FDA Approves New Wonder Drug… on Just 8 Weeks of Testing
The FDA has just approved a new antidepressant drug. It’s called vilazodone. And it’s been created by a small biotech company called Clinical Data.
The story you’ll read in the newspapers is that this new drug is a Good Thing. That’s because it’s the first antidepressant that doesn’t seem to have sexual side effects.
In theory, that is good news for the 18 million Americans dealing with depression each day.
But while this new drug may not impact sexual function… does it actually offer any real benefits? And while the FDA has approved this drug based on clinical trials… are those trials as strong as they seem?
Stay with us as we uncover the truth behind vilazodone.
What’s So Special about Vilazodone?
The answer is very simple. Initial studies suggest that vilazodone doesn’t affect sexual function. That’s a big difference from the other drugs out there.
“Patients with depression usually experience difficulties with sexual functioning,” says Chrystyna Bedrij. She’s a biotech analyst at Griffin Securities, a research-driven investment banking firm. “This tends to be worsened by antidepressant treatments.”
But she notes that these early trials seem to show that the new drug doesn’t affect sexual function in the same way. That’s good news for people with depression.
It’s even better news for the pharmaceutical companies.
Wall Street analysts say Clinical Data stocks are shooting up from $18 a share to over $30 a share. They’re saying it offers blockbuster returns. And large investors are already buying up major stakes.
Clearly, there’s money to be made in vilazodone. But it’s even more than that. It may refuel the whole industry.
The Financial Picture
Antidepressants are big business. More than 200 million were prescribed in 2009. Sales totaled more than $12 billion.
The drug makers have invested heavily in this area. But things are about to change. Those drugs are about to lose their patent protection.
And when that happens, generic alternatives will undercut the big drug makers.
This is why vilazodone is so important. It’s the first new drug approved for sale in more than 15 years. That means brand new patent protections. And all the major drug companies want a piece of that. They’re already talking to Clinical Data about a possible takeover.
So there’s no doubt… vilazodone is good news for the drug makers. But is it really as good for the public as the newspapers are reporting?
Just What Did the Clinical Studies Show?
The trials show two big problems with the drug.
During the clinical trials only the highest dosage tested proved effective. Despite this, the maker will sell the drug in 10-, 20- and 40-mg tablets. But their trials showed it to be only slightly effective when given at the highest 40-mg dose from the second week onwards.
The second problem is the length of the trials. Those findings were based on just eight weeks of testing.
Experts say the trials didn’t allow research into the effects of prolonged use. There simply wasn’t enough time to gauge how effective the drug would be. Or how dangerous.
Dr. Peter Breggin compares the rush job to the original Prozac trials.
“Prozac was tested in clinical trials lasting a mere six weeks before it was approved by the FDA and unleashed on the marketplace,” says Dr. Breggin. “The consequences were unforeseen. And then denied by advocates of the drug. The FDA-approved labels for antidepressant drugs now recognize these harmful outcomes.”
In the case of Prozac, these side effects resulted in “violence, suicide, and aggression.”
Dr. Breggin should know: he’s a legend in the field of mental health. He was trained at Harvard and went on to serve on the faculty. He’s also taught at John Hopkins University. During his career, he’s worked for the National Institute of Mental Health. He has also helped patients deal with depression in private practice for almost 45 years.
And Dr. Betram Karon – Professor of Psychology at Michigan State University – calls him “the conscience of psychiatry.”
That’s two strikes against the drug. Only very high doses work. And the long-term effects are unknown.
So Just How effective Are Antidepressants?
And it’s not just Dr. Breggin who takes issue with anti-depressants. Dr. Irving Kirsch is a professor of psychology at the University of Hull in the U.K. He’s also professor emeritus at the University of Connecticut in the U.S.
His specialty is meta-analysis. That means he studies the results of previously conducted clinical trials and analyzes them statistically. And he’s been studying antidepressant drugs for years.
His first meta-analysis examined the size of the placebo effect in the use of antidepressants.
