More Serious Questions About Prescription Drugs

Let me start with some statistics that both patients and health care professionals would probably prefer not to ponder:

• Nearly 70% of all Americans are taking one or more prescription drugs, the most commonly prescribed being antibiotics (17%), antidepressants (13%), and opioids (13%).
• The usefulness and safety of prescription drugs are supposed to be controlled by the Food and Drug Administration (FDA) through a complex process of clinical trials and data analysis. When a drug is approved, the financial rewards to the developing company are staggering (Lipitor =$942 billion).
• Unlike other developed countries, the US–including the FDA–has virtually no control over drug pricing. Big Pharma charges what the market will bear. You constitute that market and you pay for this chicanery through your federal taxes and skyrocketing insurance premiums. The Chicago pharma firm Novum over a period of 18 months raised the price of its acne cream by 3,900% to $9,561 for a 60-gram tube. The ingredients, a simple mixture of two generic creams, cost about $2.00 to produce.

Keeping these issues in mind, anyone with a lick of common sense would start asking some serious questions about the relationships among pill swallowing, Big Pharma, and the FDA.

To my mind, there are three very important questions:
(1) Do these medicines actually do anything once they’re inside us?
(2) Is the drug’s action actually useful?
(3) If the drug is useful, do its benefits outweigh its risks?

Because there’s so much money involved, it’s a sad fact that you, the pill-swallowing patient, can easily fall victim to the network of lies and corruption that lurk behind almost every prescription drug being sold today. What this means is that Big Pharma works mightily to convince the FDA that the answer to all three of the questions above is resoundingly positive. “Yes!,” they crow, “Our new chemical does something in the human body,” and “Yes yes! Our new chemical is useful,” and “Yes, the new chemical is safe.”

And then they add “And here are the studies to prove it.”

Unfortunately, too often the only accurate response is to #1. Most things you take into your body do something, whether you’ve swallowed a new drug or a ham sandwich.

However, the answers to #2 and #3 are highly suspect. Whether a drug is actually useful or safe is often glossed over by a deliberate misreading of the data or flat-out lying until years after a drug is released and the profits have been distributed to shareholders.

Take the concept of usefulness

Birth control pills (there are now 229 brands) do prevent pregnancy by futzing with your sex hormones. All in all, considering the tens of millions of users, they’re pretty safe, though many women stop taking them because of side effects. Thus, we can classify birth control pills as useful.

Statin drugs lower your cholesterol by changing the way your body manufactures its own cholesterol. But after nearly 30 years, many doctors remain unconvinced that lowering cholesterol with drugs does anything useful for a majority of users. Lowering cholesterol for heart disease prevention doesn’t hold a candle to the array of lifestyle changes that many people continue to ignore.

Every class of drugs–antibiotics, antidepressants, anti-inflammatories, all of them–will do something inside your body. But is that something both useful and safe? Has it been fully proven that taking a specific drug is better for your health and longevity than not taking it? This information is mostly withheld from you by a money-driven screen of smoke and mirrors.

New conflict-of-interest revelations

Not to ruin the taste of your latte this morning, but here are some thought-provoking new revelations:

• There’s a daunting amount of red tape required for Big Pharma to get FDA approval for a new drug, and this British Medical Journal study shows one solution. Big Pharma regularly lures high-level FDA employees into its fold as consultants in order to speed drugs through the approval process. Conversely, the Wall Street Journal reported that the FDA virtually never reveals that many of its advisors have significant financial ties to Big Pharma.
• The standards that define usefulness during the FDA approval process are in deep decline. Drugs that don’t seem to be doing much of anything (unimpressive results in drug vs. placebo clinical trials) are managing to get FDA approval. Many of the new weight-loss drugs, the recent Addyi for sexual enhancement, a new drug for muscular dystrophy, and even some of the new cancer chemotherapies are hitting the market with virtually no evidence that they do much of anything except make people sick and drain their wallets.
• Safety issues are not faring much better. Big Pharma is notorious for withholding safety data until a drug is near the end of its patent and the FDA is being flooded with post-marketing side effect reports from both patients and physicians. Between 2004 and 2010, Big Pharma paid $7 billion in fines, penalties, and lawsuits triggered either by withholding information about a drug or because of direct damage to patients themselves. $7 billion is a tiny fraction of Big Pharma’s profits, now estimated to be in the hundreds of billions annually.
• Are we wasting our time, money, and well-being for the profits of an industry of dubious moral worth? French researchers reviewed 979 new drugs released between 2002 and 2011 and found that more than 90% offered absolutely no improvement over drugs that had been around for years. This graph emphasizes the uselessness of the vast majority of new FDA-approved drugs, most of which are knock-offs of old standards, blatant copies as pathetic as Pat Boone’s “Wabapaloobopalopbamboom” cover of Little Richard’s Tutti Frutti.

You might think from this that I dislike all drugs. Of course that’s not the case. Some are truly spectacular, like the biologicals for multiple sclerosis, the antivirals for HIV, the chemotherapies for chronic leukemia, birth control pills, and pain meds. But I’m highly skeptical.  Far too many drugs are treating nothing but unhealthful lifestyle choices, including junk-food addiction and exercise phobia.

We swallow what we’re told by an authority figure who was visited by a Big Pharma drug rep 30 minutes earlier. We think the FDA is protecting us, not realizing that this powerful government agency can be held directly responsible for millions of deaths, kowtowing as it did to pressures from the tobacco industry when someone considered classifying nicotine as a drug.

A word about homeopathy

While this may seem like an abrupt change of subject, I want to end with some information on homeopathy, a 200-year-old branch of medicine that replaces potent chemicals with tiny amounts of substances from nature to trigger your body’s ability to heal itself. All around the world, physicians, dentists, and veterinarians include homeopathy in their practices. In the mid-19^th century, the American Medical Association, using “public safety” as an excuse when the real motive was financial, managed to quash homeopathy almost to the point of extinction. Sadly, the profession never fully recovered.

Should homeopathy replace all conventional pharmacologic therapies? Of course not. Is homeopathy safe? Extremely, unless it’s used when a conventional approach is mandatory (cancer, for example, or surgery). Should homeopathy be considered for acute and chronic symptoms that are not life-threatening? Probably worth a try. You can discuss using homeopathy with your primary care doctor or schedule a consultation with our homeopath, Sujatha Mannal.

For those skeptical of the science behind homeopathy, the FDA gave approval to all homeopathic remedies in 1938 and, despite the kicking and screaming of the AMA, has never rescinded that approval.

Be well,
David Edelberg, MD