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Wyeth Pipeline Springs Another Leak

    • This is another supporting evidence: Its not that FDA has become conservative in approving drugs rather after Vioxx, Bextra etc, NOW they are doing their job in a more effective manner. Companies like Wyeth, Pfizer and even JNJ, try to submit new drug applications to the FDA, knowing fully well their deficiencies in advance,hoping that FDA might not notice the loopholes and approve them. Hope the FDA and other regulatory agencies are alert when they get these applications from companies like Wyeth, Pfizer & JNJ. Of course there are examples of small companies doing the same trick: recenet examples, GPC biotech & Dendreon. Only when the FDA briefing documents released, we were able to see the major loopholes in their applications. Good Job FDA!!!

    • Are you kidding me? Not only can't you spell but you have absolutely no clue the business, investment, and high risks drug companies expose themselves in order to bring a product to the market. Bringing a medication to market is the riskiest and most scrutinized business to have your hands in. No, I'm no longer in the business after 10 years but I do have an idea the difficulties these companies face every day. Think about it idiot- anytime you ingest any foreign body, besides water, into your system you are going to have side effects. Even TUMS and ginseng come with side effects. Do you know how many dollars it takes for 1 drug to even make it to the market? $600-$800 million as of a couple years ago, which probably today has escalated. Do you know how many out of 12 drugs being developed even make it your Wal-Mart shelves? 1 out of 12. After the drug is on the market every pharma company takes the revenues for further research and development for new breakthroughs. The FDA is strictest government body in the world because of recent recalls. Like the FDA, hospitals, and doctor's offices, pharmaceuticals is a for profit business. But nevermind the positive effects cholesterol drugs, life-saving heart medications, anti-seizure, high blood pressure, child and adult diabetes, anti-blood clots, ONCOLOGY, VACCINATIONS, yada, yada, yada, must I go on detailing the extremely important drugs these companies have developed? Why are people living longer? When Zelnorm was pulled off, do you know how many patients with IBS were screaming out this was the ONLY medication that worked for them and the benefits heavily outweighed the side effects? Check the IBS blogs and websites. Out of every healthcare dollar spent by consumers, how much goes towards the "high cost" of pharmaceuticals? $0.10. The other $0.90 goes towards your doctor visits, diagnostic testing such as MRIs & PET & CAT scans, surgery, obstetrics, etc. Get the drift? I'm tired of people who don't have an idea about the business side of pharmaceuticals believe Wyeth, Pfizer, JnJ and other pharma companies just pull a drug out of their hat everyday and try to throw a curveball past the FDA? Did you even know Pfizer is part of the Dow? Why don't you stop taking your Xenical and see how long you live.

    • Good job FDA!!!
      Its time that these companies do not submit drug applications to the FDA knowing fully well that there are safety concerns. PS: My previous post was removed ( Pfizer & JNJ are the other notorious companies who do this often-hoping that FDA approve unsafe drugs without a diligent review)

    • Seriously leave your trailer, go to Wal-Mart and clock in. You are late for work. Be careful you don't fall and break a hip because I'd hate for you to have to buy a JnJ hip replacement. Then fill your presciption for Lipitor because the free clinic doctor said you are fat!!

    • "I have a clue":
      You sound like one of the management teams at Wyeth. I or the public have no problem with truly innovative drugs but I do have a problem when companies like Wyeth (with all MDs, PhDs, clinical & regulatory etc) submits a drug which, upon review of the data, shows that it is no better than currently approved schizo drugs in the market.

    • I have a simple question after reviewing the previous comments: Why did Wyeth spend 600-800 millions (based on I have a clue comment) on a drug that probably indicated way back in phase II or IIb stage that it is no better than the currently approved schizo drugs?? So just because a company spends stupidly some extravagant money on developing a relatively less effective drug is that mean the FDA should approve? or the public should support big pharma's stupid research???? Is this the way research is done by the big pharma?? I am confused!

    • Actually just to bring a new compound to the Phase II or IIb stage takes $600 million--average total cost to bring a new compound to market today is $1 billion.

