Mission Impossible?

Greedy drug companies. Fake data. Drug recalls. Corrupt research scientists. We’ve seen it all from Big PHARMA in recent years.

But not everyone on the inside has his head in the sand. Take, for example, my colleague Dr. Phil Fontanarosa. Today, he’s the Executive Editor at the Journal of the American Medical Association (JAMA).

This Dr. Phil is a real doctor. He does not just play one on TV. And he recognizes that Big PHARMA has a major credibility problem. With patients and physicians alike. To address this problem, Dr. Fontanarosa recently published an editorial in JAMA called, “Restoring confidence in the pharmaceutical industry.” 

Like me, Dr. Fontanarosa can remember a time when real health professionals–not corporate marauders–ran the pharmaceutical world. They looked for and found real breakthroughs for real diseases. And their breakthroughs had to first pass muster with physicians. Not just the bureaucrats at the FDA.

But then came the era of blockbuster drugs…

Corporate marauders now run Big PHARMA. The industry invents new diseases–such as low T–just to match new drugs cooked up by accident in a lab.

And millions of Americans now buy and take these drugs. Whether they need them or not. They buy them because they suddenly discover they have a new “risk factor.” Or even a new “medical” disorder. Not because they have any real, treatable medical condition.

Big PHARMA has also stopped developing “orphan” drugs. They stopped searching for drugs that could help alleviate true human suffering. Or at least stopped making them available. These drugs were not profitable enough. In fact, it’s an open secret that PHARMA has all-but-abandoned development of true new therapeutic breakthroughs.

In recent years, we have also seen fraud, abuse, and outright lies from scientists working for Big PHARMA. Even in the labs of many of the most prestigious drug companies.

Beyond the suspicious research, Big PHARMA uses fraudulent and unethical marketing practices. I remember one drug company hired former cheerleaders on its sales force. These professionals promoted new drugs to doctors–back when most doctors were men–wearing cheerleading uniforms.

Dr. Fontanarosa recognizes this lack of trust in the pharmaceutical industry. He says it threatens the future of medical research. And he also says there are several things that PHARMA can do to restore confidence.

But will it be enough?

First, he says academic investigators–who are not drug company employees–should perform medical research studies. Many academic research groups already insist that an academic statistician–without any financial interest in the study outcome–conduct the analysis. This sounds like good, common sense. If you stand to benefit from the research, you shouldn’t conduct the investigation.

Secondly, Dr. Fontanarosa says academic investigators should write the actual study papers. Of course, most U.S. scientists will never win a Pulitzer Prize for their writing abilities. Even the ones who can speak English. So, pharmaceutical companies often provide “writing assistance” to complete the reports of studies they sponsor.

This should stop, says Dr. Fontanarosa. Or at least carefully document the roles and identities of these ghost writers. He says this will provide some necessary transparency and accountability to research publishing.

Third, Dr. Fontanarosa says we need to make data from clinical drug trials publicly available to qualified investigators. For example, GlaxoSmithKline recently announced plans to make raw data from clinical trials available to researchers. Again, this just makes sense. The more transparency, the better.

Plus, the taxpayers ultimately pay for all the medical research not paid for by drug companies. So this would be a fair approach. This prevents agencies like the NIH and CDC from sitting on publicly funded research study data. Remember how the government denied our research team, led by a Nobel laureate, access to the NHANES data? This slowed our analyses that ultimately proved excess iron causes cancer.

Lastly, Dr. Fontanarosa says Big PHARMA should stop all the direct-to-consumer advertising. That means no more TV commercials of a man and a woman sitting in bathtubs, holding hands, and looking at the sunset. Or at the very least, they should wait until the drug’s been on the market for a while. Or until post-marketing studies are completed.

Direct-to-consumer advertising is illegal in most countries, as it was for many years in the U.S.

Dr. Fontanarosa says limiting direct-to-consumer advertising on new drugs will send a message that Big PHARMA values patient safety over profits. He says these common sense steps may help prevent some of the serious, adverse events not detected in the initial trials.

But my friend Dr. Fontanarosa may be more of an optimist than I am.

I’ve warned you before to avoid new drugs when they are first “approved” by the FDA. We can’t know a drug’s true risk and safety profile until after it hits the open market.

Plus, I don’t count on Big PHARMA or the FDA to take these common sense and common decency measures to protect consumers. Protect yourself. Don’t take a new drug until it has been on the market for at least seven years.

And when you see a ludicrous and offensive ad for a new drug, turn off the TV.

Also, do not go to your doctor and ask about some new miracle drug you heard about on TV. Or saw in a magazine. Or heard about on the radio. Talk to your doctor about your health. Not the latest drugs. Let him or her figure out what treatments to try for you.

By marketing drugs to you, these drug companies use you. You become their new salesperson, promoting their new drugs to the health care providers. Even without the cheerleading uniform.

You don’t work for the drug companies, so don’t do their marketing by pestering your doctor about new drugs.

Thankfully, many sensible and busy doctors have closed their doors in the faces of drug company salesman.

If a new drug has real benefits, without serious side effects, you can trust your doctor to find out about it. Their job is to help patients. And a legitimate drug breakthrough is a boon to doctors and patients alike.

But don’t confuse that with the latest “blockbuster” drug. And don’t fall for some new “made-up” medical condition either.

If we can restore integrity and trust in industry-sponsored research…and rigorous studies find that a new product can substantially improve your health–the world will beat a path to its door.

Source:
1. JAMA. 2013;309(6):607-609. doi:10.1001/jama.2013.58.


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