TEDTalk on what doctors don't know about pharma

Watch the original talk below and then read Ben Goldacre's followup at the Huffington Post.

Prescription for cancer?

The side effects of medications are probably one of the main barriers to successful treatment and compliance. Ideally, the risks and benefits of prescription medications should be weighed prior to exposure to the chemicals they contain – will they do enough good for the ailment while doing less, and acceptable, harm. This varies among patients, but some common threads may underlie these choices, such as whether a risk of malignant cancer is acceptable when treating a mild and/or non-lethal condition. Some prescription drugs do have known or assumed cancer risks, yet others have risks that were missed upon review for approval to sell them. Some with concerns are hormone replacement, eczema creams, rheumatoid arthritis injections, and cholesterol lowering drugs.

The cholesterol drug controversy

According to the CDC, current guidelines for cholesterol levels place 1 in 3 Americans into the at-risk group that would benefit from intervention. The American Heart Association (AHA) recommends that diet and exercise be attempted to lose weight and benefit cholesterol levels before considering drug treatment. If blood levels of LDL cholesterol still exceed 190 mg/dL in persons with no history of heart disease or 130 mg/dL in patients with coronary heart disease then the AHA recommends prescription intervention.

However, many doctors and researchers have questioned the guidelines aiming for a specific measure of cholesterol. In addition, the benefits of the cholesterol-lowering drugs called statins seem to be limited. Other types of cholesterol drugs are also in question since there are reports of severe side effects and death, counter productive to preventing premature death from heart disease.

The first recall of cholesterol-lowering drugs was of Bayer Pharmaceutical’s Baycol in 2001. It was linked to muscle wasting that lead to 31 deaths in the United States and at least nine abroad. At the time of the recall the drug was prescribed to an estimated 700,000 Americans. Patients were told to not worry about the other five statins on the market at the time. As quoted by CBS News, “Baycol has been linked to significantly more fatal cases than its competitors” according to Dr. John Jenkins of the FDA. His suggestion was that patients who suffer muscle pain should speak to their physician about a lower dose or a different medication. There was speculation that complications arose when Baycol was taken with another prescription drug, gemfibrozil, which lowers triglyceride levels. But that had been the situation in only 12 of the cases.

Cholesterol exists in several forms, as it is bound to proteins for transport within the body. Two forms recognizable from clinical discussions are good cholesterol (HDL, high density lipoprotein) and bad cholesterol (LDL, low density lipoprotein). In November 2006, Pfizer’s HDL-increasing drug torcetrapib was reported to increase patient blood pressure during clinical trials. This is problematic because high blood pressure is a risk factor for heart disease, the condition the drug is supposed to help prevent. The company’s response was that when taken in conjunction with their LDL lowering drug Lipitor, torcetrapib is beneficial. A month later Pfizer halted clinical trials, an $800 million loss for the pharmaceutical company according to Forbes, due to increases in patient deaths when taking torcetrapib in combination with the drug atorvastatin, also known as Lipitor.

The Solution to Handling High Cholesterol

Patients with heart disease, or those at high risk due to lifestyle or a family history, who have high cholesterol could benefit from prescription medications, but first they should attempt lifestyle changes, such as limiting dietary cholesterol intake, quitting smoking, and exercising. They should also consult a physician for appropriate advice. Even once on drug intervention, patients need to follow medication directions precisely and not ignore side effects, consulting a physician for suggested evaluations and when necessary for altered dosage or discontinuation in the presence of adverse effects.

Massachusetts is an example to follow

As of July 1, drug company gifts to doctors are banned in Massachusetts. The legislation also limits free meals and requires that companies report any payment for consulting or speaker fees that amount to more than $50. This law affects all companies that do business in Massachusetts, meaning that it will cover doctors all over the country who interact with the many biotech and pharma companies around Boston. This is a step forward for consumers and patients to be treated without the psychological imprinting of doctors towards certain drugs or devices and for an open and transparent indication of what companies foot the bill for a doctors' speaking engagements, preventing "educational programs" from being disguised marketing programs. They will likely still be such, but it will now be blatant. Firms say that this will make Massachusetts unfriendly towards their companies, but if other states follow, the companies will have no choice but to be open about their practices. This is a step forward for patients, and companies have to realize that life is more important than sales. Read more here.

