Mark Horn MD Presents at Bloomberg on Behalf of THI

 

Dr. Mark Horn, our esteemed Chief Medical Officer, will present at a forum sponsored by Bloomberg Government. Dr. Horn will review a body of work PIPC (see below) has done to facilitate the participation of physicians and patients in defining PCORI’s (see below) research priorities and helping achieve the goal of genuinely patient centered research. The objectives include both identifying the issues these key constituencies deem most important and addressing them in ways that translate into improved health outcomes. What an honor for Mark Horn to represent Target Health at this forum.

 

 

 

Holiday Time at Target Health Inc.

For those who have not yet visited Target Health, we are located at 261 Madison Avenue in Manhattan (NYC) and have two floors there. On the 23rd floor, we have our Statistics, Data Management and IT Departments; and on the 24th floor we have our Clinical, Regulatory, HR and Business Departments.

 

Decorations at the Target Health 23rd floor conference room

 

Decorations at the entrance to the Target Health  IT Department, on the 23rd floor

 

 

Decorations at the spacious reception area on the 24th floor, with reception desk to the right, and the 24th floor conference room, barely visible, to the left

 

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Alert: Mixing Grapefruit with Certain Medications can be Deadly

 

Editor’s note: We all sort of know this about grapefruit, but a recent study shows that we need to be more aware than we have been.

 

 

Grapefruit lovers beware: Mixing the tart citrus with certain drugs can be deadly, according to a new study published Monday in the Canadian Medical Association Journal. There are 84 drugs that interact 1) ___ with grapefruit in its various forms, even when patients don’t consume much of it, according to this recent study. It was also found that the number of common prescription drugs that can cause dangerous interactions with grapefruit is 2) ___.

 

Twenty-six new drugs that can cause serious 3) ___ when mixed with grapefruit have been introduced in the past four years alone, bringing the total to 43, said Dr. David Bailey, a clinical pharmacologist at the Lawson Health Institute Research Center in London, Ontario. That’s an average of more than six new drugs a year. “It’s hard to avoid putting a 4) ___ out on the market that is not affected by grapefruit juice.” However, not all have serious consequences. Those that do, however, can cause problems, such as acute kidney failure, respiratory failure, gastric bleeding and worse. For example, the heart drug dronedarone, or Multaq, has a very high risk of interaction when taken with grapefruit, which may cause a rare form of ventricular tachycardia or rapid 5) ___ rhythm. Another example is mixing grapefruit with the prescription painkiller 6) ___ which can cause serious breathing problems. Also, adding grapefruit to a dose of the popular statin simvastatin, or Zocor, can lead to rhabdomyolysis, a breakdown of muscle fibers that can lead to kidney damage.

 

The problem with mixing grapefruit and some medications has been known for two decades, ever since Bailey and his colleagues first discovered that ingestion of the fruit with certain prescription drugs can concentrate the 7) ___ in a patient’s bloodstream.

 

Drinking less than a cup of grapefruit juice once a day for three days, for instance, can lead to a 330% concentration of simvastatin. And it doesn’t matter whether the 8) ___ is consumed hours before the pills. The problem is caused by an active ingredient in some citrus fruits, including grapefruit, limes and pomelos. Even the Seville oranges used in marmalades can trigger it. The fruits produce organic chemical compounds called furanocoumarins, which interfere with a human digestive enzyme. That enzyme, called CYP3A4, helps metabolize toxic substances to keep them from getting into the 9) ___. Typically, that means the enzyme inactivates the effects of about 50% of all medications. Doctors can, theoretically, adjust for that when prescribing drugs.

 

However, when the furanocoumarins in citrus inhibit that enzyme, the drugs can become concentrated in a patient’s system. In some cases, it can be like getting a triple or quadruple dose of medication. Drugs known to interact with grapefruit do carry warnings, but Bailey said he believes that neither doctors nor patients may take the threat seriously enough. “Basically, most people are sort of aware of grapefruit juice drug interactions, but I don’t think it’s in the forefront of their mind on a regular basis,” he said. It’s not clear how many people actually are harmed by grapefruit interactions, mostly because the side 10) ___ are often not recognized as being related to the citrus, said Bailey, who included eight case reports in his study. Part of the concern lies in the fact that people older than 45 are most likely to consume grapefruit juice — and to take prescription drugs. Seniors older than 70 years of age have the most trouble tolerating excessively high levels of drugs.

