June 29, 2021

Bad Pharma Good Pharma: how Patients and their Doctors are fooled about the drugs sold to them.

Snake oil salesmen are alive and well in the 2000's.
They know how to use the Congress to overturn FDA new
review panel recommendations and market away.

Bad Science is simply not doing science right. If you cut corners, never repeat experiments to confirm they are reproducible, bury negative results, then you can end up with egg on your face as a scientist. At best, the target for teasing by your colleagues, or at worst a biomedical company that contributes to the illness or deaths of many people and who will never be trusted again in the science or medical world. As it should be. 

Bad science or medicine seems to happen when money is part of the motivation equation in the form of "for profit". Unfortunately, that is the context where most commercial Pharma research occurs, including clinical trials. With shareholders to pay, there is a strong executive pressure to get the product developed and flying out of the pharmacy on Doctor's prescription pads as soon as possible. This factor, profits, are one of the greatest conflicts of interest (COI) we must manage.

For all of us, as the patient, this can have bad consequences. For our Doctors, they may be making prescription decisions based on information that is skewed or incomplete. They can be in a position where they cannot even get the full story on many of the drugs they must choose from. The Pharmacist will be in the same position as your Doctor. The problem that is keeping all three of us in the dark is reporting bias on the part of the drug developer. That is, under-reporting of negative trial results, and basic cherry-picking of trial results. While we have currently, in the United States, a political effort to reduce government regulations, we already suffer commercial lobbying and political overriding of FDA biomedical science recommendations on drug approvals. This includes ignoring expert panel recommendations to not approve a drug and instead let the company market away. Essentially neutering the ability of the FDA to save us all from snake oil salesmen, even in 2018.

This reporting bias is really a problem and would be an even worst problem if we did not have an FDA. Many drugs turned down by the FDA analysis of all available clinical trials tend to have only a few positive results submitted for scientific publication to Science Journals. If it was left to companies to decide what to provide Doctors, and Doctors could only review the published literature, then many people would become ill from various drugs in development. Yet, that is what actually happens sometimes. 

Even when an FDA review panel wants to turn down a drug with concerns, sometimes big Pharma has big pressure placed on government bodies to overrule a scientific panel recommendation. Fortunately, this is not extremely common, but it does happen; the recommendations of FDA science panels do not always match the desires of the big company that wants to market the next big money-making drug. 

I would not recommend that you assume all FDA-approved drugs have problems, since many life-saving drugs are clearly useful and have played important roles in increasing the lifespan of the developed world. Antibiotics and vaccines are simple examples of many drugs that have let many of us reach adulthood in the 20th and 21st centuries. In the 19th century, many of us would not have made it to our teens, let alone adulthood. Just Google some old census records, and notice just how many kids from those large families never made it to adulthood in the late 1800s and early 1900s. Antibiotics and vaccines have changed that reality dramatically. While I would not want to go back to the pre-FDA days of snake oil, we still have some improvements to make as you can learn by checking out the talks below by Dr. Ben Goldacre. A UK physician and epidemiologist, he has become personally annoyed at the half-truths provided to him by big Pharma for drugs he has been trying to use effectively for his patients. Particularly antidepressants. If you are a Patient, Doctor, Pharmacist, Parent, Student (PreMed, Med, or Science), then you will enjoy Dr. Goldacre's lecture style. Below are great links to check out:

1) CLICK HERE for a story done recently by "On the Media" on the issue of "battling bad science", by National Public Radio.

2) CLICK HERE to watch Dr. Goldacre's recent TED talk in June 2012 in Washington DC. - What Doctors don't know about the drugs they prescribe. Learn some interesting facts about drugs that have caused over 100,000 people to die in the United States because of incomplete information, as well as how we may be wasting money on new drugs that are quite useless. Big Pharma does not mind if you stockpile the useless drugs though. From their viewpoint, the sales are made and dividends shall flow. Links below will take you to a few of the papers mentioned by Dr. Goldacre in his TED talk:

S. Swaroop Vedula, Tianjing Li, Kay Dickersin in PLOS Medicine.

Peter Doshi, Tom Jefferson, Chris Del Mar in PLOS Medicine.

Any Doctor or Medical Student who does not read the following open access paper from the NEJM will be at a great disadvantage to those who do: Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy. Eric H. Turner, Annette M. Matthews, Eftihia Linardatos, Robert A. Tell, Robert Rosenthal in the New England Journal of Medicine. 2008. vol 353 p.252-260

IF you are on your way to a medical career, I strongly recommend you check out the above information. Clinical trial data on the drugs you will use in your Doctor's arsenal will not be quite as clear as you may think. Especially in the modern phase of big new drug development for big profit, which we find ourselves in at this time in the 21st century.

Another TED MED talk by Dr. Goldacre is here: 

Many drugs are useful, and many drugs are not worth the risk, and the system we have for knowing which are which is sometimes a bit broken. To learn more about how the work of FDA physicians and science panels are sometimes "overruled" by external forces, I also recommend that you check out this radio talk interview with Dr. Sidney Wolfe, a well known American consumer health advocate at Public Citizen:      Dr. Sidney Wolfe, guest on the Diane Rehm Show, NPR

Many drugs that are now being prescribed to Americans after forces with COI get FDA panel recommendations overturned. These include drugs for diabetes, one of the most prevalent diseases in the US population. Please do, check out Dr. Goldacre's blog post on

"Sarepta, eteplirsen: anecdote, data, surrogate outcomes, and the FDA", from 2016. 

This article makes mention of rosiglitazone, also known as Avandia. While this drug does lower HbA1c levels (glycohemoglobin), it also increases your risk of heart attack. As such this drug was suspended in the European Union, but its still in use in the United States. Dr. Goldacre also makes the point that real-world outcomes are often not used as the endpoint in clinical trials used to get drug approval at the FDA and other agencies. Many pharmaceutical interests lobby hard to keep things this way. It is good for the bottom line, but is it good for you, me, and our kids?

Going into Medicine? Are you on many prescription meds? I recommend reading: "Worst Pills, Best Pills: A consumer's guide to avoiding drug-induced death." BUT, do not panic if you are taking a drug on the "bad list", check with your doctor before you stop taking medication or change it.

Good science is having all the facts. We need more good science to correct Pharma's current push to make Medicine into "more pills than Doctors". But, that is just my opinion. Read and listen and decide for yourself. 

Remember, be your own scientist. 

Ken Mitton

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