Ariad Pharmaceuticals Inc fka ARIA

[Whosetosay]

http://www.warren.senate.gov/?p=email_senator

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I ask that you investigate an evolving situation regarding Ariad Pharmaceuticals, a Biotech company based in Cambridge, MA, and the FDA. Ariad has an FDA approved drug named Iclusig (ponatinib) that is literally a miracle drug for well over a thousand people, people that have used the drug commercially or in clinical trials. For people with certain types of blood cancers such as Chronic Myeloid Leukemia (CML) that are fully resistant to other treatments, this is the only drug treatment that can save their lives. The lives saved were of very ill people who were literally at death’s door. The choices, sadly, for the folks for whom Iclusig is ineffective…either die or try a 50-50 chance to survive a bone marrow transplant (BMT), provided they are even healthy enough to attempt a BMT. Most just die.

Recently, the FDA reviewed its accelerated approval of the Iclusig and forced Ariad to ‘voluntarily’ withdraw it from the market. The reason given by the FDA was that they considered the number of Serious Adverse Events (SAEs) caused by the drug to have skyrocketed over time since the drug was approved.

The problem with the FDA’s position is two-fold. Statistically, over time, the number of SAE’s actually drops, meaning that the longer the patient population stays on the drug, the rate of SAE’s actually drops somewhat. Secondly, the FDA changed the definition of SAE’s to include virtually any side effect, serious or not, and attributes them to the treatment. This definition change has literally doubled (and more) the FDA’s SAE count from when the drug has been approved.

Keep in mind, this drug's registration trial was on the sickest of the sick patients with CML, patients who had failed all other drugs and treatments. Most were older, with many other afflictions, and physically damaged having gone through years of other similar medications to which they had become refractory.

To boost their claim, the FDA listed in a press release the events of some rather unfortunate side effects to illustrate their point, ignoring that the very ill patients had other conditions besides CML, notably diabetes, that could very well have been the leading cause of those SAEs. In some cases, the FDA points out at least two patients in their 20's who experienced FDA-defined SAE's, ignoring to state in their press release these patients were in the end state, or blast phase of the disease, with no alternative treatment than Iclusig. The drug saved one, the other sadly did not respond to treatment. Few of these very ill patients actually die from a SAE while the hundreds and hundreds of patients are alive today because of Iclusig.

Immediately after asking (forcing) Ariad to stop selling the drug, the FDA told existing patients that they could apply through the FDA so that Ariad would provide the drug for free. And that is on-going. Nothing has changed, except that this upstart biotech, Ariad, is slowing going out of business by keeping these desperate patients, who were paying for the drug, alive with free drug.

Virtually every leading physician in the CML field has written the FDA in support of Ariad, and countless patients have also. There is an enormous gulf between these doctors' view of SAE's vs. the FDA's views, in one case 4% SAE's for the doctors, 24% for the FDA. Other disparities are even greater. How can the disparities be so great?

Nonetheless, doctors and Ariad have designed dose limiting strategies for this powerful drug, Iclusig, techniques that are fairly common with cancer drugs to address the FDA’s concerns, and is reworking its label to limit SAE prone patients access to the drug. Still, time is running out for new patients now blocked from the drug.

Compounding this, much damage has already been done to Ariad. Ariad is in deep financial danger. Last week, to survive, the company laid off 40% of its Cambridge, MA staff, that is 200 scientists and other workers. Promising trials of the drug in other very nasty cancers, notably GIST, remain closed to new patients. Those shut out will suffer or die on some inferior treatment.

Please look into this. I ask that you speak to Ariad management, get their side of the matter. Then, likewise, to your FDA team. Something just isn’t right. Consider if the FDA is overreacting here. Permit Ariad to immediately resume selling the drug to those for whom life would end without it.

As an investor in Ariad, I am saddened to see the tortuous and unnecessary destruction of this company, and the end to its groundbreaking treatments. The FDA’s actions are antipodal to their mandate, and to government itself. Instead of helping and protecting patients, it is hurting, in some cases certainly, killing off desperate patients who are not permitted to start on the drug now. Patients dying, jobs lost, FDA dragging its heels. It’s not the way government was meant to be. I know you care about good government oversight. Please help.

Ariad’s phone [phone] CEO email [e-mail]

Thank you