28 weight loss herbal supplements contain dangerous ingredients

Normally the Food and Drug Administration doesn’t handle herbal supplements, but laboratory tests have shown the presence of unlisted ingredients or increased dosage in twenty-eight weight loss drugs sold as herbal or dietary supplements, thus avoiding FDA approval.

The FDA is warning that the undeclared ingredients are potentially dangerous. The agency is seeking a recall on the products and a crackdown on illegal sales.

The weight loss products are: Fatloss Slimming, 2 Day Diet, 3x Slimming Power, Japan Lingzhi 24 Hour Diet, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim, 8 Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim Plus, GMP, Imelda Perfect Slim, Lida DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrim, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0. Most of these products are manufactured in China.

Twenty-seven of the products were found to contain sibutramine, a Schedule IV controlled substance used in prescription obesity drugs that can result in high blood pressure, seizures, palpitations and heart beat irregularities, heart attack, or stroke. Some of the products contain 3x the recommended dose in prescription medications.

Phytoshape contained rimonabant, which has not been approved for use in the United States due to concerns about increased depression and suicide risks and other adverse neurological effects. It is known as Acomplia in Europe and sales were suspended in October. Rimonabant was linked with 5 deaths in June 2008 of the 720 adverse reactions over the previous 2 years.

Phenytoin, an anti-seizure medication, was found in trace amounts in 3x slimming power and Extrim Plus.

Phenolphthalein was found in eight of the products; it is a suspected carcinogen. It is also suspected of being genotoxic, meaning that it damages DNA. It was used in laxatives until 1999.

If you have used these products and experienced side effects, report them to the FDA’s MedWatch Adverse Event Reporting Program at http://www.fda.gov/medwatch/

For more information on these products and ingredients visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html

Thalidomide

Thalidomide-related birth defects. Source: Otis Historical Archives National Museum of Health and Medicine, CC2.0 license

 

Thalidomide is an experimental drug used for life threatening illnesses. It was the center of a dangerous controversy in the 1960s when scientists discovered that pregnant women given the drug for morning sickness gave birth to babies with severe birth defects. The flipper-like appendages resulted in a slang term still known today, and led to great challenges for 10,000 children born during the late 1950s. 

Changes for Children's Cold Meds

The drug companies are voluntarily adding warning labels to children's cold medications [broken link]. Bowing to pressure from pediatricians and doing what the FDA refuses to, the companies are advising parents to not give cold medications to children under the age of 4.

Parents should:

• Never give adult medications to the child.

• Never give antihistamines to help a child sleep.

• Never give more than one medication that contain the same ingredients (acetaminophen and antihistamines are the worse offenders).

• Speak to their doctor about potential treatments or medications.

• Follow directions and warning labels exactly.

• Keep all medication, over-the-counter and prescription, out of reach and out of sight of children.

Recommended read: The Big Fix

I would like to recommend the book "The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers" by Katharine Greider. The first few chapters have my head spinning. Loopholes, litigation, false patents, and stays against generics have increased the cost of medicine and limited patient options. Written about 5 years ago, the book provides some recent history and helps fill in the knowledge gaps about the pharmaceutical companies holding the lives of millions in their pocketbooks.

Recommended Reading - Selling Sickness

I read this book, chapter by chapter, as a starting point for a few articles I've done. Combined with the background given me by Laurie Garret's tome on the public health infrastructure, Betrayal of Trust, I have been able to search for more information including legislative decisions, FDA approvals and recalls, and even clinical data files.

