Tag: <span>FDA</span>

If you’ve ever wondered how new Multiple Sclerosis drugs are developed, evaluated, and finally approved for the market, Bloomberg.com offers a link to the video of the FDA Committee Meeting on Novartis’s new Gilenia, the first pill for Multiple Sclerosis.

After drug testing and before the FDA approves a new medication, a panel of health experts considers the drug studies and, if the panel is satisfied, recommends approval to the FDA for approval. The FDA usually does as the panel suggests.

The panel reviewing Gilenia recommends it as safe and effective for controlling tremors, concentration problems and other symptoms of relapsing remitting MS.

If the medication’s side effects do not derail the FDA’s approval later this year, Gilenia will be a welcomed medication for MS patients because it is the first MS treatment available in pill form. Approval would mean no more routine injections or infusions for those who take it — no more needles or injection site reactions.

Reported side effects of Gilenia include eye disorders, heart problems and lung problems. In spite of these, the panel recommend approval of the drug for the treatment of Multiple Sclerosis.

With each medication they choose to take, MS patients are faced with the persistent question, “Will my MS treatment be worse for me than the long term effects of the disease?” Because this is a new medication, there really isn’t an answer to this question yet. Not enough people have taken it for enough time for researchers to know the long term effects.

In light of the side effects, the panel did recommend Novartis study the effectiveness of lower doses of Gilenia.

More information about Gilenia:

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You may think your pharmaceutical expenses and drug costs are high. They are.

Part of the reason is that drugs are made by corporations that must return value to shareholders. To do this, they must sell drugs. To sell drugs, pharmaceutical companies have paid doctors to promote their drugs. The money paid to doctors is an expense which increases the cost of drugs. That’s the business.

One step beyond the business, though, is corruption. At least one drug company has pleaded guilty for paying doctors to recommend drugs for diseases for which the drug was not approved. And there are new allegations the drug company may have known the drug was not even effective against the diseases for which it was being promoted.

That’s all background.

Pfizer Inc., the world’s biggest drugmaker and the company that created Neurontin, has said it will begin (next year) disclosing all payments of more than $500 it makes to doctors.

According to the MSNBC article, “Pfizer to disclose payments to doctors next year“, Pfizer is doing this “after introduction last month of legislation to require such disclosures, and revelations of astronomical payments to some doctors that were not revealed to universities and hospitals that employed them.” In other words, this is an example of another corporate entity becoming interested in transparency only after regulatory requirements change.

While politicians suggest this is a good move because there is so much public money that passes to drug companies, I believe the real value in this is that it makes transparent the relationship between a doctor and the medications the doctor prescribes.

Here’s what I like about it: suppose a doctor makes a presentation to an MS support group and talks extensively about one of the MS injection therapies and only mentions the others in passing.

Don’t you want to know whether the doctor is focusing on the one medication because he or she finds it really is the best medication and not because he or she is being paid to give a speech? As I wrote in September of 2007 in “MS Medication, Insurance Coverage and 2 Ounces of Gold“, I sure want to know!

Here’s why Pfizer’s decision to report these payments to doctors is important. Pfizer pleaded guilty in a legal settlement related to an accusation it had illegally paid doctors to prescribe Neurontin for uses not approved by the FDA. Pfizer paid penalties of $430 million for paying doctors to prescribe billions of dollars of Neurontin to patients with diseases for which there was no evidence of Neurontin’s effectiveness.

Newsweek has a good article that summarizes the Pfizer/Neurontin legal issues: “Pfizer’s Headache: Lawsuit charges drugmaker was deceptive about Neurontin.”

Pfizer’s behavior offers the clearest example of why transparency in the doctor/pharmaceutical company relationship is important.

Interesting to me is that while Pfizer paid $430 million (about one quarter’s sales of Neurontin), no physician was charged. I think this must be why: Doctors have to be able to trust the information they receive from pharmaceutical companies. Certainly, no physician with integrity would prescribe or promote a drug they did not believe to be effective.

Caregiver Tip: The quickest way to get to the point of this issue with a doctor about a prescription medication is to ask, “Do you receive money from the drug company that makes this medication?” Once that is on the table, you can then talk about whether or not the medication is being prescribed because your doctor really does believe it will be effective.

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Use the FDA’s MedWatch for the Latest Drug Safety Information. If a medication you take requires additional warnings, you can learn about it on this web site of the U.S. Food and Drug Administration.

MedWatch is the FDA’s web site for reporting current medication safety information about drugs and medical products which are regulated by the U.S. Food and Drug Administration. The “What’s New” column on the left side of the home page is where the news is posted as it becomes available. You can subscribe to receive safety alerts by email.

On 10/24/2007 the FDA and Cephalon (manufacturer of Provigil) notified healthcare professionals of an updated WARNINGS section of the prescribing information for the drug. According to the posting,

“Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.”

Obviously, this is good information to know. Other than the specific side effects, it means Provigil is like any medication. One must balance the side effects (and potential side effects) against the good the medication does. The information about these additional side effects serve as a reminder than any chemical one uses to modify the way a brain works may hold unexpected dangers.

It’s good to know that should my wife suddenly experience any of these side effects, her Provigil may be the reason. Of course, these additional potential side effects are also listed in the prescribing information for a couple of her other medications, too. Modifying brain chemistry is a tricky thing.

Here’s what surprises me. I did not learn of the FDA’s updated warnings from a healthcare provider. Nor did my wife receive information about the updated warnings from a doctor, pharmacist or the drug manufacturer.

I first learned about the new prescription warnings by reading it on a financial news web site.  TheStreet.com posted an article on 10/24/07, by Elizabeth Trotta, titled “FDA Warns on Cephalon’s Provigil”.  The Multiple Sclerosis Foundation has a good article about this issue, too: “New Warnings for Provigil“.

Cephalon’s “Newsroom”, the page on their corporate web site for news releases, provides no mention of the updated warning (I’m exploring the Cephalon site on 11/04/07). Cephalon’s web site has a page of corporate information for investors, but nothing there is about the 10/24/07 FDA announcement of the updated prescription warning.

Cephalon also has a product-specific web site for Provigil at www.provigil.com. The Provigil.com web site offers a lot of good information about the medication and its uses. If you or someone you know takes Provigil, the Provigil.com web site is a great resource for you. The important information for patients about side effects and medication use is available from the upper right hand link, “Patient Information”. The information is dated August 2007 (before the FDA MedWatch notice).

The lesson for patients and caregivers? Use MedWatch AND the web sites of drug manufacturers to stay on top of important drug safety information.

How Drug Safety Information Seems to Flow

MedWatch is the official place to read the latest drug safety information. Generally, this seems to be how drug safety information flows: Drug safety news appears initially on MedWatch. Next, the news media (medical news and financial news) pick up on the MedWatch postings and write articles to inform the public of significant drug safety news. Then drug manufacturers and medical professionals inform patients.

However, in Cephalon’s case with Provigil, the drug manufacturer was ahead of the FDA MedWatch posting. The Provigil FDA Approved Labeling (PDA File) was updated on August 17, 2007 and on September 12, 2007, a “Dear Healthcare Provider” letter (PDF File) was produced which details the updated information and warnings.

Good job, Cephalon.

Caregiver Tip: Know the names of all the drugs taken by the MS patient for whom you care. Check MedWatch regularly to learn about drug safety news related to these medications. I’ve added a link to MedWatch in the right hand column. Also, visit the web sites of the drug makers for current information. As they say, “knowledge is power”.

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