Shame on Robert Goldberg

This letter was written regarding the problems with getting cures to patients. (Please support the Abagail Alliance. Robert Goldberg published an article about he problem on a biotecnology website. Allowing a right wing hit man to publish propaganda pieces cheapens and discredits people who are trying to change the FDA approval rules in ways to benefit patients.


Dear Biotechnology I. O.

I enjoy your site. Most article links are very informative. I enjoy reading unbiased current information in the biotech field.

However, you do a disservice to your readers and your site when you reference propaganda articles written by hired guns whose only agenda is the deception of the American public for the benefit of their masters who pay them so well.

Robert Goldberg is one such amoral, hired gun who you linked to in the article, “Streamlining drug approval” from Washington Times. He writes for virtually every propaganda organ in the deception quiver of the wealthy. His articles serve only to try to make more money for his masters by persuading Americans to believe something which is neither true nor in the best interest of ordinary Americans.

I agree with the premise of his article. There are huge problems with the FDA drug approval system. My youngest son is crippled and completely disabled from a rapidly progressing autoimmune disease that he had no sign of three years ago. His chances of living for five more years are very remote.

This horror has been compounded by the many different cures for autoimmune disease in laboratory animals that have been discovered in the last three years including a "vaccine" recently announced by The Weizmann Institute in Israel. Other cures have been announced by the Salk institute in San Diego, Jeffrey Bluestone at UCSF, the La Jolla Institute of Allergy and Immunology and the Burnham Institute. But none of the revolutionary treatments or cures ever gets tried on humans. When I have contacted these institutions their answers are inevitably the same. They say a variation of the following, "We are a research institute. We do not do translational work. We do not do clinical trials. That work is up to someone else." I ask, “who is that someone else?” They have never have an answer for that question--just some vague someone, some place else will do it, they are sure.

Meanwhile my son suffers in pain and worsens daily. He can no longer walk unaided. He cannot pick up a fork. He cannot even talk as the joint holding his vocal cords is frozen.

There is a need for “Phase Zero” Clinical Trials of novel therapies and medications, using fully informed volunteers, without Institutional Review Board paperwork and hold up. Some patients would be hurt. Some will undoubtedly die. But the techniques and medications would get to millions of others years earlier. Those who were hurt and died would be heroes instead of anonymous victims of the relentless diseases they now suffer from. My son will die without a new therapy. His death will be pointless and without value. At least with “Phase Zero” clinical trials, if worst came to worst, he would have contributed to cures for others. I, too, have an autoimmune disease. I would happily take join any Phase Zero trial that might help my son.

If Robert Goldberg actually cared about real patients rather than his sponsors paycheck these are the kind of issues he would address.

He would rail against the intentionally difficult system of reporting adverse reactions put in place at the behest of big pharma using their financial might to bribe Congress to write the laws and regulations on reporting the way Big Pharma wants.

There absolutely are stupid bureaucratic delays for crucial medications. I absolutely agree on that point with Goldberg. But I come at it as a father of a patient not as paid writer. Below is an example of a ridiculous FDA delay:

Rituxan, an obvious autoimmune candidate medication, has taken a decade from initial FDA approval for Type B leukemias to approval for use against Rheumatoid Arthritis. A decade is an unconscionable delay!

Even now with its proven efficacy for RA, it has not been approved for the whole host of other autoimmune diseases with similar pathology to RA.

Obviously if it helps RA by killing off the rogue B cells that produce the maladapted antibodies that are attacking the joints, it would also work to kill the rogue B cells in psoriatic arthritis that attack tendons, the rogue B cells in MS that attack myelin sheaths around nerve cells. Virtually every one of the eighty or more autoimmune disease start with rogue B cells producing maladapted antibodies. Eliminate the rogue B cells and you eliminate the maladapted antibodies. Disease progression stops.

Yet the FDA requires each autoimmune disease to be tested separately. Approval for a new autoimmune disease comes only after hundreds of millions of dollars and years of waiting for each of these diseases. Why should we have to wait? Why doesn’t Goldberg care about this issue?

Insurance companies do not pay for off label uses, so millions are effectively denied Rituxan’s benefits. Does Goldberg bring up the issue of no coverage for effective uses of medications that are off label therefore not reimbursed? No, no one paid him to say it.

Rituxan is also “old technology”—a monoclonal that is part mouse instead of being a fully human antibody. New monoclonals are fully human.

Had Rituxan been approved a decade ago for autoimmune disease; a market for new technology, anti-B cell medications would have rapidly developed. Those new technology anti-B cell medications with far fewer side effects would be on the market now. Instead we will have to wait another five years for the newer monoclonals. Does Goldberg bring up this issue either? No, who’s paying him to say that? No one.
He writes for the Washington Times, the American Spectator and other completely biased propaganda papers whose sole purpose is deception and disinformation to confuse the American public. Please do not link to his articles any more. For goodness sake, he is a senior fellow at the fascist Manhattan Institute! Why not link to flat earth articles, moon landing deniers, and anti-evolution articles, too?

Your site is either scientific site or it isn’t. If you are going to reference propaganda pieces at least label them as such. Yes I saw the word ‘editorial.” And no that word is not sufficient. An editorial in JAMA or some other reputable medical journal is for the purpose of advancing science for the general good. That kind of editorial is a very different kind of writing from the propaganda pieces of Goldberg meant to deceive and hurt the common good for the benefit of those who pay him to write the propaganda. His was not an editorial, it was a paid for propaganda piece and should have been labeled as such.

darwindad@cox.net