 

Patients worried about the interaction of grapefruit with their medications should talk with their doctors, Bailey said. And doctors should make sure to ask about grapefruit consumption when prescribing drugs.

 

Some grapefruit lovers may have cut back already because of the risk of drug 11) ___. Consumption of grapefruit juice has dropped in the past decade, falling from .44 gallons of juice per person per year in 2000 to 0.15 gallons per person in 2011, according to figures from the Florida Department of Citrus. Officials there say that although some drugs do interact with grapefruit, most do not. In most cases, doctors can prescribe drugs in the same class that don’t interact, noted Karen Mathis, a department spokeswoman. “These medications often can provide the same therapeutic effect with no need to avoid grapefruit juice,” she said in a statement. And not all citrus poses a problem, Bailey noted. Sweet oranges, such as navel and Valencia varieties, don’t contain the damaging compound. “You have an alternative there,” he suggested. “If you want to take your medications with 12) ___ juice, you’re home free.”

 

ANSWERS: 1) negatively; 2) rising; 3) harm; 4) drug; 5) heart; 6) oxycodone; 7) medication; 8) grapefruit; 9) bloodstream; 10) effects; 11) interaction; 12) orange

 

 

http://herbs-treatandtaste.blogspot.com/2011/05/grapefruit-history-medicinal-uses.html

Grapefruit

 

 

The grapefruit is a subtropical citrus tree grown for its fruit which was originally named the “forbidden fruit” of Barbados. The fruit was first documented in 1750 by Rev. Griffith Hughes describing specimens from Barbados. All parts of the fruit have uses. The fruit is mainly consumed for a tangy juice. The peel is expressed into an aromatherapy oil and is also a source of dietary fiber. The seed and pulp as a by-product of the juice industry is sold as cattle feed and is manufactured for use to make an extract. GSE (grapefruit seed extract) was originally developed by Dr. Jacob Harich, a nuclear physicist. In 1963, Harich journeyed to Florida, the heart of grapefruit country, and began researching and later marketing of GSE. Aubrey Hampton, founder of Aubrey Organics, has promoted citrus seed extract, a component in “Aubrey’s Preservative”, for more than 25 years.

 

In Pakistan and India grapefruit pulp was believed to prevent and cure dysentery, diarrhea enteritis, typhus and other digestive tract disorders. Also believed to cure fatigue was a glass of equal parts of lemon juice and grapefruit juice. Grapefruit juice was also felt to be an effective diuretic, and to help eczema sufferers when it is drunk. Grapefruit also lowers cholesterol levels. It is felt that grapefruit stimulated the appetite. Grapefruit seed extract is a compound made from the seed, pulp and rind of the fruit in most cases.

 

In Chinese medicine, citrus fruits are contraindicated when combined with certain herbs. According to traditional Chinese medicine, grapefruit has a cooling effect on the body. Eating grapefruit is thought to be especially helpful for those people suffering from weak digestion, a decreased appetite, stomach fullness, alcohol intoxication, and dry cough.

 

For stomach problems like nausea, vomiting, stomach ache, diarrhea and digestive obstruction the following was prescribed: Simmer the whole fruit, including the peel, with honey and drink as a tea. For phlegm disorder especially of the lung;

 

Bronchitis with viscous yellow phlegm: Mix grapefruit skin with inner white pulp chopped with honey and rice wine. Take this morning and evening

 

Itching skin, unexplained rash: Wash one sour grapefruit, place inside a pot, add water, boil, then switch to slow fire, boiling sap to slag juice. Wash area of skin itch or rash, with this solution, 3 times a day.

 

Pain caused by inflammation: 5-8 grapefruit, about 500 ml of honey, about 100 grams of crystal sugar, about 10 ml of ginger. Grapefruit peel to core, twist juice, into a pot, boil, then switch to slow fire, fry thick, add honey, rock sugar and the ginger with the revolve paste, cool, bottle and reserve. Take 20 ml of this medicine, 2 times per day, along with boiling water Chongfu.

