Jenny McCarthy and Autism

Jenny McCarthy has been a darling of Autism advocates for drawing attention to this horrorific disease. But she’s recently gone off the reservation claiming she has cured her son’s autism by changing his diet. (See article)

If proven true, Jenny McCarthy would be the leading contender for the Nobel Prize in Medicine. But here’s why this is suspect.

Like many emotive parents, Jenny McCarthy has subscribed to the disproven theory that thimerosal in certain vaccines causes autism. More specifically, thimerosal causes autism through both biochemical as well as physiological changes in the human brain. So when Jenny McCarthy claims that she cured her son’s autism through a better diet and B12 vitamin shots, what she is saying is that she was able to correct BOTH her son’s brain chemistry imbalance as well as reconstruct his brain structure back to normal and fixing the physiological damage.

Improbable? Sure. But if true, it would be a complete revolution in medicine and put her in strong contention for the Nobel Prize. Of course there is absolutely no medical evidence of this, but I’m sure Jenny McCarthy would welcome a team of researchers to study her son and this diet in the hopes it would help other parents.

In this situation, there are only a handful of scenarios:

• Jenny McCarthy’s son has autism and she has stumbled on a revolutionary cure for this spectrum of disease known as Autism.
• Jenny McCarthy’s son was misdiagnosed and he did not have autism, but rather he has some other condition and it was cured by this diet.
• Jenny McCarthy’s son may or may not actually have autism. Jenny has been giving him this diet, she feels like it has helped his autism and she feels good about herself for doing something about her son’s problem. But there is no evidence that the diet has helped or harmed her son in any way (i.e., placebo effect).
  

I’ll leave it to you to make your own determination of the most likely scenario.

The facts remain. There is a tremendous body of evidence disproving the faith-based belief that thimerosal in vaccines causes autism. Thimerosal has been removed as a vaccine additive, yet incidence rates of autism continue to increase (both in children vaccinated with non-thimerosal containing vaccines as well as in children who have received no vaccinations at all…in this country as well as in other countries).

Parents want to believe. But belief doesn’t make it correct, or make sound science or medicine.

Cancer Vaccines Still Struggling

Cancer Vaccines have long been an area of promise in cancer research. And they have been an area of frustration for pharmaceutical and biotech companies. From negative clinical trial results to the FDA changing protocols mid-trial, it is a challenging time to be involved in the development of cancer vaccines.

Cell Genesys ended the trial of its GVAX candidate in prostate cancer back in August (see Cell Genesys Drops GVAX Trial). Now, the company is shedding the majority of its workforce in a desperate bid to stay alive (see SF Chronicle).

Sanofi-Pasteur is one of the largest companies engaged in cancer vaccine research. However, the Sanofi-Pasteur cancer vaccine initiative seems to have gone into deep hibernation and its ALVAC technology hasn’t gone anywhere in recent years. A new melanoma trial is underway, but it will be years Sanofi can evaluate whether the ALVAC technology will continue.

Oncophage from Antigenics has had mixed results, demonstrating increased media survival of four months (see Antigenics’ Oncophage Gets Mixed Results). The product has been approved in Russia and now has an FDA export certificate, but Oncophage does not have regulatory approval in the U.S. or EU. Antigenics has filed for EU approval, so this is one to watch. I like Antigenics chances.

Finally, who could forget Dendreon? Their lead candidate Provenge received a resoundingly positive Advisory Committee endorsement, only to be torpedoed in a back room deal with the devil between Dr. Howard Scher and the FDA’s Richard Pazdur (see Can Provenge Get Any Weirder?). The company has had to go back to the drawing board on the trial data. I believe Provenge will ultimately be approved, but it will take a long time because they FDA does not want to lose face in the way it has mishandled this review.

Cancer vaccines offer promise, but many challenges still remain.

Does Pharma Get a Refund?

The FDA charges pharmaceutical companies user fees to speed up the process of drug reviews. Back in the 1980s, it used to take the FDA about three years to review drug applications. Under pressure from AIDS activists, the Prescription Drug User Fee Act (PDUFA) was passed and now reviews just over a year.

