I want to go over a few points made by the US Food and Drug Administration. Sadly cases of PML have been mounting, and it breaks my heart to see people take a drug like Tysabri, only to find out that it has put them in harms way. I’m also not a Doctor, so please do your own homework.

In Canada Tysabri is a drug of last resort, when other MS drugs have failed. But I do see Neuros who are quick to recommend this drug, even without trying the other CRAB drugs.

I also see this medication aggressively promoted when the MS patient has a generous health plan, or in some countries their national health program, promotes Tysabri as drug of first defense, which it isn’t.

I will post a link below to a warning letter the FDA sent to Nadine Cohen, Senior Vice President, Regulatory Affairs Biogen Idec. Essentially the FDA is telling them that their promotion of Tysabri “is false or misleading because it minimizes important risks associated with the use of Tysabri”

Some of the statements are very disturbing, and I hope you take the time to read the complete 5-page letter.

Here are a few points I want to highlight:

“Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy”

In other words, Tysabri is a drug of last resort, when every other drug option has failed. But as we have seen, this can be the first drug given to patients.

As you may have read from the UK and Ashton Embry, multiple studies suggest that the CRAB drugs do not delay disability. Does this mean they may promote Tysabri even more, as people reflect on the CRAB drug studies?

They tell patients that they will be monitored closely, but there is no proof that taking this drug even for a short time, will not lead to PML.

The FDA also says that there is nothing they can do to reliably treat or even prevent PML.

The FDA says: “The absolute risk for PML in patients treated with TYSABRI cannot be precisely estimated, and factors that might increase an individual patient’s risk for PML have not been identified. There are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI will mitigate the disease. There is limited experience beyond two years of treatment. The relationship between the risk of PML and the duration of treatment is unknown, but most cases of PML were in patients who received more than one year of treatment “

Then there is this statement from the FDA: “We are particularly concerned with this webcast because it presents numerous statements that seriously minimize the risk of PML.”

Biogen gave the impression that early detection offers benefits, but that has not been proven.

“This presentation misleadingly implies that Tysabri patients who developed PML and received treatment (e.g., plasma exchange) experienced lessened effects of PML and that patient outcomes will necessarily be improved if Tysabri treatment is stopped at the first sign of PML; this has not been established. According to the Warnings and Precautions section of the PI, “. . . [t]here are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI will mitigate the disease. . . . “

The FDA said: “There is no evidence that plasma exchange has any benefit in the treatment of opportunistic infections such as PML.” “It is misleading to suggest that early detection of PML and prompt discontinuation of Tysabri will lessen any effects of PML.”

We keep hearing that the longer you take Tysabri, the greater your chances of getting PML are. But it’s not so simple.

Biogen says:

“The incidence of PML increases with treatment duration.

No cases in MS during the first year of treatment

Incidence in patients treated for < 2 years appears to be <1 per 1000 Incidence in patients treated for 2-3 years appears to be about 1 per 1000

Not enough evidence patients treated for > 3 years to be confident of incidence” incidence of PML in the post-marketing setting is within the 1 in 1000 incidence implied in the label”

These claims misleadingly suggest that the risk of PML can be predicted based on an established treatment time range, when this is not the case.

Specifically, the claims above suggest that PML risk can be definitively categorized into timeframes (i.e., 0-1 year, < 2 years, 2-3 years, and > 3 years); however, there is no evidence to support such a categorization of risk assessment. The risk of PML increases steadily over time. It is misleading to suggest that the PML risk associated with Tysabri use can be determined based an arbitrary cutoff of treatment duration.

The FDA has told Biogen to stop this misleading promotion.

“DDMAC requests that Biogen immediately cease the dissemination of violative promotional materials for Tysabri such as those described above. Please submit a written response to this letter on or before April 9, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Tysabri that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.”

The few points I highlighted shows how big Pharma tries to make the risks of their drug seem smaller and more manageable than they really are.

You can only imagine what the drug reps may be saying to the Neuros who prescribe these powerful MS drugs.

I'm sorry to post this, but I find it very disturbing. I also sit here day after day, and cannot understand how the same network of MS experts keep talking about the dangers of CCSVI angioplasty, while they write so many risky and expensive drug prescriptions...

WaYnE

US Food and Drug Administration Link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM207686.pdf

Drugmaker Practices Deliver Sales, But At A Cost:

http://www.npr.org/templates/story/story.php?storyId=130644778

Dollars for Docs - What Drug Companies are Paying Your Doctor:

http://projects.propublica.org/docdollars

Biogen reports two more PML cases in October:

http://www.reuters.com/article/idUKN2024384420101020?type=companyNews

PML:

http://en.wikipedia.org/wiki/Progressive_multifocal_leukoencephalopathy