 

Treatment of abdominal pain and diarrhea: Take 1 ripe grapefruit and cut the top off. Remove the flesh and put into 100 grams of green tea and then cover and put in a cool place for more than 1 year. After 1 year, take this with boiling water, as a tea.

 

Grapefruits come in three colors, yellow or blond, pink and red, the colors describing the flesh and not the rind. It is believed by some that the red grapefruit, which contains lycopene, has medicinal value for prevention of prostate health for men as well as for erectile dysfunction. Grapefruit of all descriptions contain a lot of vitamins C, E and A as well as B-complex ones and minerals such as calcium, copper, iron, magnesium, manganese, potassium, phosphorous, selenium and zinc. Grapefruits also contain some Omega -3 and -6 fatty acids and 16 amino acids. Some people still think that grapefruit has potent antioxidant properties and are good to ward off and help cure colds and flu as well as having anti-inflammatory properties so good for osteoarthritis, rheumatoid arthritis and asthma. It is also still believed by some that grapefruit is cardiovascular protective and protects against strokes and cancers.

 

Grapefruit contains large quantities of a simple polyamine called spermidine, which may be related to aging. It is known to be necessary for cell growth and maturation, and as cells age their level of spermidine is known to fall. Scientists have shown that feeding spermidine to worms, fruit flies and yeast significantly prolongs their lifespan. In addition, adding spermidine to the diet of mice decreased molecular markers of aging, and when human immune cells were cultured in a medium containing spermidine, they also lived longer.

 

 

New Rheumatoid Arthritis Drug Targets NIH-Discovered Protein

 

Editor’s note: Why shouldn’t NIH get “a percentage” of any drug product developed with government funds. Think about it. It might make healthcare “free” in the US.

 

Affecting nearly 1.5 million adults, rheumatoid arthritis (RA) is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. It occurs when the immune system, which normally defends the body from outside invaders such as bacteria and viruses, attacks the membrane that lines the joints.

 

The FDA has recently approved a new oral medication for the treatment of RA that represents a new class of drugs for the disease. The drug, tofacitinib (Xeljanz), provides a new treatment option for adults with moderately to severely active RA who have had an inadequate response to, or who are intolerant of, methotrexate, a standard therapy for RA. Tofacitinib is from a new class of drugs developed to target Janus kinases. One member of this family, JAK3, was discovered in the early 1990s by a NIH laboratory in the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Subsequent studies carried out at the National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the NIAMS, showed that genetic defects in JAK3 can cause severe combined immunodeficiency. This discovery led to the idea that drugs blocking Janus kinases would suppress the immune system and might be protective against the damaging inflammation of rheumatoid arthritis and certain other autoimmune diseases.

 

The approval of tofacitinib represents the first time in a decade that the FDA has approved an oral disease modifying antirheumatic drug, or DMARD, for the treatment of RA. This broad class of drugs slows or halts the progression of damage from the disease, rather than merely providing relief from symptoms. Unlike biologic treatments for RA — which are also DMARDs and target immune system proteins — tofacitinib is a pill, not an infusion or an injection. It is the first Janus kinase inhibitor to receive an FDA approval for RA.

 

JOHN J. O’SHEA, M.D., scientific director of the NIAMS, is the NIH researcher who discovered JAK3 and first cloned the human form of the protein. In 1993, shortly after O’Shea and his team discovered the JAK3 protein and established its role in inflammation, O’Shea learned that scientists at Pfizer were searching for drug targets to tackle autoimmunity and transplant rejection. Subsequent discussions led to an innovative public-private collaboration between NIH and Pfizer, through a cooperative research and development agreement. This agreement allowed teams from both organizations to work together toward the common goal of finding a new immune-suppressing drug for this debilitating disease.

 

WARREN J. LEONARD, M.D., director of the Immunology Center in NHLBI, is a pioneer in immune research whose group first identified the genetic mutations that are responsible for X-linked severe combined immunodeficiency (XSCID), commonly known as the “Bubble Boy Disease.” Leonard, in collaboration with O’Shea, then demonstrated that the protein that is defective in XSCID associates with JAK3, and that humans with mutations in JAK3 have a form of immunodeficiency clinically similar to XSCID. That discovery led to their hypothesis that JAK3 inhibitors might be potent immunosuppressive agents, as is the case for tofacitinib.

