Drugmakers in hot water with NY Attorney General Posted by Liz at 01/28/08 10:23 AM

New York Attorney General Andrew Cuomo announced yesterday he would subpoena Merck and Schering-Plough Corp for information and documents to investigate if the companies hid research on the heavily advertised cholesterol drug Vytorin. The two companies are partners on the drug.

The study, Enhance, was released on January 14th and showed that Vytorin (a combination of the drugs Zetia and Zocor) does not work any better than Zocor alone in reducing fatty plaque in arteries. The investigation will examine the marketing of Vytorin and the sale of the companies' stocks to investors before the results were disclosed.

“We will investigate and, when appropriate, hold accountable drug companies for engaging in irresponsible and deceptive conduct and any deceitful marketing of prescription drugs," Cuomo said. "Drug companies are on notice that concealing critical information about life-saving prescription drugs, profiting at the expense of patients' health, and wasting taxpayer dollars, is simply unacceptable."

Although researchers finalized their conclusions in April 2006, the companies didn't make results public until two weeks ago. The companies blamed the complexity of the data as the reason for delay. They certainly enjoyed one last hoorah--the drug reaped in $5 billion in sales last year.

The closer you look at this controversy, the messier it gets. Members of Congress want to know why the companies sat on these results for almost two years. State Medicaid agencies, assuming improved results with Vytorin, paid millions for the drug during this time, and could have saved money buying equally effective, older medicines. New York alone paid a whopping $21 million just for this drug.

The companies also changed the “primary endpoint” of the trial (the result being measured to see if a treatment worked) after it was completed. This has left some doctors skeptical. ''This sounds highly unusual to me,'' said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. ''You need to live with your primary endpoint.''

Hopefully lawmakers will stay true to their word and fully investigate what’s happened here. In the meantime, we’re all waiting for the day when this kind of news will shock us.

comments (16)

1 Posted by Lonnie C. Hoyle at 01/31/08 11:46 AM

I'm concerned about this since I have just been prescribed Vytorin. I have had both Hepatitis B and C, with a full recovery from Type "C". My new endocrinologist suggested that I go ahead and take it for now and see what kind of results show up on my next visit. I have only been taking Vytorin about 3-4 weeks now.

2 Posted by Patricia Weberman at 01/31/08 11:51 AM

Lies and deceit perpetuated by drug companies and their congressional lobbyists to promote and market drugs which do not work, cause dangerous side-effects, cause cancer and mislead the public by fear tactics are reprehensible. The FDA does not protect the public.

3 Posted by Paul at 01/31/08 01:25 PM

My personal physician recently took me off off Zetia, saying its benefits were negligible at best. Zetia had been prescribed for me about two years ago by another interim physician I had. Perhaps the drug saleslady got to him.

4 Posted by John at 01/31/08 02:59 PM

My insurance company recently informed me they were raising the co-pay for Vytorin to the highest tier - 2 1/2 times the cost of the lower tier. I told my doctor to change me to another drug which he did. Then I read about the infamous study that was finally released. Vytorin not only failed, but with the Zetia my numbers are now worse.

5 Posted by Edward A Ross at 01/31/08 03:11 PM

Vytorin is the tip of the iceberg.

As several reputable books that have been recently published, including "Overdosed America", have pointed out and many studies have shown, anti-cholesterol drugs are ALL unnecessary and increase all-cause mortality.

6 Posted by Victor Arkin at 01/31/08 03:22 PM

I've been on Vytorin for over a year and followed closely by a Cholesterol control unit of my HMO. I've discussed the drug with my physician since the manufacturers' study was released. He was of the opinion that the drug has benefits in high risk patients such as me - overweight, smoker, triple heart by-pass surgery.

7 Posted by Charles at 01/31/08 03:35 PM

I can't tell you how betrayed and upset I feel for pushing my PCP into prescribing Zetia for me when I first learned of it, several years ago now. I have exceptionally low, genetic-caused HDL cholesterol and was looking for a solution via a prescription drug. I thought that Zetia was the answer to take in combination with my daily dose of 40 mg. of Lipitor. How wrong I was! Obviously, I am no longer taking Zetia.

Why doesn't the FDA do the best possible job of checking and rechecking our food and drugs to make sure that they are as safe as humanly possible? Lord knows we pay enough taxes! It is so sad that our government is now so strongly influenced by those lobbying for huge, overly wealthy corporations at the expense of us *commoners.*

8 Posted by Marnie Bottesch at 01/31/08 04:13 PM

* New York Times January 14, 2008

Zetia, a cholesterol-lowering drug prescribed to about 1 million people each week, has no medical benefits, according to a trial by Merck and Schering-Plough.

While the pill does lower cholesterol,trials have NOT shown that Zetia reduces heart attacks or strokes, or that it reduces plaques in arteries that can lead to heart problems.

The current trial, which studied whether Zetia could reduce the growth of plaques, found that plaques grew nearly twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone.

Patients who took both Zetia and Zocor received it in the form of Vytorin, a pill that combines the medications.

Experts have called the results “shocking,” saying that Zetia should not be prescribed unless all other cholesterol drugs have failed.

