口袋女优

In 2001, I led a large clinical trial that showed that

The news was carried live on major TV networks. During an interview, I was asked: "This trial was funded by a pharmaceutical company. Right?" I said yes.

The reporter continued: "Doesn't that make the data suspect?"

I was stunned by the question. For the record, the FDA audited the trial, verified its findings and expanded the indications for the drug. The trial's database is fully open to academic inquiry. The drug is used by millions of people.

Most people do not understand the drug development process. Many routinely ask whether industry-sponsored trials can be trusted.

Some believe: if industry has paid for a trial, it must be biased. Industry must have manipulated the data so the trial would come out with a positive result.

My reply: "If industry could do that, then why do most clinical trials show that the new drug doesn't work? Does that happen because companies are too incompetent to make the results come out the way they wanted?"

I have led about 20 major clinical trials. In the vast majority of the trials, the results were a major disappointment for the sponsor.

Some people love conspiracies. Sometimes they are right. Years ago, I believed the sponsor had manipulated the results of a trial. For the record, I was not involved in the trial, and I reported my concerns to the FDA.

The FDA had different concerns about the drug and asked for a second trial, which failed to demonstrate a benefit. The FDA never approved the drug.

But if you think that every industry-sponsored trial is suspect, then you live in a strange world. And a very dark one.

Some complain that companies design trials that are biased or unnecessary. Sometimes they do. I can think of many post-approval trials that are just silly.

But the major trials for drug approval are all vetted by the FDA before the trial starts. When the trial is completed, the database is sent to the FDA, and the FDA carries out its audits and does its own analyses. Its analyses may differ from the ones that are published in a peer-review manuscript. Discoveries of discrepancies are all in the public domain.

Some think that companies aren't asking the questions that really matter.

I agree.

Companies conduct trials that serve their interests. Many cardiovascular trials can cost over a quarter of a billion dollars. When you spend that kind of money, your goal is to find out if a drug or device works. Your goal is not to answer big questions in public health.

Yet, I still hear people say that industry can't be trusted doing trials on their own drugs. They need an independent organization to do them -- like the NIH.

Such a response makes me smile: "Really?"

"Do you want the NIH to spend millions of dollars of taxpayers' money to test a drug so that a private company will benefit from the profits?"

And I remind them. In recent years, the NIH carried out two very large trials in cardiology. One was called TOPCAT in patients with heart failure; the other was called SPRINT in patients with hypertension. Both trials were plagued with major operational problems, which limited the interpretability and usefulness of the trials. The NIH doesn't have the resources to carry out a trial with the monitoring that is needed to ensure integrity.

So I ask professional cynics: Which organization would you trust to give a reliable result?

Cynics might say that they wouldn't trust either organization. They will tell you that they only trust other cynics. And of course, cynics want you to trust them.

That is really scary. Our society is consumed by a crisis of trust. It is destroying our humanity and our potential.

So if you are reading my blog because you are looking for a professional cynic, I am really going to disappoint you.

But I can certainly give you a referral.

Comment