It absolutely amazes me the extent to which the regulatory agencies and pharmaceutical companies fail the consuming public. Consumerism has changed medicine into an industry focused on business and profits, rather than a profession based on helping sick people get well or preventing healthy people from getting sick. I received my graduate degree from a medical school and I have taken courses with future doctors...I even taught future doctors! And I am appalled at the undermining that will occur when they have lives in their hands. Companies pay for conferences and "educate" about their medications and the diseases they treat. Companies hire PR and marketing firms to create new names for disorders and diseases so they will sell better. The FDA approves new treatments based on promises instead of results. Then later recalls some because they end up killing patients they were supposed to help.

I believe that the researchers working on the treatments truly want to create cures and real medicine. I believe that most doctors get into medicine to help people. I believe that the firms doing the selling are not trying to injure people. But when someone who knows nothing about medicine is told to take an idea and run with it...that is exactly what happens. People get hurt. And those people are downplayed in memos, made fearful by ambiguous commercials, and humored by paid representatives.

I recommend reading Selling Sickness: How the World's Biggest Pharmaceutical Companies are Turning Us All Into Patients by Ray Moynihan and Alan Cassels. It will give you control of your own health.

Pharmaceuticals in the drinking water

In March 2008, the Associated Press released the results of their 5-month investigation into the presence of pharmaceuticals in the water supply (such as birth control pills, antibiotics, antidepressants, and acetaminophen or ibuprofen) in the water supply of 24 major metropolitan areas.

They found a lot to be worried about. Not only are human medications being flushed down the toilet, literally, but drugs used on animals are making their way into the drinking water. The concentrations were well below the normal medical dosage, in tiny quantities of parts per billion or trillion, but the fact that antibiotics, antidepressants, and hormones were found in the drinking water of an estimated 41 million Americans has raised concerns among health officials.

Most drug byproducts, expelled from the body after a person has taken the pills or medication, are removed from the water supply during waste treatment. However, not all compounds are filtered out by current treatment methods. As the usage of pharmaceuticals increases, the amount of residue in the water may increase for both prescription and over-the-counter medications and there is currently no federal requirement for screening.

The investigation included testing results by U.S. metropolitan areas from California to New Jersey and Detroit to Kentucky and included watershed evaluations. The most notable finds from the U.S. Geological survey and local water authorities outlined by the report included 56 different pharmaceuticals in Philadelphia, anti-anxiety and anti-epileptic medications in the treated water of more than 18 million Southern California residents, sex hormones in San Francisco’s water, mood stabilizers in the Passaic Valley treatment plant that serves New Jersey, six drugs in Washington D.C.’s supply, and antibiotics in the drinking water in Tucson, Arizona.

However, not all areas test for all pharmaceuticals, greatly limiting what could be found. Also, more than half of the cities contacted for information by the AP did not respond, including Houston, New York City, Boston, Baltimore, and Miami, though watershed testing revealed hormones and pharmaceuticals in the New York water supply. The water authorities insist that the water is safe. The AP found that sometimes when the local water providers said the results of screening were negative, independent screeners had different results.

The contamination is not just an urban problem. Caffeine was found in the water supply of less populated areas and those who draw from a well are at risk of contamination from failed septic systems. Other countries are also at risk, studies have found Asia, Australia, Canada, and Europe to also have pharmaceuticals in their lakes, rivers, reservoirs, and streams.

Local environmental groups, such as Environment Colorado, are calling for the pharmaceutical industry to take responsibility. In a press release, the group called for drug makers to either re-engineer their medications to not make their way into the water supply or to pay for the cleanup and new treatment methods that are necessary. They voiced concerns about the development of resistant infections and the adverse health effects of hormone exposure.

Additional treatment methods and research are necessary because some compounds become more toxic when presented with chlorine, a common treatment chemical. Also, technologies such as reverse osmosis, which would solve the problem, are too expensive to initiate on the large-scale according to reports from environmental research and watchdog groups.