Merck & Schering-Plough Backpedal On Vytorin
14 CommentsBy Ed Silverman // December 12th, 2007 // 7:37 am
You may recall that the two drugmakers made themselves look very questionable last month when they announced a progress report on a Vytorin study called ENHANCE, which was completed in April 2006 but never released, prompting all sorts of speculation about the findings. To top it off, an expert panel - which was entirely anonymous - recommended changing the study endpoint to speed things along. Not a smart move by any drugmaker, but especially Merck, which has been desperately trying to restore credibility in the wake of Vioxx.
Now, though, Merck and Schering-Plough are changing their minds about changing their minds. Peter Kim, Merck’s chief scientist, tells Forbes that “we held two other consultant meetings and had internal discussions. We have made the decision that, while we greatly respect this expert panel, that we are not going to change the primary endpoint for the study.”
The flip-flop may be too little, too late, though. For one, an 18-month mystery is bad enough. But to then compound the problem by changing the endpoint only raises the possibility that a permanent question mark will remain over the results. And now, Congress is probing their decision. In a letter released last night, the House Committee on Energy and Commerce worries aloud about “manipulation of trial data” and is asking both drugmakers to explain themselves and fork over all sorts of records. (Here is the letter).
The congressional letter only renewed scrutiny of an episode the drugmakers would like to avoid discussing. Kim appears to have addressed the issue only in response to questions. And Schering-Plough yesterday - perhaps coincidentally? - also acknowledged the original endpoint would remain intact on a posting that suddenly appeared on its web site, and which wasn’t trumpeted by any stretch of the imagination. (Here it is).
Kim reiterates that the delay in releasing the study results were due to data quality problems in reading images, because researchers were using older methods. “When you look at sequential readings (over time), there were biologically implausible changes that occurred,” he tells the mag. “There was a decision that was made about one year ago to get into re-reading these films, and that was a decision that was made as a joint decision. “Now that we have that information, there are still questions about the quality. That is where we are.”
Actually, this is where Merck and Schering-Plough, and their study, really are: under a cloud.
BP MD
They’re only doing this because somebody is on to them and Congress has gotten involved. I don’t know about Merck, but this is the tip of the iceberg for Schering-Plough, the probablt leader in misdeeds in Big Pharma. The top two execs have a wonderful legacy - fen/phen @ AHP, human growth hormone off-label @ Pharmacia, and innumerable misdeeds @ Schering-Plough. I hope that the FDA and the Feds take this hint and hold them accountable. Where will they run to this time when the fire gets hot?
Mike L
This story also implies inaction by the FDA. Holding onto trial results for 18 months is borderline misconduct in and of itself. The FDA should require, as its regs state, that companies disclose new and updated information relevant to product safety and efficacy at least ANNUALLY. Did no one at the FDA give Merck/SP a deadline for this? I can understand granting an extension of a couple of months to “clean up the data” if concerns about data integrity are real, but this has become ridiculous. All Pharma looses credibility, as does the FDA, when things like this happen. Sad.
CV MD
It’s about time! They need to tell the real story! It’s all about protecting the flagship franchise for Schering-Plough!
Past SP
BP MD,
I agree. These two are bad news. I’ve seen it first hand and was completely disgusted by their lack of honesty and hypocrisy. They talk a good game, but they don’t back it up with their actions. They believe that they’re above rules, regulations and policies - these things are for other people to follow. I hope that the government finally does get involved.
SP
Hank
I’m a bit confused by the story. The MSP site link says the studies remain blinded. But Kim says there were “biologically implausible” results (like artery stenosis actually appearing worse)?
No doubt someone can straighten me out.
CA
Hank,
It may be a slip. They hold the data and it sure sounds like they peeked. So much for not knowing anything regarding the results! They think MDs are stupid!! Apparently, they also think the FDA, the Federal Government and Congress is stupid!!
MD
I agree. It appears that Dr. Kim had a “Freudian Slip.” Total honesty from these companies would be nice!!
Past SP
All,
Given what I know about Schering-Plough, nothing that they do surprises me any longer! Their senior management is synonymous with hypocrisy! Dishonesty is their mantra and should be in their mission statement. Certainly not the leadership behaviors and business integrity. Lack of it is much more likely. I saw it.
Past SP
merck recall
[...] Merck & Schering-Plough Backpedal On Vytorin [...]
Former SP Rep
The truth always prevails, regardless of how long it takes. Rocks are beginning to get uncovered, which will cause lost trust with the public, especially physicians. “To gain trust…” is what is stated in the back of every SP business card. I left the organization about a year ago on good terms. I lost trust with SP management, which was the reason I began to pursue external opportunties. Mu intuition was correct. Their corrupt harvest is staring to sprout. That’s what happens when you sow corrupt seed. The LAW of sowing and reaping cannot be broken. I knew the Lord wanted me out of there as well.