As part of the agreement, pharmaceutical companies are given a date (the PDUFA date) by which their product needs to be reviewed and given a thumbs up or thumbs down.

But what happens when the FDA doesn’t make the PDUFA deadline? It is becoming more and more frequent these days (see Reuters story). I did a quick back of the napkin review of a number of drugs that I’ve been following and it seems the FDA is missing the PDUFA deadline about 30% of the time.

So, does pharma get a refund of its PDUFA fees since the FDA hasn’t kept up with its end of the agreement?

Healing Patients or Do No Harm

In the U.S. today, doctors are focused on doing no harm (and avoiding malpractice suits), not necessarily in healing patients. Every year, doctors kill more than 58,000 people through preventable medical errors – that is more people than died in the Vietnam Conflict. And more people than die from breast cancer.

And the 58,000 preventable medical errors resulting in death doesn’t count the hundreds of thousands of patients who suffer significant injury from doctor’s mistakes.

A significant of these medical errors are drug based (inappropriate medication choice, wrong dose, improper patient education, etc.). Prescription medications are powerful weapons in a physician’s arsenal for treating disease. These powerful weapons require respect and appropriate utilization.

Physicians have big egos and value their roles as learned intermediaries. But if they want respect, they need to do a better job for caring for patients.

The lesson for patients and healthcare consumers is clear – be your own health advocate.

Provenge Shows Positive Results (Again)

Dendreon’s Provenge has showed positive results in an interim survival analysis for men with advanced prostate cancer. (See Dendreon press release) The company is close to demonstrating the necessary survival data that the FDA is now asking for. And, just as before, the safety profile of the product looks sound.

Provenge successfully met all endpoints for the first review and the FDA’s advisory committee recommended the drug for approval. In a controversial move, Dr. Howard Scher, a physician with financial ties to a competitive product, lobbied the FDA to keep the drug off the market. Dr. Scher was able to successfully turn the Hippocratic Oath into The Hypocrite Oath.

I have no doubt that Provenge will eventually get approved. The product is universally agreed to be safe and has demonstrated some efficacy. Provenge isn’t going to cure all men of prostate cancer, but it will help some.

But the approval of Provenge won’t happen any time soon. The FDA can’t afford to lose face on this issue and Dr. Scher will marshal all of his friends to try and keep the drug off the market.

Free Drugs

This article could be easily be entitled Hijacked Pharmaceuticals. Quietly, there is a growing problem of stolen pharmaceuticals in the United States.

Pharmaceuticals, like 70% of the products in the U.S., are shipped by truck. And these trucks sometimes need to stop. And that’s when problems are occurring. The trailer is disconnected from the tractor and hauled off. The Dept. of Homeland Security, FBI and various local law enforcement agencies have been investigating a rash of truck thefts and it seems like an inside job. Employees of the contracted trucking company tip off the thieves (typically an organized crime ring). The trucks are taken to an urban center, the drugs are offloaded and split up, and then the trailer is dumped in an undesirable neighborhood.

Meanwhile, the drugs are destined for the black and gray market. Drugs like Watson’s generic version of Vicodin, EPOs and erectile dysfunction drugs are sold on the black market here in the U.S. And drugs for rheumatoid arthritis, Fosamax and other significant medical conditions seem to be shipped overseas and dumped on local markets. Numerous drugs with U.S. labeling have been showing up in Western Europe and South America (without proper paperwork and at steeply discounted prices). It's a kind of reverse importation system.

But here’s the problem – many drugs for conditions like rheumatoid arthritis need to be temperature controlled. When the thieves take the drugs, they often don’t ship the drugs in temperature controlled containers, rendering the drugs sub-potent or completely ineffective. Patient’s lives are being put at risk.

Of course, RFID and chain-of-custody protocols can minimize some of this, but the supply chain for pharmaceutical products is still vulnerable.