Drug Resistance and Pseudoresistance: An Unintended Consequence of Enteric Coating Aspirin

 

Roughly one-fifth of Americans take low-dose aspirin every day for heart-healthy benefits. But, based on either urine or blood tests of how aspirin blocks the stickiness of platelets – blood cells that clump together in the first stages of forming harmful clots – up to one third of patients are deemed unlikely to benefit from daily use. Such patients are called “aspirin resistant.” Clots are the main cause of most heart attacks and strokes.

 

Despite this concern, no clear definition of “aspirin resistance” has emerged and estimates of its incidence have varied remarkably. As a result, a study published online in Circulation (4 December 2012), was performed to determine the commonality of a mechanistically consistent, stable and specific phenotype of true pharmacological resistance to aspirin – such as might be explained by genetic causes.

 

For the study, 400 healthy volunteers were screened for their response to a single oral dose of 325 mg immediate release or enteric coated aspirin. Response parameters reflected the activity of aspirin’s molecular target, cyclooxygenase-1. Individuals who appeared “aspirin resistant” on one occasion underwent repeat testing and if still “resistant” were exposed to low dose enteric coated aspirin (81 mg) and clopidogrel (75 mg) for one week each. Variable absorption caused a high frequency of apparent resistance to a single dose of 325 mg enteric coated aspirin (up to 49%) but not to immediate release aspirin (0%). All individuals responded to aspirin upon repeated exposure, extension of the post dosing interval or addition of aspirin to their platelets ex vivo.

 

According to the authors, pharmacological resistance to aspirin is rare and the study failed to identify a single case of true drug resistance. However, pseudoresistance, reflecting delayed and reduced drug absorption, complicates enteric coated but not immediate release aspirin administration.

Long-Term Effects of Continuing Adjuvant Tamoxifen to 10 Years Versus Stopping at 5 Years After Diagnosis of Estrogen Receptor-Positive Breast Cancer

 

For women with estrogen receptor (ER)-positive early breast cancer, treatment with tamoxifen for 5 years substantially reduces the breast cancer mortality rate throughout the first 15 years after diagnosis. As a result, according to an article published in The Lancet, Early Online Publication (5 December 2012), a study was performed aimed to assess the further effects of continuing tamoxifen to 10 years instead of stopping at 5 years.

 

In the worldwide Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) trial, 12,894 women with early breast cancer who had completed 5 years of treatment with tamoxifen were randomly allocated to continue tamoxifen to 10 years or stop at 5 years (open control). Allocation (1:1) was by central computer, using minimization. After entry (between 1996 and 2005), yearly follow-up forms recorded any recurrence, second cancer, hospital admission, or death. The current report is based on breast cancer outcomes among the 6,846 women with ER-positive disease, and side-effects among all women (with positive, negative, or unknown ER status). Long-term follow-up still continues.

 

Results showed that among women with ER-positive disease, allocation to continue tamoxifen reduced the risk of breast cancer recurrence (617 recurrences in 3,428 women allocated to continue vs. 711 in 3,418 controls, p=0.002), reduced breast cancer mortality (331 deaths vs. 397 deaths, p=0.01), and reduced overall mortality (639 deaths vs. 722 deaths, p=0.01). The reductions in adverse breast cancer outcomes appeared to be less extreme during years 5-9 than after year 10 (recurrence rate ratio 0.90), and 0.75 in later years, as well as for breast cancer mortality (RR 0.97 during years 5-9 and 0.71 after year 10).

 

The cumulative risk of recurrence during years 5-14 was 21.4% for women allocated to continue treatment vs. 25.1% for controls. Similarly, breast cancer mortality during years 5-14 was 12.2% for women allocated to continue treatment versus 15.0% for controls.

 

Treatment allocation seemed to have no effect on breast cancer outcome among 1,248 women with ER-negative disease, and an intermediate effect among 4,800 women with unknown ER status. Among all 12,894 women, mortality without recurrence from causes other than breast cancer was little affected. For the incidence rates of hospitalization or death rates fo specific diseases, RRs were as follows: pulmonary embolus 1.87 (p=0.01), stroke 1.06 (ns), ischemic heart disease 0.76 (p=0·02), and endometrial cancer 1.74 (p=0.0002). The cumulative risk of endometrial cancer during years 5-14 was 3.1% (mortality 0.4%) for women allocated to continue versus 1.6% (mortality 0·2%) for controls.