He found a big placebo effect… and a very small drug effect.
He further obtained files from the FDA. That included data from trials that were not published. Kirsch’s analyses of the FDA’s own data showed that “the difference between antidepressants and placebo is not clinically significant.”
He based his conclusion on criteria used by the National Institute for Health and Clinical Excellence (NICE).
He says that his research shows that antidepressants in general are not effective.
“Documents obtained from the FDA revealed an explicit decision to keep this information from the public and prescribing physicians,” says Dr. Kirsch.
Conduct as Many Trials as You Like. Just Show Us Two That Work
This new approval underscores an ongoing problem with the FDA’s policy of testing. On paper, FDA approval requires at least two placebo-controlled trials. Those trials must have positive results. But that doesn’t mean trials are limited to just two. It doesn’t matter how many trials fail to demonstrate the drug’s effectiveness along the way.
For example, the efficacy of Prozac could not be distinguished from placebo in six out of 10 clinical trials.
But, one trial was judged to be successful. It was based on such a small group of participants that only eight patients taking Prozac completed it.
Companies can hand-pick the two best outcomes for its drug to present to the FDA. Even if it takes 100 negative trials to get two positive ones.
And the FDA is fine with this.
The Dark Underbelly of Antidepressants
Plenty of evidence shows antidepressants to be ineffective. And there is a long list of harmful side-effects that doctors don’t tell you about.
For example, patients taking Prozac suffer from gastrointestinal problems and weight gain. Some get headaches. Others become agitated. Emotional numbness is common. And 70 percent suffer from sexual dysfunction.
If that wasn’t enough…
These drugs can be very addictive. As time passes, patients need higher doses to enjoy the same benefits.
Stopping treatment is also risky. It needs to be carried out under careful medical supervision. Withdrawal can last for days. And some patients become depressed, suicidal, or even violent.
Dr. Breggin says antidepressant-induced behaviors are identical to those perfomed on PCP and cocaine.
He says antidepressants “lead to loss of self-control with violence, suicide and aggression.”
He’s seen dozens of patients commit suicide or violent crimes while using antidepressants.
And he’s repeatedly called on the FDA and U.S. doctors to educate the public about the risks of antidepressants.
So What Can You Do?
There is no doubt that depression is a serious, life-changing condition. But signing up to take a barely-tested drug – like vilazodone- is risky business.
“Taking [drugs] is not the answer to our mental health epidemic,” says Dr. Mark Hyman. “The cure lies in rebalancing the systems in your body.”
He’s a Massachusetts physician who serves on the Board of Advisors of Georgetown University. And he believes there are much less risky alternatives to untested drugs.
He offers three easy-to-follow steps that promote a healthier, happier mind.
Vitamin D3 supplementation. He says vitamin D3 deficiency can cause depression. But you can get vitamin D3 into your body. Try to get more sunlight. Also, eat wild-caught salmon and sardines. And take cod liver oil and vitamin D3 supplements. Dosage ranges between 2,000-5,000 IU/day.
Omega-3 fatty acid intake. Omegas 3s have been linked to good mental health. Try to get plenty of cold water fish in your diet. And eat high-fat fish, nuts, seeds, and organic fruits and vegetables. Again, supplement with fish oils.
Studies also link exercise to improved mental health. You should try to exercise five times a week for about 15 – 20 minutes at a time.
Further studies show that meditation and yoga improve mood. They are simple, natural ways to achieve relaxation and release from stress.
Plenty of emerging studies and research show how omega 3 combats depression. Members of our Natural Health Dossier health advisory service recently gained access to a special research report all about depression and omega 3s.
This report reveals how this all-natural remedy is a completely safe alternative to antidepressant drugs. And looks at the best ways to get this vital nutrient into your diet… and how much you need to take.
To get this report – and additional in-depth research on critical health issues – simply sign up for Natural Health Dossier. If you are not a current subscriber to NHD you can get more information on how to become one here.
To your health,
NHD “Health Watch”