The trial was completed in April 2006, with results scheduled to be released in March 2007.

(So for almost 2 years they sat on the results)

* New York Times January 14, 2008

Popular Cholesterol Drug Found to Have No Medical Benefits

pills, medication, drugsZetia, a cholesterol-lowering drug prescribed to about 1 million people each week, has no medical benefits, according to a trial by Merck and Schering-Plough.

While the pill does lower cholesterol by 15 percent to 20 percent, trials have not shown that Zetia reduces heart attacks or strokes, or that it reduces plaques in arteries that can lead to heart problems.

The current trial, which studied whether Zetia could reduce the growth of plaques, found that plaques grew nearly twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone.

Patients who took both Zetia and Zocor received it in the form of Vytorin, a pill that combines the medications.

Experts have called the results “shocking,” saying that Zetia should not be prescribed unless all other cholesterol drugs have failed.

The results also add to the controversy over Merck and Schering-Plough’s delays in releasing them. The trial was completed in April 2006, with results scheduled to be released in March 2007. However, the companies missed several deadlines, and only agreed to release the results after media outlets focused on their continued delays.

Zetia and Vytorin account for about 20 percent of the cholesterol drugs on the U.S. market.
Sources:

9 Posted by Connie at 01/31/08 04:44 PM

The public is not fully informed about Vytorin. The results of studies show that Vytorin does reduce LDL which is why most people are taking it in the first place. The study showed that Vytorin did not reduce the amount of plaque already present in arteries so it could not use that claim in the label. The press usually selects a few phrases and because they are not knowledgeable about the medication and it's claims they come to erroneous conclusions about what the studies were designed to show and what the drug(s) do or don't do. Speak with the prescribing physician and if they cannot fully explain the mode of action of the drug that they prescribe and also clearly explain the design of the clinical trial, the results and the interpretation of them, I suggest finding another physician who is qualified to do so.

10 Posted by Kevin at 01/31/08 08:02 PM

I have had very high cholesterol and triglycerides for a long time. I had numerous doctors put me on various drugs to lower my numbers. unfortunatly nothing worked well only brought them down a few points. Then my doctor that I have now put me on Vytorin 10/40 I took it everyday and my numbers came way down my doctor was very pleased. I stopped taking the meds and my numbers went up again so I started to take the Vytorin again and yes they came down again. I think this pill is fantastic. I might also add that I am a heart patient with 3 stents and six catherizations, plus I am a stroke survivor of 2 strokes. thanks for a good pill that does not give me any side effects and keeps my numbers low where they should be

11 Posted by Curtis Churico at 01/31/08 09:25 PM

Hello,

I work in the Natural Health Alternative arena.

I'd like to offer some advice on Cholesterol issues, even the people who think it is hereditary, and they have had no luck finding anything to help them.

Do not give up, there is something that will help you. I hear the success stories in my store.

The supplement is called "sytrinol" and it is composed of orange and tangerine compounds that have been discovered to help those with the most stubborn cholesterol problems.

Please try this before taking any drug from your doctor. All cholesterol drugs rob your body of CQ10, your doctor probably does not even know that, if he does, he surely will not tell you.

Good luck to all.

HEALTH & HAPPINESS,

Curtis Churico

12 Posted by Wayne Carpenter at 01/31/08 10:19 PM

I strongly suggest that no presciption drugs be allowed to be advertised on the TV or other media to the general public. Let the physicians decide whether you need a drug or not. Of course, in order for the physicians to properly choose the correct drug or drugs, they need accurate data.

13 Posted by KD Wildmo at 02/01/08 11:25 AM

There was a good article in the NY Times titled, "What's Cholesterol Got to Do With IT?" about whether there is a link between cholesterol and heart disease. Maybe people ought to do more research than be blindly lead down the primrose path of putting more money into the pockets of the drug companies an the medical community. This is the link to the article:

http://www.nytimes.com/2008/01/27/opinion/27taubes.html?em&ex=1202014800&en=32469166556f3544&ei=5070

14 Posted by Ronald DeFrancesco at 02/02/08 07:47 PM

Well, where do I start, I have had two heart attacks have used a couple of cholestorol medicines. My faith in the drug indusries is now oficially shattered ,it is now time to seriously look towards alternative cures,that are natural and have less side effects.We should all take a stand and hit them where it hurts in their profits ,look for alternative treatment now and make them suffer period.

15 Posted by Shelia at 02/04/08 10:00 PM

I am personally sick and tired of all the drug ads on TV and in magazines. We are being bombarded with everything from restless legs syndrome to ED. The FDA need to do its job and be more stringent about allowing these drugs to reach the market. The side affects of most of these medications makes one wonder what is worst the condition or the side effects.
My doctor subscribed Naispan for my cholesterol and when I searched for the side effects I decided I'm not willing to endure them and not change my lifestyle. A pill is not going to fix everything and I sure as hell do not want to trade for something worst.
We had better look out and thing for ourselves because the FDA and big Pharm is not!

16 Posted by zach flake, md at 03/13/08 12:15 PM

As a physician, I believe we are entering the Golden Age of generics. Dozens of brandname drugs have effective, lower-cost alternatives out there.