 

According to the authors, for women with ER-positive disease, continuing tamoxifen to 10 years rather than stopping at 5 years produces a further reduction in recurrence and mortality, particularly after year 10. These results, taken together with results from previous trials of 5 years of tamoxifen treatment versus none, suggest that 10 years of tamoxifen treatment can approximately halve breast cancer mortality during the second decade after diagnosis.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.

 

FDA:  Advancing Breakthrough Drug Therapies

 

The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development. This is the fifth authorization of the Prescription Drug User Fee Act or PDUFA, first enacted in 1992, and the third authorization of the Medical Device User Fee Act, or MDUFA, first enacted in 2002. Both programs have provided steady and reliable funding to maintain and support a staff of trained reviewers who must determine whether a proposed new product is safe and effective for patients and do so within a certain time period. The new user fee programs for generic drugs and biosimilar biologics build on the successes of these two established user fee programs.

 

Extracted From FDA Voice: By: Janet Woodcock, M.D.

 

Thanks to a recent law that went into effect on July 9, 2012, FDA now has a new program to help expedite the development of new drugs that could potentially offer a substantial improvement over existing therapies for patients with serious or life-threatening diseases. The new law is designed to get “breakthrough” therapies developed as quickly and safely as possible so they can be available to treat the patients who need them. Recently FDA has identified the first therapy to receive this special designation and there is lots of interest in the pharmaceutical industry in taking advantage of this new development tool. FDASIA defines a “breakthrough” therapy as one that is “is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.” In other words, a breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments.

 

This new option will complement the three programs that FDA ahs used for many years to help speed up the development and review of especially important new drug therapies. They’re called “expedited drug development and review” programs, named Fast Track, Priority Review and Accelerated Approval. Each one is different, but for simplicity, think of them as various ways of bringing potentially important new therapies to patients sooner. These programs have been very successful and are part of the reason that FDA leads the world in first approvals of innovative new drugs.

Janet Woodcock, M.D. is the Director of FDA’s Center for Drug Evaluation and Research

 

Versatility of Grapefruit

 

Editor’s note: Just a note of caution to our readers, who may be taking any prescription drug(s).  Before you try any of the recipes, below, check with your doctor to see if you are at risk for any serious grapefruit/drug interactions.

 

Grapefruit Margarita

 

Ingredients

 

Grapefruit segments cut into quarters

salt

3/4 cup of grapefruit juice

6 oz tequila

2 oz Cointreau or Triple Sec

2 cups cracked ice

 

Directions

 

1. Rub the cut grapefruit segments around the rim of cocktail glasses then swirl them in a mound of salt to coat the rims.

2. Blend the liquids until smooth.

3. Pour into cocktail glasses and garnish with a grapefruit quarter (or smaller)  and/or a slice of lime.

 

 

Red Snapper with Grapefruit & Tarragon

 

 

Ingredients

  • 1/4 cup minced shallot
  • Four 6- to 8-ounces fillet of Red Snapper
  • 1/4 cup plus 2 tablespoons dry white wine (cooking wine is not as good)
  • 1/4 cup plus 2 tablespoons bottled clam juice
  • 2/3 cup fresh grapefruit juice
  • 1/4 cup heavy cream or almond milk (lowest calories) or buttermilk or half&half or plain yogurt
  • 6 Tablespoons extra virgin Olive oil
  • 2 teaspoons minced fresh tarragon leaves or 1/4 teaspoon crumbled dried, or to save (save a little extra for garnish)
  • fresh grapefruit sections as an accompaniment

Directions

1. Sprinkle the shallots into an oiled shallow baking dish just large enough to hold the fish fillets in one layer. Be sure the dish has a cover.

 

2. On top of the shallots arrange the fillets, skin sides down, and pour the wine and the clam juice over them. Sprinkle the fillets with salt and pepper to taste and bake them, covered, in the middle of a preheated 425°F. oven for 10 to 12 minutes, or until they are just cooked through. Just before the fish is done, raise the oven temperature and uncover the fish. Let it get a golden brown color and then take out of the oven. Transfer the fillets with a slotted spatula to a platter and keep them warm, and covered.

