5/22/2006
Pipeline urges Amgen's Board of Directors to take action

On May 5th, GDNF advocates sent the following letter to Amgen’s Board of Directors and CEO Kevin Sharer, requesting  specific action from sponsoring company Amgen. No reply has been received as of May 22, 2006.

Letter to AMGEN Board of Directors:

May 5, 2006

We are writing to you, and all Amgen Directors, on behalf of Parkinson’s patients who participated in the GDNF Phase II clinical trial that was abruptly halted in September 2004.

We are concerned about the health of the trial participants, and alarmed as potential trial participants ourselves that Amgen is reneging on past assurances of full data disclosure, contrary to the welfare of every patient. Trust in the current informed consent process is broken. Why, we ask, should we risk our lives for a company that abandons patients at the first sign of risk to their profits?

We urge you to influence Amgen at its May 10 Annual Shareholders meeting in Santa Monica to:

• Disclose immediately their conclusions about GDNF and monkey studies. Do company studies show whether lesions were caused by the GDNF itself or by withdrawal from high doses?

• Allow compassionate use of GDNF, as approved by the FDA, for the trial patients who have retained their pumps.

• Release or sell their patents on GDNF and the related delivery systems to another entity interested in pursuing this promising research which Amgen has shelved indefinitely.

• Consider the negative impact of Amgen’s abrupt halt on the future of clinical trial participation.

The Parkinson’s research community is rife with speculation regarding Amgen’s motives and the belief that they are withholding data that undermines their decision to halt the trial. Most importantly, the patients who put their lives on the line as trial participants have suffered the loss of this life-restoring drug, and now live with the terrible uncertainty of not knowing the truth of GDNF safety.

Amgen insists they stopped the trial for safety concerns, but these have not been proven. We respectfully, but urgently ask Amgen to prove it.

Amgen publicly cited the current economic and legal climate to justify their abrupt halt of the GDNF study. Dr. Arthur Caplan, the bioethicist who represented Amgen on 60 Minutes on September 11, 2005, said that Amgen acted ethically and that recent lawsuits involving the safety of drugs like Vioxx were a huge factor. He said, "We’ve made a very jittery pharmaceutical industry. And I will tell you, at the first sign of problems in animals, even if you’re giving them a million times the dose that you’re going to give a human being, they start to say, 'That’s it. We’re outta here. This is not something we can pursue.’” *

GDNF trial participants deserve better, having endured invasive surgery to have pumps implanted in their abdomens connected to catheters in their brains. Many improved dramatically from GDNF treatment, rising from wheelchairs to return to work and to take care of home and family. Now, they are left with few options for any other kind of therapeutic help for their Parkinson’s, as they are at the end of effective conventional treatment and cannot qualify for future clinical trials. In essence, they gave their brains to science while still alive.

After thoroughly reviewing published scientific evidence and interviewing trial researchers and patients, we can only conclude that the decision to halt the trial was based on hasty, ultimately faulty data analysis with an eye on the bottom line.

In the process, we discovered enough new information to call into question Amgen’s safety claims – and change minds. The result is a Parkinson’s research community divided in their belief that Amgen was correct to halt the trial.

Trial researchers who agree with Amgen’s decision and claim no improvement for their patients met with Parkinson’s patient representatives at the American Academy of Neurology annual meeting in San Diego on April 1, 2006 (Amgen’s Donna Masterman was invited, but declined to attend). They steadfastly proclaimed that the phase II trial was a failure, however were quick to repeatedly assure us that “just because the trial had negative results does not mean that GDNF doesn’t work.”

Researchers who disagreed with Amgen were not allowed to attend, despite our request for their presence. However, their belief that the trial should be continued was demonstrated by the fact that they have not removed the pumps from their patients. In a separate meeting with patient representatives, Michael J Fox Foundation researchers confirmed our belief that the phase II trial was "inconclusive."

What we learned at both meetings underscores the need for more human studies, not less. Only Amgen has the power to proceed.

Amgen has proven to patients it cannot be trusted. The company not only foreclosed on the future of the trial patients, it also clouded the future of millions of others living with Parkinson’s who looked to GDNF with great hope, recognizing there is no other new treatment immediately within sight.

Amgen has proven its economic strength to its investors; its stock has not suffered. Now it is time to help those who invested their lives in order for Amgen to prosper. We do not believe this would damage Amgen’s bottom line - but instead would be a boon to its image, and go a long way to ease the minds of the many patients who are now fearful to take part in any clinical trial.

Please use your influence at the May 10 Annual Shareholders meeting in Santa Monica to make Amgen live up to its own rigorous standards. We must know the truth.

Sincerely,