Prior SP
All,
I agree wholeheartedly with the past two comments. I was at SP as well and could not tolerate what I perceived as a very corrupt culture. They would skirt around the law anytime they could and try to rationalize it. Some of the things that I saw were completely disgusting. Patients were of no concern as long as they made their numbers. All that the upper management team was interested in was driving up the stock price in order to cash in their millions of dollars in options - see insider traing by CC to the tune of $40+ million earlier this year. What a travesty! All that money for not caring about people.
They also treat their employees horribly. Everyone is doing 2-3 jobs and can’t see straight. Medicine and science don’t account for anything as commercial rules! Almost the entire executive team hails from Pharmacia, which was apparently another place with very questionable ethics - see off-label Human Growth Hormone promotion for anti-aging. prior to that, many were at AHP, still another place with suspect ethics - see phen/fen suits and CC’s testimony in court. They’ve made a mint while not caring for anyone but themselves.
If there is still some justice in the US, the FDA, OIG and Congress will call them out, investigate them, and give them their just due.
In my opinion, SP shows what’s wrong with the pharmaceutical industry. Instead of being in it for the improvement of public health, many of these executives are just in it for the maximum dollars they can make in the shortest period of time.
Prior SP - and also glad I’m out of there!!!!
Harry Markopolos
I am a fraud investigator looking into clinical trials frauds where the drug companies, CRO’s, IRB’s, and clinical trials sites are cooking the data in order to falsely receive FDA approval for drugs. Basically, they’re cold-stacking (manufacturing good results going backward in time) and hot-stacking (cooking the results going forward in time for patients who dropped out of the study). They’re not submitting the Adverse Drug Events as mandated. If anyone has information and would like to be an anonymous whistleblower give me a call at 617.833.8927
survivor
The changes that need to be made are:
1. Big Pharma should not be doing clinical trials.
2. The party doing clinical trials should be required to submit ALL data and ALL trial data.
i.e. the big pharma drug cartel should not have the option of hiding the truth.
3. The party doing the trial should be independent.
i.e. not biased, logistically they should be funded by
the feds at the standard rate of pay.
3. BIG Pharma should not have “friends” at the FDA.
4. FDA employees that take bribes from the pharma drug cartel should be fired.
5. FDA should not allow employees to take bribes from the pharma drug cartel.
6. The FDA should no longer grant “waivers of conflict of interest”. If there is a conflict of interest for any reason, that person should not be allowed to decide if a drug gets approved, a warning label, or pulled from market.
7. A new law should be made REQUIRING doctors to report to the FDA any and all drug effects/events during the first 12 months a new drug is unleashed on the public.
8. Every year all drugs and food additives etc.. should automatically be reevaluated for safety.
9. Dietary supplements and natural health therapy’s should not be regulated in such a way that you will have to go to your doctor to get a prescription for vitamins or protein shakes etc.
10. The legal status on all drugs should be based purely on safety data, not racist agenda’s, political agenda’s etc.
If marijuana and AAS doesn’t kill people than it should be legal. SSRI drugs have caused an estimated 63,000 suicides, and causes intense alcohol cravings, then SSRI’s should be illegal.
11. A license to practice medicine should have limits.
A nurse shouldn’t be permitted to practice psychiatry.
Just like you wouldn’t go to a dermatologist for open heart surgery. This should be common sense, but nurses and doctors and our law makers don’t have any.
12. All hospitals should become a police state.
receptionists shouldn’t be rifling through people’s medical records and be giving medical advise. They are not doctors, and what they are doing is illegal, but there is no enforcement of the law there.
13. Emergency room registration reps should be policed since they routinely practice hate crimes such as refusing to register people for a medical emergency on the basis of disability, looks, family name etc..
14. Emergency rooms staff, doctor offices, nurses, should all be policed since they routinely alter medical data and medical records as a fraud against humanity and a fraud against insurance company’s..
15. JAHCO should have a 24hr audio/video surveillance of all medical care facility’s covering every possible angle so they can babysit hospital staff 24hrs/day-7 days/wk-365days/yr.
16. When doctors and the big pharma drug cartel are defendants in litigation, settlements should have several court ordered restrictions automatically.
A: the party offering the settlement should be prohibited from issuing a public statement in regard to the facts of the case.
B: In the case of a settlement the judge should still issue an official statement for the record.
C: All human rights violations should carry a minimum $1million penalty.
D: Any health care provider that does not provide informed consent should automatically get a guilty verdict.
E. Any abuses committed by any staff in any health care facility should carry a minimum $100k fine.
F: Any wrongful section 12 event should result in a minimum 12 month closure of the mental health facility and a minimum
$100k fine.
G: The three strike rule. Any health care provider or arm of the big pharma drug cartel who settles three litigations should be permanently banned from practicing medicine or selling drugs.
H: Any doctor who has settled any cases should not be allowed to run a clinical trial.
TOdd
Survivor, I thought this was a very wordy hoax and found it funny. But I think you are serious, let me know, I can usually get the sarcasm but this is too long to be a joke and too insane to be for real. So I am on the fence.
Wow, about all I can say, but you did put some time into it I will give you that. wow, wow, wow.