      The drugs currently on the market that treat schizophrenia have terrible side effects, so even a drug that is slightly less efficacious, but with a better tolerability profile is sometimes preferable.

    • Folks: you are arguing about peanuts. The FDA belong to that same organization that has no problem spending 100 billion a year in a war to hunt for a guy that isn't there. And more than half of you voted them in. Ha! Ha! Ha!

    • This is a tough position, companies can't really know how effective or the side effect profile until capital is spent on large phase 3 trials. No company wants to waste time and money. Everyone wants innovative breakthrough - remember Pfizer's HDL compound? OUCH! I hope for everyone's future health (our children's health) that companies are able to find innovative products that more effective, safer, or easier to tolerate.

    • Folks - 'I have a clue' has some very valid points that should not be ignored in the fingerpointing. it is very easy to say 'big bad pharma' and move on. It does cost a lot to produce a single new innovate drug which is safer - Recent estimates by some studies are between $1.2 - 1.7B; take as much as 12-15 yrs to bring to market and loose exclusivity within 2 yrs for more popular caterogies [e.g. Viagara, Lipitor....]. The folks working in Pharma are some of the smartest and most dedicated folks really trying to improve health and outcomes. But everyone seems to talk about only the cost of rising drugs as the biggest piece of the ~$2 Trillion healthcare spend in US alone, whereas it is only ~10%. Not to mention all the positive effects this industry has provided to people in extending not only the years of life, but also the quality of life. Every drug that one takes has side effects - the ultimate decision rests on addressing effectiveness over risk.

    • Pfizer's former CEO knew way back during early phase II that the HDL compound was no good. Lot of project team members were forced out for not being a team member when they voiced their opinions with supporting facts to their immediate management. The management was so greedy that they didn't stop the trial until more deaths were clearly occuring on the Torcetrapib arm. Still they were talking positive two days before the actual termination announcement. There is a law filed and probably we will know more about it. Totally disagree with your statement that side effect profile is more evident in large phase III trial than in earlier phase......Please check your drug developmnent knowledge.

    • "Consultant"
      Please read the messages carefully! Who is talking about the cost of the drugs only, we are talking about the quality of research and drugs!! Where did you get the figure of 1.2 and 1.7b for an innovative drug??? You mean to say a drug for CNS related and other therapeutic area cost the same? a small molecule Vs a bilogic cost the same?? Come on, whom are bluffing??? In 1992, a small biotech company called IDEC produced Rituxan for less than 200 million, look at Genzyme and their drugs, look at other small biotech companies who are coming up with very innovative drugs for less than 400 millions in cost! Big pharma is only coming up with me too drugs which less effective than the currently marketed drugs....THIS IS WHAT WE ARE COMPLAINING ABOUT HERE!!!! Quality of research!

    • FYI- It took only five years (from filing an initial IND to NDA approval) for Rituxan-a truly innovative drug for cancer. Ther are other examples. I think that the Former Pfizer makes a good point...(although in a little bit awkward manner) but nevertheless great point!!!


    • Wyeth's management is clueless how to build proper clinical data and properly file a drug application. The pipeline that is viewed as high potential is then put in the hands of Joe Mahady and Geno Germano who have no clue about proper clinical trial strategy for proper investigation and even worse, no clue of when and how to file. Schizophrenia drugs all have safety grey areas, but the severity of the condition is so great, some risk has been acceptable if monitored. But you need the proper portfolio of trials, and they tried to do it on the cheaps, clearly shooting themselves in the foot. Drug company stocks are dependent on good pipeline development (thanks you Bob Ruffalo) and skills for effective commercial development (run from Joe Mahady and Geno Germano). Evidence is clearly building, the amateurs have and are going to be cratering a high potential portfolio. Watch Bob Ruffalo leave out of frustration and Joe Mahady and Geno Germano continue sinking the stock from their commercialization failures.

    • I wonder how much (or what %) of the 800 millions goes to poor design of clinical trials or incompetence/or repition of studies because of incompetence??? and what percent is genuinely goes to discover/develop the new drug???

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