 

3. Strain the cooking liquid through a fine sieve into a small saucepan, and add the grapefruit juice, and boil the mixture until it is reduced to about 2/3 cup. Add the almond milk and boil the mixture until it is reduced by half. Reduce the heat to low and whisk in the olive oil, a little bit at a time, lifting the pan from the heat occasionally to let the mixture cool. (The sauce should not get hot enough to liquefy. It should be the consistency of thin hollandaise.) Whisk in the tarragon and salt and pepper to taste.

 

4. With a slotted spatula transfer each fish fillet, skin side down, to a plate. Pour one fourth of the sauce over each fillet and arrange some of the grapefruit sections around each plate. Garnish with a few sprinkles of fresh tarragon.

 

Serve with your favorite tossed salad, your most delicious pasta, and warm grainy rolls and/or bread to mop up the delicious sauce. I don’t think Chardonnay would go well with the grapefruit, so try a nice chilled Sauvignon Blanc or a Pinot Gris.

 

Pharmaceutically Speaking

 

Editor’s Note: Is the danger here the loss of the “right of free speech” or challenges to the “public safety”? One compromise is to promote off-label use of medications only to physicians, from peer reviewed journals like the article above on long-term use of tamoxifen for the treatment of breast cancer published in the Lancet.  With all of the discussion about “free speech” and “court opinions,” nothing is more important than the rights of patients and treatment outcomes. 

———————————————————————————————————

By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.

 

In a decision sure to evoke passionate responses, pro and con, a US Appeals Court (Second Circuit) ruled in favor of a pharmaceutical industry representative and against the Government in a free speech case involving “off-label” promotion.

 

Basically, the Court has found that the Government does not have a compelling interest in forbidding speech about the use of a legally marketed product. The Court (Judge Denny Chin, quoted in the Wall Street Journal, Editorial December 5th, 2012, page A18), perhaps anticipating critics who will warn of risks to the public, noted that “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”

 

The FDA prohibition against pharmaceutical companies initiating discussions of unlabeled uses of approved medicines, uses that may be medically appropriate but not officially approved by the FDA, has long been a challenge for industry. It has also proven quite expensive for the firms and sometimes resulting in multiple billion dollar fines.

 

My impression is that the issue is less emotionally compelling for the broader practitioner community which, especially in the current environment, has an array of more practically impactful health policy concerns. However, it has been my perception over the years that physicians are often perplexed by constraints on the industry representatives that they see; the justifications for the restraints are often not intuitively obvious.

 

Irrespective of how one feels about the pros and cons of this unique speech prohibition, there is something seemingly “unfair” to Americans about someone telling you not to speak, because you are “not allowed to talk about that and to call Headquarters”. To some, it simply doesn’t feel right, despite the presumably salutary intent.

 

The profound implications of this ruling – it has the potential to transform the marketing of medicines, including advertising directly to consumers – make it likely that it will be appealed. Should the Supreme Court agree to address the issue it could be some time before we have closure.

 

The interim landscape promises to be interesting. Will FDA, for example, relax its enforcement of the prohibition against off-label promotion? If so, how will this be manifest? Will companies be aggressive and change marketing and sales strategies to exercise their (presumed) new freedoms, or will they act cautiously, perhaps fearful of angering regulators? These are unanswerable questions. It will be fascinating to watch, with much at stake, as companies and regulators reset their behavior in a changed, and potentially charged environment.

 

Whatever happens, the Court’s opinion seems (to me at least) consistent with the times. In an era of consumer empowerment and unfettered access to vast amounts of information on virtually any topic the prohibition on speech by industry about its own products increasingly seems anachronistic. Concerns that patients will be misled and put at risk by product information coming from a biased source, (likely to be expressed by many people of good will), while legitimate, have in many ways been superseded in a society that has apparently determined that free access to information is the higher value. However, the quintessential “American” challenge is to develop processes to assure that providers of information behave responsibly so that the public can accurately assess available information. This will not be an easy hurdle to overcome.