of the evidence in what doctors believe to be evidence-based medicine is nothing more that infomercial masquerading as dispassionate science.

  10. Other John, taxpayers have long paid for research/experts. Really you can’t just op out of from the felonious companies even though some of the top paid experts have bilked millions from the taxpayers while printing false information about drugs. For an even bigger slap in the face, most highly respected experts are also paid by big pharma.

    The CDC has spread taxpayers wealth around. A top expert who has been charged with wire fraud and of money laundering enjoyed his money he received from us taxpayers. Yet no high profile news about him except to convince parents they are crazy for not following these crooks off a cliff. Dr. Poul Thorsen enjoyed the millions we the people gave him for research. His jail time will never make up for the lies that are told in his honor.

  11. From my point of view, the system, for all its problems, has produced a lot of good. When I was a kid, my brother was diagnosed with Hodgkin’s disease, and I was told he would not live to see 18 years. He’s 48 today and the cure rate for Hodgkin’s is 95%. AIDS is a chronic manageable disease. The cure rate for HCV has gone from 5% to 70%. And the treatment of a much longer list of diseases like breast cancer and MS, has improved dramatically. One doesn’t need to rely on published results to see this, talk to some patients or individual doctors (if you can find one you trust) instead.

    Just as a fact check, about 3/5’s of clincal trials are funded by non-industry sources according to clinicaltrials.gov.

    The innuendo about chemists fudging data was pointlessly unkind. And not helpuful to your point when judging others for presumed bias.

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